Speaker Biographies

Professor Adams has a Ph.D. in Cancer Biology from the University of London. After post-doctoral research at Imperial Cancer Research Fund and, as an EMBO Fellow, in the Vascular Research Division at Brigham and Women’s Hospital, Harvard, she began her laboratory in 1994 as a Wellcome Trust Senior Fellow at the MRC-LMCB, University College London. She is now Professor of Cell Biology in the School of Biochemistry, University of Bristol. Professor Adams’ laboratory researches on the molecular basis of cell interactions with extracellular matrix and extracellular matrix assembly. Interests are in normal tissue processes and the contributions of extracellular matrix proteins in fibrosis and carcinoma metastasis. The evolution of extracellular matrix and protein families such as thrombospondins is a parallel interest. Professor Adams is the current Editor-in-Chief of AJP-Cell Physiology, a Journal of the American Physiological Society.

Raquel Aires-Barros is a Full Professor in the Department of Bioengineering (DBE) at Instituto Superior Técnico (IST), Universidade de Lisboa, and researcher at the Institute of Bioengineering and Biosciences (IBB). Chair of the Section Downstream Processing of the European Society of Biochemical Engineering Sciences (ESBES); Vice-President of the Portuguese Society for Biotechnology and editor of Separation and Purification Technology Journal. Current research interests include the development of new separation processes with high performance and efficiency for purification biopharmaceuticals and the development of devices- "Lab-on-a-Chip" - for biomolecules purification.

Dr. Allen is a Project Leader in the biopharmaceutical industry with broad understanding of cell therapies and biologics development. He joined Dark Horse Consulting in 2019, bringing 15 years of experience overseeing clinical trials, regulatory submissions, process improvement, and development strategy. During his career, he has been a part of companies ranging in size and development stage from small entrepreneurial organizations to large corporate pharmaceutical companies. Before joining Dark Horse Consulting, he most recently served as Senior Director of Immunotherapy at Asterias Biotherapeutics, a small biopharmaceutical company developing embryonic stem cell-derived therapeutics for spinal injury and cancer, where he oversaw overall development strategy, cross-functional team leadership, and clinical trial initiation of the company’s allogeneic cancer immunotherapy platform therapy. He delivered substantial progress of the cancer immunotherapy pipeline asset and a large part of his role was representing the organization to investors and at scientific conferences.

Tudor Arvinte studied Physics at University of Jassy, Romania, and received his Ph.D. in Biophysics from University of Düsseldorf, Germany. He held numerous research positions in Europe and the USA at Max-Planck Institute, Germany; C.N.R.S., France; Cornell University, New York; Texas A&M University; Ciba-Geigy UK; and Novartis, Switzerland. Dr. Arvinte worked with more than 200 biopharmaceuticals, three of his formulations reached the market, and he has over 90 publications and 15 patents. He is Titular Professor at Geneva University and CEO of Therapeomic, Inc. Basel, Switzerland, a contract research biotech company focused on the characterization and formulation of biopharmaceuticals.

Dejan Arzensek is a senior manager in Downstream Process Development department in Menges. He obtained his PhD in Physical Sciences from the University of Ljubljana. With a PhD degree in physics Dejan has a strong background in physical principles of protein association/aggregation, along with additional skills in mathematical modelling, statistical analysis and experimental biophysics. Dejan is currently responsible for managing the development team. He was a core member of the nextBioPharmDSP project of EU Framework Program for Research and Innovation “Horizon 2020” for which the goal is to drive drug process development towards Continuous Processing in Biopharmaceutical Manufacturing.

Fouad Atouf, PhD, is Senior Vice President, Global Biologics, at the United States Pharmacopeia (USP) where he oversees standards development, stakeholder engagement, and industry collaborations in support of the quality and safety of biological medicines. Dr. Atouf has been at USP for over 15 years and served in multiple leadership roles developing quality tools for biologics and establishing relevant reference material programs. In addition to leading the modernization of compendial standards, Dr. Atouf launched and implemented the biologics strategy focusing on technologies to support manufacturing and testing biological medicines. He has implemented new engagement models and collaboration approaches with academia, biopharma industry, and global government agencies. Dr. Atouf has a strong background in the regulation and standardization of pharmaceutical products including biologics and advanced therapies. Dr. Atouf is the author of numerous publications and is a frequent speaker at national and international pharmaceutical and regulatory scientific events. He holds a PhD in Cell Biology from the Pierre & Marie Curie University, Paris, France.

Dr. Eduard Ayuso is the CEO of Siegfried DINAMIQS, a CDMO providing manufacturing services, process development, quality control and analytics solutions. He also served as chairman of the Manufacturing committee of the European Society for Gene and Cell Therapy. He is an expert in the field of gene therapy using viral vector platforms, including their design, manufacture, and purification. He was previously the CTO at DiNAQOR, a genetic medicine platform company. He also served as Head of Innovative Vectorology at INSERM, and as the Scientific Director of the Translational Vector Core at the University of Nantes. Dr. Ayuso earned his Ph.D. in Biochemistry and Molecular Biology and his degree in Veterinary Medicine from the Autonomous University of Barcelona.

Niall Barron obtained a B.A. (Mod) in Microbiology from Trinity College Dublin and Ph.D. in Applied Microbiology/Biochemistry from the University of Ulster. He spent three years at Baylor College of Medicine as a postdoctoral scientist working on genome engineering strategies to study nuclear steroid receptor function. He then returned to Ireland to work on stem cell engineering at Dublin City University. Subsequently, as a senior scientist in DCU, he was instrumental in growing the mammalian cell engineering group with a specific focus on the production of recombinant therapeutic proteins. He was appointed NIBRT Principal Investigator and Professor of Biochemical Engineering in the School of Chemical and Bioprocess Engineering in UCD in 2017.

Iris L. Batalha is currently an Associate Professor and Group Leader at the University of Bath Dep. Life Sciences. She is also a Course Director in Nanotherapeutics at the University of Cambridge Institute of Continuing Education and a freelance Senior Innovation Strategy Consultant. From 2021 to 2024, she was a “La Caixa” Junior Leader and Senior Researcher at the Institute for Bioengineering of Catalonia (IBEC) in Barcelona, Spain. From 2017 to 2020, she was a joint Postdoctoral Research Associate (PDRA) at the University of Cambridge Engineering and Medicine departments. In 2019, she co-founded the non-profit organisation Women Ahead of Their Time (WATT) CIC and she also joined the University of Cambridge Peterhouse College as a Research Associate. From 2014 to 2017, she worked as a joint PDRA at MedImmune/AstraZeneca and University of Cambridge Chemical Engineering and Biotechnology department, followed by a brief experience as a healthcare/pharmaceutical competitive intelligence consultant. Her research interests and expertise lie in medical and pharmaceutical R&D, particularly nanomedicine, bio-inspired materials, downstream processing, formulation, and drug delivery.

Fethi Bensaid, PhD is heading Formulation and Process Development Section for Biotherapeutics at Sanofi Vitry site in France. In 2016, Fethi joined Sanofi as a Multimodal Formulation Manager with a focus on Drug Product Technology Transfer Management based on QbD approach. From 2017 to 2018, Fethi was a board member of the French Society for Nanomedicine (SFNano), a non-lucrative association whose objectives are to promote progress and knowledge diffusion in the Nanomedicine domain. Fethi began his career as a Scientist at Adocia, a biotechnology company, where his responsibilities involved developing innovative formulations for insulin products. In 2014, Fethi joined LFB Biotechnologies as a Team Leader with formulation and process development responsibilities with a focus on plasma proteins and monoclonal antibodies products from early stage up to LCM. Fethi obtained his PhD in Polymer Chemistry applied for Drug Delivery from Paul Sabatier University, in Toulouse - France, under the supervision of Dr. Didier Bourissou.

An experienced Product Manager, Christian has worked in both Europe and USA, and assisted leading companies with standardization of antibody, virus and cell therapy manufacturing processes. His broad understanding of process control requirements, has shaped the new NucleoCounter NC-202, designed to streamline cell counting across the entire pharma industry.

Greg has been at the cell and Gene Therapy Catapult since early 2017 and brings a wealth expertise in viral vector/cell line development, vector production in bioreactors and development of appropriate analytical tools for characterization and functionality assessment. Greg obtained his PhD in Virology and Immunology from the Ecole Normale Superieure de Lyon (ENS Lyon) in France, focusing upon the development of new Lentiviral vectors for the development of Dendritic cell-based immunotherapy. He then joined the department of Immunobiology and Infectious Disease at King’s College London as a post-doctoral researcher where his work focused predominantly on viral vector integration and immune cell dysfunction upon transduction. At CGTC, Greg is currently working with the process and analytical team to address the current challenges regarding viral vector manufacturing

Martin Bertschinger completed his Ph.D. at the EPFL in Lausanne (Switzerland) in the Laboratory of Professor Florian Wurm. After finishing his Ph.D. in 2006, Martin joined Glenmark Pharmaceuticals SA (Switzerland) in order to build teams for protein expression and cell line development. In 2019, Glenmark Pharmaceuticals span out its R&D unit into Ichnos Sciences. At Ichnos Sciences, Martin is leading the Drug Substance Development department (Cell Line Development, Upstream and Downstream Process Development).

Nadine Binai is a Senior Scientist in the Analytical Development department within Janssen Vaccines. Within the Product characterization team, Nadine works on comparability assessments, criticality analysis and characterization of product stability. Her broad background in analytical technologies, such as mass spectrometry as well as molecular methods helps her to contribute to develop vaccines that can potentially save millions of lives.

Eric has worked within the Biotechnology industry for 21 years. Eric was hired at Cygnus Technologies in, 2010 as the Vice President of Research and Development. His current responsibilities at the company include: business development, technical support, new product development,  custom services, along with being the Head of Research and Development Laboratory. Prior to joining Cygnus, Eric worked for MedImmune from 2002-2010. His responsibilities included: Analytical Representative on CMC teams guiding projects from IND to BLA submissions, Head of New Technology Development group, In-house host cell protein expert, Supervisor of 9 scientists in Immunoassay laboratory, and development, validation, Tech transfer of HCP and other analytical assays. Eric also worked for CropTech Development from 1998-2002. Eric has a Masters of Science in Biotechnology from The John Hopkins University in Baltimore, MD. , and a Bachelors of Science in Biology, with a Minor in Chemistry, from Radford University in Radford.

David Bittner studied Molecular Biology at the Westphalian University of Applied Sciences in Recklinghausen, Germany and holds a master’s degree in this field. Mr. Bittner joined the Eppendorf Bioprocess Center in 2019. As part of the Pan-European Sales Team he is responsible for the Ibérica region & parts of Germany. 

Clare Blue holds a degree and Ph.D. in Molecular Microbiology from the University of Glasgow, Scotland, UK. She has industry experience ranging from viral/vector manufacturing, biosafety testing, analytical development, QC and process development. Clare has been involved in AAV gene therapy for over 7 years, initially at Nightstar Therapeutics, where she held senior roles overseeing the manufacturing and analytical strategy of phase II/III AAV products for treating retinal diseases. In her current role as Director of Analytical / Product Development at Biogen, she acts as technical product development lead and analytical lead for several Biogen gene therapy products and also works to define the overall analytical, manufacturing and regulatory strategy to support the development of gene therapy products.

Diane I Blumenthal is currently Head of Technical Operations at Spark Therapeutics. Her responsibilities include: Manufacturing, Quality Control, cGMP and Scientific Facilities, Supply Chain and Network Strategy. She responsible for leading the CMC efforts that led to the first US approval of a gene therapy product which included the approval of the first US manufacturing facility to produce a gene therapy product. Diane has more than 30 years of experience in the use of recombinant DNA technology for the expression and manufacture of biotechnology products. Throughout her career, Diane has played a key role in the development and commercialization of multiple pharmaceutical products, including Erbitux® and Cyramza® and now Luxturna®. Prior to joining Spark Therapeutics, she served as Vice President of Manufacturing Sciences and Technology for Eli Lilly and Company, following the acquisition of ImClone Systems. While in this role, Diane was responsible for leading a multi-disciplinary team of scientists, statisticians and engineers tasked with providing technical support to manufacturing, development, quality control, quality assurance and regulatory teams. During her time at ImClone Systems, Diane and her team were responsible for the implementation of novel methodologies used for the demonstration process and product comparability. Diane has extensive experience in the transfer and scale-up of processes from the laboratory bench to commercial scale manufacturing with expertise in both microbial and mammalian cell culture expression systems and the corresponding downstream purification processes. Prior to her time at Lilly, Diane served as a scientific and manufacturing consultant to multiple start-up biotechnology companies and held scientific leadership positions at Zymquest, Inc., Scios, Inc. (formally California Biotechnology) and the Eastman Kodak Company. She received her M.S.E. in Chemical Engineering from Lehigh University and a B.S.E. in Bioengineering at the University of Pennsylvania.

Christopher founded Consulting on Advanced Biologicals Ltd. at the end of 2009, in order to focus his activities within the Regenerative Medicine sector. Advbiols Ltd. provides EU regulatory services to the regenerative medicine industry in addition to business and regulatory research and analysis to identify and focus on the real barriers to commercialisation of regenerative medicine. Christopher has a PhD in xenotranplantation immunology and spent 8 years in biotech (Imutran Ltd., a Novartis Pharma AG Co., and Intercytex) before joining the MHRA as a quality (CMC) assessor (biologicals and biotechnology unit). During this time, Christopher was involved with national implementation of the new Advanced Therapies Regulation and also involved through his participation in the CHMP’s cell products working party (CPWP) in implementation at the EMA level including drafting guidelines.

Bastian Budde from Bayer AG is a Senior Expert in Downstream Bioprocess Development. A biochemist by training, he earned his diploma and Ph.D. at the University of Munster, Germany and UC Santa Barbara, California. In a previous role as a Technology Manager at Bayer Leverkusen, he was responsible for development of bioprocess platforms and technologies for about 10 years. For the last 3 yearss, Bastian has been based in Wuppertal, Germany, heading a downstream purification lab responsible for development of bioprocesses (mainly for monoclonal antibodies) for preclinical and clinical programs. In this role, he constantly evaluates single-use technologies for all downstream unit operations and closely follows new developments in this growing industry sector. He is also currently implementing continuous and closed bioprocessing with massive utilization of single-use technologies for biological development.

Michael Butler is a Principal Investigator in Cell Technology at the National Institute of Bioprocessing Research & Training (NIBRT), Ireland, Adjunct Full Professor in University College Dublin as well as Distinguished Professor Emeritus of the University of Manitoba, Canada. He holds degrees in Chemistry and Biochemistry from the Universities of Birmingham, London (UK) and Waterloo (Canada). He was the scientific director of MabNet, a Canadian network for Mab production and founder of Biogro Technologies Inc., a spin-off company dedicated to serum-free media development. His research work focuses on the development of bioprocesses using mammalian cells for the production of recombinant proteins, monoclonal antibodies and viral vaccines.

Manuel Carrondo is Full Professor of Chemical and Biochemical Engineering at the Faculty of Sciences and Technology at NOVA University of Lisbon. He has extensive management experience in the biotechnology sector and heads iBET’s Business Development. His key areas of interest include (i) Animal Cell Technology and its application for human and animal health, (ii) therapeutic and diagnostic recombinant proteins, including fusion proteins, (iii) virus-like particles and pseudo viruses as vaccination agents and viruses (retro-, adeno-, lenti-) as deliverables for gene therapy, (iv) cell therapies and stem cells and (v) cGMP pilot plant scale-up and production development of biopharmaceuticals.

I did my Ph.D. at Bioprocess and Cell Engineering Group at Universitat Autònoma de Barcelona where I developed a project in the field of bioengineering devoted to the production of HIV-1 Virus-like particles as a platform for recombinant vaccine production. I combined my research with undergraduate teaching at UAB. After finishing my PhD, I enrolled as Postdoctoral Fellow at the Bioengineering Department at McGill University (Montreal, Canada), under the supervision of Prof. Amine Kamen. My research focused on the development of a production process for Influenza VLPs using the Baculovirus/Insect cell platform. Nowadays I have a position at UAB as a postdoctoral fellow working on the development of a bioprocess to produce Adeno-Associated vectors for gene therapy.

John Chappell is the Application & Service Director, EMEA and Asia Pacific, for Gyros Protein Technologies.  He has 25 years of CRO industry experience in preclinical and clinical drug development specializing in bioanalytical characterization including Pharmacokinetic, Immunogenicity and Biomarker analysis and is a Fellow of the Royal Society of Chemistry.

Philip is a pharmacist with academic and industrial research experience in drug development. He graduated from the University of Sunderland with an MPharm degree in 2012, and after undertaking pre-registration training between hospital and industrial pharmacy, completed a PhD at Durham University focusing on co-crystallisation as a technique to improve the properties of drugs. Following a post-doc position in the Northern Institute for Cancer Research (NICR) at Newcastle University developing a peptide based pro-drug, Philip is now based within the biologics downstream processing team at CPI. He is currently contributing to projects involving the development of an automated, integrated, continuous downstream process, and development and scale-up of a continuous non-chromatographic purification stage for monoclonal antibodies.

Dr. Ana Sofia Coroadinha has a Degree in Biochemistry (University of Lisbon) and a PhD in Gene Therapy performed at Généthon, Helmholtz Centre for Infection Research (HZI) and iBET, granted in 2005 by ITQB-UNL. Since July 2009 is the Head of Cell Line Development and Molecular Biotechnology Lab at iBET and ITQB-NOVA. She has over 20 years of experience in recombinant viruses and animal cell culture, areas where she has published over 50 peer reviewed papers. Dr. Ana Sofia Coroadinha group research focus on applied virology developing recombinant virus and molecular tools supporting the areas of gene therapy, vaccine development and virology.

Holly Corrigall received her PhD from the University of Aberdeen where she investigated the molecular response of eukaryote ribosomes to translational pausing. Holly then joined the Cell Line Development team within the Biopharm Process Research department at GSK where she supports the generation of commercial cell lines for GSK’s Biopharmaceutical portfolio.

Robin Curtis joined the Chemical Engineering and Analytical Science School at University of Manchester in 2003. Previously he did his PhD at the University of California at Berkeley and postdoctoral training at University of California Los Angeles and Rice University. His current research is focused on understanding the fundamentals of protein solution behaviour with an emphasis on elucidating non-specific protein-protein interactions and how they depend upon protein structural properties and the solution components including excipients. The approach relies on using a combination of light scattering methods (dynamic and static light scattering, electrophoretic light scattering) as well as computational approaches based on structural informatics and molecular modeling. Current projects are focused on elucidating the molecular determinants of protein phase separation, developing novel excipients to prevent protein aggregation, and measuring protein-solvent interactions.

With more than 10 years of experience, Mark is a passionate scientist in the field of biopharmaceutical process development. He worked together with several Top 25 Pharma companies targeting their needs in process development and understanding. Together with his team, he is developing a PAT and QbD software solution for both up and downstream processes. This software utilizes artificial intelligence learning from data and human process models in so called hybrid models to quickly predict critical quality attributes (CQAs) from critical process parameters (CPPs). Hereby, bioprocess development and characterization is accelerated significantly while simultaneously a better process understanding is gathered. From this research project the company Novasign was founded in 2019 offering this unique software solution.

Roya Dayani is Senior Product Manager at Asahi Kasei Bioprocess Europe, where she has more than 10 years of experience in the application of Planova virus removal filters in downstream processing (DSP) of biopharmaceuticals. Currently, she is responsible for pre and after-sales services. In this role, she knows recognizing and understanding customer’s needs is crucial and together with her team, she aims to provide the best customer support at every stage of drug development.

Dr. Bert Devriendt is a postdoctoral fellow at the Laboratory of Immunology, the Faculty of Veterinary Medicine, Ghent University. In 2010 he obtained his PhD in Veterinary Sciences on the interaction between virulence factors of enterotoxigenic E. coli with intestinal epithelial cells and dendritic cells in a piglet model. During his postdoctoral research, he focuses on host-pathogen interactions and how the gained insights might be used to accelerate the development of oral vaccines to prevent enteric diseases. In that context, a strategy was developed to boost uptake of oral vaccine antigens by the gut epithelium via antibody-mediated selective targeting to epithelial aminopeptidase N. Dr. Devriendt also investigates the evasion of immune cell functions by alpha herpes viruses in large animal models.

Gregory Dutra is a PhD student supervised by Professor Alois Jungbauer at BOKU. He is one of the 15 PhD students in the Analytics for Biologics (A4B) project, a Europe-wide innovative training network (ITN). His investigation topic is the continuous separation of recombinant antibodies by non-chromatography methods.

Christophe Egrot is currently in charge of Novasep European technical sales for low pressure batch and continuous systems, as well as columns. His previous positions were at Pall and BioSepra on resin and membrane sales applications, after graduating his MSc in biochemistry and enzymology from Nancy.

 

Maya Fuerstenau-Sharp is Global Manager of Marketing, Regenerative Medicine Applications. In this role she implements the strategic marketing position of Sartorius as a key solutions provider for the advanced therapies market. Maya and her team of consultants facilitate collaborations with global opinion leaders in the cell and gene therapy field to bring new technology solutions to the market. Maya gained her PhD in Biomedicine from University of Regensburg and her MSc in Biotechnology from University of Madison, WI, USA.

Laura Geagan is a Principal Scientist in the Analytical Development group at Sanofi, where she is responsible for analytical method development and validation to support therapeutic protein development. While at Sanofi, one of her main focuses has been the development of cell-based assays for assessing product potency. Her additional area of focus has been method transfer and as Analytical Team Leader for monoclonal antibody programs.

Gerald currently works as Scientific Officer at Novartis Technical Research and Development (TRD) Biologics. Prior to joining Novartis, he gained professional experience in CMC and analytical development during his time at Roche and AbbVie.

Rénald Gilbert is the team leader of Viral Vector Production at the National Research Council Canada (NRC) in Montreal. He is also an adjunct professor in the department of Bioengineering of McGill University. His research interests embrace the optimization of viral vectors for the development of vaccines and for cell and gene therapy applications, as well as the manufacturing process of these complex biologics. R. Gilbert completed his Ph.D. in Biochemistry at McMaster University (Hamilton Ontario) in 1994. Before starting his career as research officer at NRC in 2002, he trained as a postdoctoral fellow in the department of Cell Biology of Weill Cornell Medical College (New York City) and in the department of Neurology in Neurosurgery at the Montreal Neurological Institute of McGill University.

Doctoral thesis on development of a perfusion bioreactor for cells grown on ceramics at Berlin University for Technology; deepening business knowledge for 5 years as a product manager for fertility products; 2016 scientist in up stream process development at Glycotope; promoted to head of bioprocess group in 2018.

Rick led the commercial launch of the Aura and Horizon systems. Rick held similar positions at Unchained Labs, ForteBio, and Molecular Devices. Rick holds degrees from the University of Washington and the University of Maine and has scientific training in tumor immunology and cell biology.

Rainer Hahn holds a PhD in Biotechnology and currently is Associate Professor for Bioprocess Engineering at the Department of Biotechnology at the University of Natural Resources and Life Sciences (BOKU Vienna, Austria). His general field of research is processing of biomolecules from fermentation broths covering a full range of unit operations like centrifugation, homogenization, filtration, ultrafiltration and chromatographic techniques. Research key activities are preparative separations as well as mechanistic modelling and engineering aspects with a special focus on chromatographic separation of proteins and other biomolecules.

Christoph Herwig, bioprocess engineer from RWTH Aachen and obtained a PhD in bioprocess identification at EPFL, Switzerland. From 2008 to 2023, he was full professor for biochemical engineering at the Vienna University of Technology. The research area focused on the development of data science methods for integrated and efficient bioprocess development along PAT and QbD principles for biopharmaceuticals. During his employments in various industries, such as with Lonza, he was deeply involved in the design and commissioning of large chemical and biopharmaceutical facilities. In 2013 he founded the company Exputec, which is now part of Körber Pharma, pioneering data science software solutions for the biopharma life cycle. Here, Christoph currently also acts as senior scientific advisor for Körber. In 2021 he cofounded Fermify and acts as CPO, focusing on providing a fully digitalized production platform for vegan cheese.

Annette Vinther Heydenreich holds a M.Sc. in pharmacy. Annette is specialized in formulation development of biopharmaceutics, initially working with gene delivery (oligonucleotides and DNA vaccines) and later vaccine-adjuvant formulations at small biotech companies. For the last 6 years Annette has been responsible for formulation and drug product development of peptides and protein (including mAbs) for parenteral administration on projects ranging from pre-clinical development to product registration. Annette currently works as a Senior Scientist at Symphogen, which is specialized in the development of antibodies and antibody combinations for the treatment of cancer.

Sophia Hober is Professor of Molecular Biotechnology at KTH, Stockholm, Sweden. The focus of her current research group is development of predictable and robust systems for protein purification and detection by protein design and various selection methodologies. Her key scientific achievements include design and development of gene fusion systems for selective ion-exchange purification and improvements of the alkaline tolerance of protein A for industrial purification of IgG (currently a product sold by GE-Health care). Also, a novel ligand for affinity purification of proteins has been developed that displays a calcium dependent binding, enabling mild elution from the column. Moreover, small bispecific protein domains with ability to strongly and selectively bind to two different proteins recently have been developed for use in diagnostic and therapeutic applications.

Margit Holzer is a biochemical engineer with extensive expertise in the development and implementation of biochemical/technological production processes. She holds a PhD in biotechnology from the University of Natural Resources and Applied Life Sciences in Vienna (Austria). Margit has worked all over Europe for Boehringer Ingelheim and Novasep, she held various positions in R&D, production and manufacturing, quality, and technology, including several executive positions such as Technology Director. Amongst other achievements, she has led a successful FDA inspection on a pharma and biopharma production site as Quality Director. She has been involved in the process development of more than 50 different biopharmaceuticals of different origins (recombinant and non-recombinant cell cultures, yeasts, microorganisms, viruses, plants, and fluids from vertebras). Currently, she works as Scientific Director at Ulysse Consult.

Inês Isidro is Head of the Biosystems and Data Science Group at iBET. She holds a PhD in Bioengineering and her current research combines machine learning, mechanistic modeling, systems biology, and other advanced data analytics platforms to design tailored data-driven strategies to address three major challenges: improving bioprocesses for cell and gene therapy, enabling precision medicine, and supporting drug discovery.

David James is Professor of Bioprocess Engineering in the Department of Chemical and Biological Engineering and Director of the Advanced Biomanufacturing Centre at the University of Sheffield. Previously held academic positions at the Australian Institute of Bioengineering and Nanotechnology, University of Queensland and the University of Kent. Current research and development in collaboration with UK and US bioindustrial partners focuses on engineering cellular manufacture of next generation biological medicines using functional genomics, computational modelling and synthetic biology.

Stuart is the Head of Research at CPI Biologics. He has over 17 years of experience in process development, scale-up, and clinical manufacture for early- to late-phase products. Stuart joined CPI in 2014 to help establish the new National Biologics Manufacturing Centre and build the downstream science technical team. Stuart now leads the research and technical development teams, encompassing upstream, downstream, and analytical development.

Jan Jezek is the Chief Scientific Officer at Arecor Ltd. He has been trained as a biophysical chemist. He was the principal scientist at Insense Ltd, leading the development of a range of novel medical devices from the proof-of-concept all the way to market. During his time at Insense, he and his team developed a novel formulation platform to achieve superior stability of proteins and other biological molecules. His inventions related to protein stabilization led to inception of Arecor Ltd as a separate company focusing on commercialization and further development of the stabilization platform.

Professor Alois Jungbauer received his PhD in Food Technology and Biotechnology from the University of Natural Resources and Life Sciences Vienna, Austria 1986. He serves since then as a professor at the Department of Biotechnology. He teaches Protein Technology and Downstream Processing and Bioprocess Engineering. He also acts as area head and Deputy Director of Research in the Austrian Centre of Industrial Biotechnology. He is currently working in the field of bioengineering of proteins, plasmids and viruses with special focus on expression, downstream processing and characterization of large biomolecules. For more than 10 years he is working on continuous manufacturing of biopharmaceuticals. As a proliferate researcher he has more than 340 publications on recombinant protein production and bioseparation, 17 patents and 12 book contributions and recently a monograph entitled “Protein Chromatography , Process Development and Scale Up”. He is executive editor and co-founder of Biotechnology Journal, and member of editorial boards from numerous journals in the area of biochemical engineering. He acts also a the vice president of research of the European Society of Biochemical Engineering Science.

Alistair heads CMC Development of novel Biopharmaceuticals at Ipsen Biopharm; incorporating Bioprocess, Formulation and Analytical development groups, managing product supply, specification setting & regulatory submissions, through to manufacturing & commercial lifecycle support. Previously, he was Director & Global Head of Analytical Sciences at MedImmune, the Biologics division of AstraZeneca; incorporating Product Characterisation, Potency, Stability, In-Process/Residuals & Quality Control (QC) groups as part of Biopharmaceutical Development. He was also Development lead for Cardiovascular & Metabolic Diseases therapies, CMC project leader and lead for various European Biotechnology Industry-Regulatory forums. Alistair gained his PhD from Cambridge University (with studies on Enzyme Structure & Mechanism with Prof. Sir Alan Fersht at the MRC LMB), and held various previous academic & industrial positions as: Research Scientist at the Geneva University Medical Centre; Senior Scientist at PolyMASC Pharmaceuticals; and Associate Director of Biotechnology-Protein and Immunochemistry at Covance Laboratories.

Dr Knevelman is the Vice President and Head of Process R&D at Oxford Biomedica (OXB), providing specialist expertise in all aspects of process development throughout her eight years with the company. Her main areas of responsibility include early and late phase process development activities encompassing platform process design & optimisation, scale-up, process characterization and technical support in the area of viral vector production/purification development for cell and gene therapy applications. The department works across multi functions to support both OXB’s internal and third party collaborator product development pipeline. Prior to joining OXB, Carol worked for several years for Lonza Biologics both in the UK and US. Carol has an Eng.D in Biochemical Engineering from University College London (UCL).

Daniel Komuczki received a Master of Science in Biotechnology at Wageningen University and a Double Degree (MM.Sc) in Material and Energetic Exploitation of Renewable Raw Materials (NAWARO) from BOKU and the Technical University in Munich (TUM). He is currently a PhD Candidate at BOKU in the group of Alois Jungbauer and embedded in the Marie Sklodowska-Curie ITN “Analytics 4 Biologics” (A4B). His research is focused on fully integrated continuous bioprocessing of recombinant proteins using mammalian cells. Thereby, he emphasizes on the improvement of up- and downstream processes using rapid prototyping by the means of 3D-printing.

I studied Applied Biology at the Slovak University of Agriculture and Biomedicine at University of London where I focused on investigation of cell lipid rafts and their function. I started with GSK as a Senior Scientist in Cellular Technologies group within the Protein & Cellular Sciences department in 2016. My focus has been on the generation and validation of clonal tool cell lines expressing a variety of genes encoding antigens, ion channels and reporter systems in a range of mammalian cell lines to support both, small molecule and biopharmaceutical programs.

Dan Bach Kristensen holds a Ph.D. in biology and B.Sc. degree in chemistry. Dan is specialized in protein chemistry and mass spectrometry, which he initially applied in the field of proteome research in Japan and later in Denmark. For the last 20 years Dan has been working with analytical characterization in the biopharmaceutical industry, on projects ranging from early discovery through to product registration. Clinical indications include bleeding disorders, neutropenia, autoimmune diseases and oncology. Dan currently works as a Scientific Director at Symphogen, which is specialized in the development of antibody-derived formats, including antibody-drug conjugates and bispecific antibodies, for the treatment of cancer and other indications.

Juan Pablo Labbrozzi joined Kiadis Pharma in 2019 as Principal Scientist of Process Development. He is responsible for the global process development activities for the NK cell programs. Dr. Labbrozzi holds a Bachelor’s degree in Chemical Engineering and a Ph.D. degree in Biotechnology from the Universitat Autonoma de Barcelona in Spain.

Dimitrios Lamprou (PhD, MBA) is full professor (Chair) of Biofabrication and Advanced Manufacturing, and Director at MSc Industrial Pharmaceutics at Queen’s University Belfast (QUB). He is also the Chair at United Kingdom and Ireland Controlled Release Society (UKICRS). Dimitrios is the author of over 160 peer-reviewed publications, has over 400 conference abstracts, has given over 160 invited talks in institutions and conferences across the world, and has secured funding more than £5M. Dimitrios has been recognized as world leader in 3D printing & microfluidics. PubMed-based algorithms placed him in the top 0.1% of scholars in the world writing about 3D Printing and in the top 0.07% of scholars in the world writing about microfluidics, in the past 10 years. Moreover, PubMed-based algorithms placed him in the top 0.6% of scholars in the world writing about nanofibers. Dimitrios, has also been named in the Stanford University's list of World's Top 2% Scientists, for several consecutive years, for his research in pharmaceutics and biomedical engineering. He has received a number of awards, including, the Royal Pharmaceutical Society (RPS) Science Award, the Scottish Universities Life Sciences Alliance (SULSA) Leaders Scheme Award, and a Doctor Honoris Causa Award by Semmelweis University (Hungary).

Christine Le Bec joined Sensorion Pharma, a company dedicated to the development of therapies for genetic forms hearing loss, in early 2020 as Head of CMC Gene Therapy. She is responsible of all CMC activities, including process and analytical development, CMC technology transfer to CMOs, manufacturing and supplying of phase I and II clinical trials. Before joining Sensorion Pharma, she worked for more than 20 years at Genethon in the field of Gene Therapy vectors (AAV, Lentivirus, Baculovirus) for rare diseases. She has a strong expertise in the development, qualification, validation of analytical methods for process and product characterization, release testing of gene therapy products and in stability studies. She has also a solid knowledge of International regulations and reviewing CMC documents for clinical trial applications.

Karolina Alicja Les is a Scientist in Purification Process Sciences group in BioPharmaceuticals Development Unit at AstraZeneca. Her primary focus area is design and optimisation of purification processes and their transfer into manufacturing facilities to support early clinical trials. Karolina is also working at the research/development interface providing CMC input to early stage projects. Prior to this, she had worked on half-life modulations of biopharmaceuticals and characterisation of antibody-drug conjugates (ADCs) at Abzena Company. Karolina obtained her PhD from School of Pharmacy of University College London.

Rhys Macown, PhD, is a Lead Scientist in the Technology and Process Innovation team at Cell and Gene Therapy Catapult UK. Rhys earnt a BE(Hons) in chemical and process engineering at University of Canterbury (NZ) before starting his career with a PhD in Biochemical Engineering in Professor Nicolas Szita’s group at University College London. Since joining the Cell and Gene Therapy Catapult in 2014, Rhys has been heavily involved in collaborative and core-funded projects developing pluripotent stem cell-based processes and has played a leading role exploring the 3D expansion of pluripotent stem cells as aggregates. He also has experience in process diagnostics, technology assessment, immunotherapy process development, and automation projects. Rhys now leads the Cell and Gene Therapy Catapult’s Bioprocess Control program developing advanced control and manufacturing strategies for the rapidly expanding cell and gene therapy sector.

As Postdoc in The Novo Nordisk Foundation Center for Biosustainability of Technical University of Denmark, Dr. Martínez-Monge is part of both Quantitative Modelling of Cell Metabolism and CHO-Bioprocess groups of the center. His research is focused in understanding the metabolism of the cells in culture to develop control systems and culture strategies with high productivities. CHO-Bioprocess group works as a translational unit from the scientific research of the center, in order to generate and validate genomic engineered CHO cell lines with properties optimized for industrial production of therapeutic proteins. With Ph.D. in Bioprocess Engineering, Dr. Martínez-Monge has published extensively in the field of mammalian cells-based bioprocesses.

Duarte L. Martins earned a M.Sc. in Biotechnology in 2013 from NOVA University of Lisbon (Portugal). In 2014, he joined Novasep CMO (Belgium), where he developed purification processes for vaccines and gene therapy vectors. In 2020, he completed his Ph.D. on continuous processing and viral inactivation at the University of Natural Resources and Life Sciences in Wien (BOKU)/ACIB and has been focused ?

Dr Paul Matejtschuk leads the Standardisation Science Section at NIBSC, part of the UK’s Medicines & Healthcare products Regulatory Agency, formulating and freeze drying a range of biologicals, many as part of the development of WHO International Standards for bioactivity assignment. He has over 30 years post-doctoral experience in downstream processing and formulation of biologics and has co-supervised a number of PhD students and published and lectured widely on freeze drying and other topics, including editing “Lyophilization/Freeze drying of Pharmaceuticals & Biologicals –New Technologies & Approaches” with Dr Kevin Ward for Springer Press (2019).

Dr. McCarthy is Senior Director, Science and Standards in USP’s Global Biologics Department, where she leads development and maintenance of standards and tools to support quality of medicines and oversees the USP biologics laboratories in the US and India. Her team supports standards and tools across a diverse range of therapies, including vaccines, peptides, cell and gene therapy, monoclonal antibodies, and other protein therapeutics. Prior to joining USP, Diane worked for several small CROs that focused on the use of mass spectrometry for characterization of biologics, host cell proteins, and biomarkers. Dr. McCarthy earned her Ph.D. in Biochemistry from the University of Texas at Austin.

Mark McCoy is currently a Sr. Principal Scientist in the Quantitative Biosciences group at Merck & Co, Inc. where he uses structural biology and biophysical studies to understand details of protein structure, function and behavior. His early discovery work on PD-1-antibody interactions provided the first understanding of Keytruda’s mechanism of action. His most recent research is on understanding details of intermolecular interactions of therapeutic proteins which has discovery applications to developability and design as well as development and manufacturability applications that include formulation and coformulation. Prior to joining Merck, Mark worked at the Wistar Institute, the University of Pennsylvania and at the Sterling-Winthrop Pharmaceutical Research institute. He has a Ph.D. from Princeton University and carried out postdoctoral research at ETH-Zürich.

Jennifer McManus is currently the Head of the School of Physics at the University of Bristol. Her research focusses on phase transitions and assemblies of proteins. She is particularly interested in liquid-liquid phase separation and formulation of therapeutic proteins

Nicolas Mermod is Professor of Biotechnology at the Faculty of Biology and Medicine of the University of Lausanne, and a co-founder of Selexis SA, a biotech company. Nic completed his Ph.D. at the University of Geneva in environmental biotechnology, followed by post-doctoral studies at the University of California at Berkeley, USA, in the laboratory of Professor Robert Tjian. Nic then joined the University of Lausanne as an Assistant Professor of the Swiss National Science Foundation, to become Full Professor and the Director of the Institute of Biotechnology. Nic has gained recognition in the field of gene expression in biotechnology by publishing over 100 papers in peer-reviewed renowned journals and by authoring a number of patents on epigenetic regulatory elements, heterologous gene expression, and cell line engineering.

Dr. Miller is an accomplished biopharmaceutical executive with over 25 years of industry experience, leading multiple CMC functions in the development and commercialization of advanced therapeutics, including cell and gene therapies, inhalation and parenteral formulations, multi-active solid oral dosage forms, and device/combination products. Believing strongly in the criticality of robust product characterization for the success of the regenerative medicine industry, she specializes in method development, validation and transfer, as well as quality control testing and specification strategies, comparability studies, and analytical capability build vs. buy analysis at Dark Horse Consulting.

Ali Mohamed, Ph.D., Vice President, CMC, Immatics US Inc. was formerly the Senior Director of Manufacturing Operations/Manufacturing Development at PCT (now HCATS). Dr. Mohamed has nearly 20 years of experience in process development and GMP manufacturing of regenerative medicine, cell and gene therapy products at various CMOs and clinical-stage companies, including Lonza, Osiris Therapeutics, and AlloCure. The speaker holds a Ph.D. in Molecular Pharmacology from Medical College of Ohio and postdoctoral fellowship in Neuroscience and Neurobiology from Georgetown University.

Massimo Morbidelli received his Laurea in Chemical Engineering at the Politecnico di Milano in 1977, and his PhD in Chemical Engineering at the University of Notre Dame in 1986. After his first appointments as professor at the University of Cagliari (Italy) and then at the Politecnico di Milano, he is, since 1997, Professor of Chemical Reaction Engineering at the Institute for Chemical and Bioengineering at ETH Zurich (Switzerland). His main research interests are in chemical reaction engineering, with particular emphasis on polymer reactions and colloidal engineering. This has evolved over the years in developing new processes for the production of polymer particles, ranging from the micro to the nano scale, exhibiting various types of functionalities and physico-chemical characteristics, including bio compatibility and degradation kinetics. Applications in various areas are considered including drug delivery, composite materials and treatment of oil reservoirs.

Christiane has spent 9 years at the UK medicines regulator MHRA, most recently as the Unit Manager of the Biologicals Unit. At the same time Christiane was a biologicals Senior Quality Assessor and the UK delegate at the EMA committee for advanced therapies (CAT). As UK CAT Rapporteur she was responsible for managing the portfolio of all UK ATMP products (cell and gene therapies). She was also the Rapporteur for the EMA CAT Gene Therapy Guideline, and a drafting group member in all other quality related ATMP drafting groups, including GMP for ATMPs. Prior to joining MHRA, Christiane worked with the UK regulator for the European Tissues and Cells Directive as a quality manager and inspector. Christiane joined Parexel in January 2021 as Vice President Technical for CMC and now works with developers to get cell and gene therapies into the clinic and to market. Since joining Parexel, Christiane has done a significant amount of work within the US regulatory system and can advise on EU, UK and US CMC considerations.

Miroslav grew up in Bulgaria, and before joining Roche in 2017, he spent multiple years working on mass spectrometry-based proteomics approaches, protein biochemistry and lab automation. At the mass spectrometry department in Large Molecule Research (LMR) at Roche Innovation Center Munich (RICM), he leads an MS lab, focused on automation, data management and software. Besides that, his lab and department cover MS analytics and are responsible for characterization of molecules from early research to entry into clinical development. Outside of work, he gets excited about music, technology innovation, gadgets and fast cars.

I am a research scientist who is deeply fascinated by the behaviour of proteins in cells, in living systems and in recombinant engineered systems. The junction of biology, chemistry and physics is of particular interest to me and is manifest in my many collaborative relationships in Europe and the US. I am also a Science Foundation Ireland funded investigator with BEACON, the Bioeconomy Research Centre, that enables me to use my expertise in protein engineering to drive creation of value in the circular economy, ensuring that excellent science creates products and technologies with sustainable properties, and to further enhance the reputation of UCD as Ireland’s number one university.

In the last three years Ozan Ötes worked in the role of a process development engineer in a DSP Development lab at Sanofi-Aventis Germany, contributing to the development of purification processes for biologics. He was involved in the tech transfer for continuous protein A chromatography from Development to GMP at Sanofi Frankfurt. Since January, he is mainly responsible for the tech transfer of biologics from development to GMP production scale. Ozan holds a Master degree in Bioengineering from the KIT (Karlsruhe Institute of Technology), Germany.

Cristina Parola obtained her M.Sc. degree in Medical Biotechnology at the University of Torino, Italy, and subsequently moved to Trondheim, Norway, for an internship in the company GeneSeque. She then completed her Ph.D. at ETH Zurich, in Switzerland, in the Department of Biosystems Science and Engineering located in Basel. During her doctoral studies, she was part of the Laboratory of Systems and Synthetic Immunology of Prof. Sai Reddy, where she worked on developing a mammalian cell platform for antibody engineering. She is now a postdoctoral research scientist at Sanofi, Biologics Research, in the Paris area, where she is working on mammalian display as part of the Enabling Technologies team.

Cristina Peixoto graduated in Applied Chemistry (Branch Biotechnology) New University of Lisbon and she holds a PhD in Engineering Sciences from Instituto de Tecnologia Quimica Biológica (ITQB) from New University of Lisbon. Working in Animal Cell Technology field since 1996, her PhD contributed to the establishment of several scalable purification processes for complex biopharmaceuticals, mainly virus and virus like particles for vaccine and gene therapy. Cristina coordinated several research contract projects with Industrial partners, some of the processes developed are nowadays in GMP for phase I and II and she published over 60 manuscripts in refereed international journals.

Dr. Mary Beth Pelletier is currently the Director of QC Analytical Technology at Biogen in Research Triangle Park, NC, where her global team supports development, optimization, validation, transfer, troubleshooting, and lifecycle maintenance of analytical methods for Biogen’s biologics and gene therapy portfolio from Phase 1 throughout the commercial lifecycle. Mary Beth is also a topic lead for the ICH Expert Working Group for Q2(R2) and Q14 representing BIO. She received her Bachelor’s degree in Chemistry from Northwestern University in Evanston, IL and her Ph.D. in Chemistry from The Scripps Research Institute in La Jolla, CA. Prior to her positions at Biogen, Mary Beth held positions in biologics formulation development and analytical development.

After having studied Biotechnology at the RWTH Aachen, Lisa A. Pieper performed her PhD at the Institute of Cell Biology and Immunology (University of Stuttgart) in cooperation with Boehringer Ingelheim. Lisa joined Boehringer Ingelheim in 2017 as Postdoc in the group of Early Stage Bioprocess Development, focusing on the upstream development of cell culture processes within the context of an integrated state-of-the art process platform for the production of high-quality biologics. Subsequently, she worked as Scientist in the upstream development and assumed project responsibility for the development of New Biological Entities. In 2019, Lisa started as Associate Director in the Contract Manufacturing Business, heading a cell culture laboratory in the department of Bioprocess- and Analytical Development at Boehringer Ingelheim.

Robert Pletzenauer heads Takeda's Gene Therapy Analytics team in Austria. He and his team are responsible for the development of a large part of Takeda's analytical methods in the field of gene therapy as well as their execution to support the ongoing process development. The portfolio of his team includes technologies such as ddPCR, ELISA, AUC, HPLC, CE and in-vitro potency testing. A further area of responsibility is the analytical strategy for gene therapy and thus also such essential chapters as method validation, product characterization and method control strategy.

After studying at ENS Cachan (now Paris-Saclay), Arnaud Poterszman completed his PhD from Strasbourg University and joint the CNRS one year later. He holds a Research Director position and performs his studies in the Department of Integrated Structural Biology at IGBMC, Illkirch France. He has a dual expertise in Structural and Molecular biology with insights on expression technologies and sample preparation. His research is focused on eukaryotic multi-protein complexes involved in transcription regulation and DNA repair by nucleotide excision, particularly, the transcription/DNA repair factor TFIIH and its partners (Orchid 0000-0002-6702-5777)

Sandra Prior joined the National Institute for Biological Standards and Control (NIBSC) a centre of the Medicines & Healthcare Products Regulatory Agency (MHRA, UK) in 2015. She works as a principal scientist on the investigation of structure-function in relation to the safety and efficacy of monoclonal antibody products and on the development of bioassay standards for therapeutic monoclonal antibodies. She also contributes to vaccine immuno-monitoring and clinical assessment activities. She is a member of the European Directorate for the Quality of Medicines and HealthCare (EDQM) monoclonal antibody expert committee and the Official Medicines Control Laboratory (OMCL) monoclonal antibody testing group. She obtained her PhD from the University of Navarra (Spain) and moved to the UK, where she initially worked at NIBSC investigating safety and protective mechanisms of bacterial combination vaccines. In 2010, she joined Lonza Biologics (Cambridge, UK) working on bioactivity and immunogenicity assessment of biotherapeutics. Sandra has over 15 years of experience in applied immunology and in vitro cell-based assay development.

Kamila Pytel is a CMC Team Leader at Gyroscope Therapeutics. Kamila joined the company in October 2017, where she is leading the establishment of analytical development strategies for characterisation of rAAV productions. Prior to joining Gyroscope, Kamila worked at Pfizer Rare Disease Research Unit, the Genetic Medicine Institute in London, as AD Senior Scientist, where she was a part of a research group focused on delivering analytical methodologies for advanced characterisation of rAAV gene therapies. Before joining Pfizer, Kamila trained as a postdoctoral fellow at Imperial College London in the department of National Health & Lung Institute with a focus on development of lentiviral-based gene therapy for treatment of cystic fibrosis. Kamila holds a Ph.D. in Biomedical Sciences (Marie-Curie Project) from Aston University, UK.

Matt is the Associate Director of AAV Production at BridgeBio Gene Therapy, at which he is focused on designing and implementing new strategies for the production and purification of adeno-associated virus. Matt completed his bachelor’s degree in biological sciences at North Carolina State University and his master’s degree in microbiology and cell science at the University of Florida. Prior to BridgeBio, Matt spent time at Precision BioSciences leading a process development team focused on developing upstream and downstream processes for clinical production of AAV. Prior to Precision, Matt worked at Pfizer on AAV purification and the Biomanufacturing Training and Education Center training industry professionals on downstream bioprocessing operations.

Antonio Roldão is the Head of Vaccine Development Laboratory at the Animal Cell Technology Unit (Health & Pharma Division, iBET). Antonio Roldao graduated in Chemical Engineering at the Faculdade de Ciências e Tecnologia da Universidade Nova de Lisboa, and holds a PhD in Engineering and Technology Sciences, Systems Biology from ITQB-NOVA. Current research is driven by the aim to develop novel complex biologics with impact in human and animal Health, and directed to both developed and developing countries. The basis for his work lies on the use and integration of multidisciplinary technologies such as synthetic biology, evolutionary and bioprocess engineering, and bottom-up systems biology to fasten the generation of the products he’s interested in, particularly virus-like particles (VLPs)-based vaccines against infectious and/or neglected diseases (e.g., Influenza, Dengue or haemorrhagic fever). Over the next 5 years he wants to consolidate his research career and continue developing novel bioprocesses for production of vaccines against high-impact (economic- and human-wise) diseases, thus providing solutions to those who most need. CV Highlights: (i) Author of 20 scientific manuscripts in peer-reviewed journals and author/co-author of 3 book chapters (over 850 citations and h-index =13 - Scopus metrics); (ii) Over 20 poster and 15 oral communications (11 invited); (iii) Supervision of 7 PhD students and 1 Junior Researcher; (iv) Best PhD thesis of ITQB-NOVA in 2011; (v) “Investigador FCT 2014” from Fundação para a Ciência e a Tecnologia (Portugal); (vi) PI/co-PI of national and European public/private funded projects (Portuguese Science Foundation - 2, Swedish private foundations – 2); (vii) Project manager of Portuguese (1), Japanese (1), EU (7), pharma/biotech (2) funded projects; (viii) Member of organizing committee of two international scientific meetings and five courses on animal cell technology and protein production; (ix) Reviewer in international scientific journals.

Professor Alan G. Ryder directs the Nanoscale Biophotonics Laboratory (NBL) which is based at the University of Galway (UoG) in Ireland. He has a BSc and PhD (1989) in chemistry from UoG. After a stint as a postdoctoral researcher in UCC, he rejoined UoG in 1997 to work on developing quantitative Raman spectroscopy-based methods for measuring illicit narcotics. In 2003, he formed the NBL which applies photonics and chemometrics technologies to applications in the life and physical sciences. In 2006, he obtained tenure in the School of Chemistry at UoG as senior lecturer and was promoted professor there in 2016. He has two core research areas: Analytical Sciences and Photonics, which cover a wide range of applications. In the Analytical Sciences domain, his main research area is developing of rapid, quantitative, analytical methods for the analysis of complex materials with particular focus on biopharmaceutical manufacturing and cell culture media analysis. He has collaborated with a wide range of biopharmaceutical manufacturing industries since 2004. He has authored more than 100 publications, generated 3 patents, and graduated 23 PhD students.

Florence holds a PhD in Molecular and Cellular Biology from Strasbourg University. She gained considerable experience in product development and regulatory affairs, bringing many of the early cell and gene therapies from the bench to the clinic in the early 2000s, and to approval such as Glybera (first gene therapy in the EU) in 2012. She supported the development of a number of AAV-based gene therapy vectors for various disease areas. From 2014 to 2021 she was Director Global Regulatory Affairs CMC Cell and Gene Therapies, where she worked on the global approval of Kymriah (first CAR T product), Luxturna and Zolgensma. She has worked as regulatory affairs and development expert for several start-ups and venture funds before joining Hookipa Pharma in 2023 to support the late stage development of their arenaviral vectors in various cancer indications.

Lénaïg has 12+ years of experience in the pharma and biotech industry. She started her career as a process engineer at Sanofi Pasteur (Swiftwater, US) working on adjuvants. She has been with Merck for 10+ years. She provides technical support to EMEA customers on single-use bioreactors, single-use and multi-use mixers. Lénaïg holds a Master Degree in Process Engineering from ENSIC (Nancy, France) and a Master Degree in Marine Biotechnology from the University of Nantes (France).
 

Dr. Stefan R. Schmidt, MBA, is currently CEO at evitria AG, a company dedicated to antibody discovery services in Zürich, after leading operations at BioAtrium AG, a joint venture of Lonza and Sanofi in Visp, Switzerland, as COO. Previously he held the position as CSO and other senior executive roles at Rentschler Biopharma, Germany, with overall responsibilities for biologics development and manufacturing. Before that, he was CSO at ERA Biotech in Barcelona, Spain, directing the company’s R&D efforts based on fusion proteins. Prior to that, he worked at AstraZeneca in Sweden where he led the unit of Protein Sciences within Global Protein Science & Supply as Associate Director. He started his leadership career 25 years ago at Biotech companies in Munich, Germany, where he built up protein biochemistry teams for Connex and GPC-Biotech. He holds a PhD in Biochemistry from the Julius Maximilians University in Wuerzburg, Germany and an MBA from the University in Gävle, Sweden.

Enda Shevlin joined Cellectis in May 2017 as Project Leader within the Process Development group in Paris. He completed his undergraduate degree and Ph.D. at Trinity College Dublin and Maynooth University before moving to New York, where he developed and published novel strategies for improving CAR T cell efficacy and detection as part of his postdoctoral studies at Weill Cornell. Today, his work at Cellectis centers around designing, testing, and implementing improved process technologies and strategies within Cellectis’ UCART manufacturing platform.

Ricardo Silva received his PhD degree in Chemical and Biochemical Engineering from New University of Lisbon in 2013. His studies focused on the development and optimization of countercurrent adsorption processes for purification of (bio)pharmaceutical products. Since 2014 he is a senior scientist at Animal Cell Technology Unit in iBET, pursuing the development of continuous purification processes and identification of new purification strategies for vaccines, gene therapy vectors and cell-based products.

Andrew has over 30 years’ design and operational experience in the biopharmaceutical industry, with direct responsibility for manufacturing, logistics, maintenance and capital programme management. He has developed Biopharm Services into a leading provider of bioprocess modelling and knowledge management tools that support bioprocess innovation. The focus of his work is in the understanding the impact of innovative technologies on biomanufacturing with focus on single use systems and continuous processing. Prior to Biopharm Services, Andrew was Director of Engineering and Logistics at Lonza Biologics and holds an MSc in Biochemical Engineering from UCL. He was a finalist in “The Manufacturing Processing Thought Leader of the Decade” category at the 2012 BioProcess International Awards and in 2014 was appointed a Fellow of the Royal Academy of Engineering in the UK.

Dr. Michael Sokolov is co-founder and COO of DataHow AG, a spin-off company from ETH Zurich specialized on process data analytics and modeling with a particular focus on the biopharmaceutical and chemical domains. He also holds a lecturer position for statistics for chemical engineers at ETH.

As Principal Scientist of Wyatt's Marketing Department, Dr. Some is responsible for conveying to customers the manifold benefits of our unique products and services, as well as learning about specific needs and opportunities expressed by our customers. He believes that our success can only be achieved through that of our users. He investigates techniques for characterization of macromolecular interactions, contributing to the development of new instruments and applications.

David has >15 years of experience in biopharmaceutical R&D supporting many pre-clinical and clinical development programs for therapeutic proteins. David joined Ipsen in 2016 where he leads the Characterisation group as part of Biologics Pharmaceutical Development. David formerly worked at MedImmune/AstraZeneca both in the UK and the US. David’s analytical responsibilities and interests span from protein engineering (developability by design) to bioprocess/formulation development and manufacturing. David gained his BSc in Biochemistry/Biotechnology from the University of Sheffield, UK.

Lars Stöckl joined Glycotope GmbH in 2005. As a cell and protein biochemist, he first was responsible for the development of novel GlycoExpress cell lines, which resulted in MabExpress, a cell line glycoengineered for the production of higher active antibodies. Since 2007, he is Project Manager of one of Glycotope’s most advanced pipeline project, FSH-GEX, and since January 2020, he is heading the service division of Glycotope.

University Professor at the Department of Biotechnology (BOKU), Head of the Institute of Bioprocess Science and Engineering, Head of working group fermentation technology and principal investigator in the Austrian Center of Industrial Biotechnology (ACIB). The working group has established an integrated systems approach for bioprocess development and is focused on the implementation of PAT and QbD concepts in bioprocessing and rational host cell design. CHO, E. coli, insect cells and vero cell lines are used as expression systems for production of a representative set of biopharmaceuticals (mABs, Fabs, scFvs, VLPs, viruses, DNA.

Dr Taylor has a PhD in Biochemistry and more than 25 years experience in novel high value life-science instrumentation. Prior to joining Solentim ten years ago, Dr Taylor was Commercial Director at Genetix PLC, responsible for the ClonePix FL designed for selection and isolation of high value monoclonal antibody-producing clones.

Dr. Shahid Uddin is currently Director of Drug Product, Formulation & Stability within the CMC department at Immunocore. His team is responsible for bringing research candidates into clinic and commercialization. Technology is focused around developing ImmTAC as therapeutic agents for different disease models. Prior to this he held the position of Head of Formulation at MedImmune (AstraZeneca) where he supported the biologics portfolio covering Monoclonal antibodies, Peptides, bispecifics, and other proteins. He has extensive experience in pre-formulation/formulation, forced degradation, delivery of biologics both for early and late-stage programs.

Rico is currently performing his Ph.D. in cell line development and engineering at the Mannheim University of Applied sciences in cooperation with Octapharma Biopharmaceuticals and the university of Heidelberg. His aim is to alter protein post-translational modifications generated by the HEK 293-F cell line in order to improve pharmacokinetics of recombinant protein drugs produced by it. Before his Ph.D. he obtained a MSc of biotechnology at the Mannheim University of Applied Sciences and worked in the Cell Line Development group of Octapharma.

Bjørn Voldborg has more than 20 years of experience working with recombinant protein expression from both academic and industrial settings. Bjørn was team leader in the biotech company Pharmexa A/S, responsible for molecular cloning and expression of protein-based drug candidates. From this, he went to the NNF Center for Protein Research at the University of Copenhagen as Head of the Protein Production Unit, and, since 2012, Bjørn has been heading the CHO Cell Line Engineering project dedicated to the engineering of improved protein production cell factories, and since 2021 he has been heading the Cell Line and Protein Production in the National Biologics Facility at the Technical University of Denmark.

Dr. Moritz von Stosch is a thought leader in the area of hybrid modeling for bioprocess development and manufacturing. He is the co-author of more than 40 scientific publications, including the book “Hybrid Modelling in Process Industries.” He is the Chief Innovation Officer at DataHow AG, developing novel approaches for accelerated process development and Managing Director of DataHow LDA. Prior to joining DataHow, Moritz led the Process Systems Biology & Engineering Centre of Excellence at GSK Vaccines, for which he received an Innovation Performance and Trust award and was nominated a change catalyst. He lectured at Newcastle University (England), holds a PhD in Biochemical Engineering from University of Porto (Portugal), and received a Dipl.Ing. in Chemical Engineering from RWTH Aachen University (Germany).

Dr. Warren has 30 years of experience in the development, manufacturing, and commercialization of gene therapy viral vectors and live viral vaccines, with applied focus on bioprocess development and CMC Development Strategy. At Ultragenyx, he leads Global CMC Development across a broad pipeline of products including small molecules, Biologics, ASOs, and Gene Therapy. Before coming to Ultragenyx Jim held senior CMC leadership positions at Homology Medicines, bluebird bio, Shire, and Merck & Co., leading process development and manufacturing teams responsible for development of several clinical candidates as well as the licensure of RotaTeq, Varivax, ProQuad, and Zostavax. Dr. Warren holds BS/MS degrees in Biotechnology from William Paterson University and a PhD in Molecular and Cellular Biology from Lehigh University.

After completing his studies in Pharmaceutical Biotechnology at the University of Ulm (MSc), Johannes Wirth joined Rentschler in 2017 as a scientist and is currently working the department of Process Science. The department is engaged in all aspects of modern bioprocess development with a focus on implementing new technologies and approaches to improve upstream bioprocesses.

 

​

​

Dr. Yan-ping Yang received PhD in Biochemistry from the University of Missouri-Columbia, USA, and has 28 years of experiences in vaccine research and development with Sanofi Pasteur. She has been with the R&D department since 1989, involved in various bacterial and viral vaccine development projects with numerous patents, publications and presentations. Over the years Yan-ping has had increasing responsibilities within the company and currently, is the Head of Bioprocess Research & Development North America, overseeing a department of ~100 staff in its efforts to develop manufacturing processes to provide materials for preclinical and clinical studies up to phase III.