All Conference Participants Welcome
1:45 Chairperson’s Opening Remarks
Li Shi, Ph.D., Shanghai Zerun Biotechnology, PR China
1:50 CHO Cell History and CHO Genetics & Genomics for Manufacturing – Insights, Questions, Opportunities
Florian M. Wurm, Ph.D., Professor, Biotechnology, Swiss Federal Institute of Technology Lausanne (EPFL) and Founder, CSO, ExcellGene SA, Switzerland
CHO cells have been used in culture for more than 50 years. Only “recently” from the 80s on they have become the most successful manufacturing technology for recombinant proteins. This talk will cover the earlier and later history of these cells, and will discuss their unique genetics, their phenotypical adaptability and the reasons for their overall popularity and productivity. In addition, the complexities of immortalized cells as production hosts will be discussed and opportunities and challenges to use genomics data for their improvement will be presented.
2:30 Evolution of ADC by Design - A Journey of Protein Medicinal Chemistry Using an Expended Genetic Code
Peter Kiener, Ph.D., CSO, Ambrx USA and Feng Tian, Ph.D., Director, EuCODE Technology and Head, Ambrx China
Technologies essential to ADC development have evolved - from polyclonal murine antibodies to fully human monoclonal antibodies; from non-specific conjugation toward site-specific conjugation. Ambrx is using its proprietary Protein Medicinal ChemistryTM platform to create novel site-specific combinations of antibody, linker, and drug, to optimize the therapeutic potential of ADCs. Furthermore, we are using an innovative business model - partnering with Zhejiang Medicines Co. and Wuxi - to develop our first clinical candidate in China. This presentation will provide a summary of our recent experiences.
FIRST PUBLIC ANNOUNCEMENT
3:10 Developing the First Fully Human mAb in China Using the OmniRat™ Transgenic Technology
Chris Chen, Ph.D., Senior Vice President and CTO, Biologics Services, Wuxi Apptec, PR China
Developing fully human mAbs using transgenic animals has emerged as a dominant technology for therapeutic monoclonal antibodies. However, this technology has not been applied for mAb discovery in China. By collaborating with Open Monoclonal Technology Inc, we have successfully developed the first fully human mAb using the OmniRat™ technology. This case study will highlight the entire mAb discovery process from antigen generation to identification of mAb candidate for cell line development. Technical challenges and lessons learned will be discussed.
3:45 Refreshment Break in the Exhibit Hall with Poster Viewing
4:15 Breakout Discussions
Breakout discussions are facilitated, small-group discussions which encourage interactive participation leading to problem-solving and future collaborations around focused topics. Attendees will discuss novel technologies, complex challenges or exciting ideas ranging from protein & antibody research to scaling up and CMC issues. Each breakout discussion will be facilitated by a moderator with attendees from diverse disciplines sharing a common interest in a specific discussion topic.
Discussion topics include:
Why Is Cell Line and Process Development for Recombinant Cells An Individualistic Exercise?
Moderator: Florian Wurm, Ph.D., Professor, Biotechnology, Swiss Federal Institute of Technology Lausanne (EPFL) & Founder, CSO, ExcellGene SA, Switzerland
• Differences between a diploid cell strain and an immortalized cell population
• Impacts of population dynamics in immmortalized cell populations
• Gene-insertions into a dynamic genome - how much do we not know
• Platform technologies for cell culture - truths, mysteries and lies
Single Cell Cloning - Hazards and Opportunities
Moderator: Maria J de Jesus, Ph.D., COO, ExcellGene SA, Switzerland
• Cloning - exercises in "bottlenecking" cell populations
• What is a clone? What is a clonal population?
• Increased stability by cloning?
• More clones - more opportunities for finding the super producer?
Analytical Characterization for Product Comparability
Moderator: Daotian Fu, Ph.D., Executive Vice President, Livzon Mabpharm, Inc., PR China
Trends in European Phamacopoia
Moderator: Matthias Germer, Ph.D., Senior Director, Preclinical Research, Biotest AG, Germany
• 3R principle
• Novel Methods
• Hot Topics
Cell-Free Production of Membrane Proteins and Other Difficult Targets
Moderator: Frank Bernhard, Ph.D., Lab Head, Institute of Biophysical Chemistry, Goethe University Frankfurt, Germany
• Getting started: Establishing cell-free expression technologies
• Cell-free extract sources: What makes the difference?
• Variation is the standard: Modification of cell-free expression reactions
• Challenging targets: Integral membrane proteins & complexes
• Current perspectives: Emerging systems and applications
Collaboration between Biopharmaceutical Industries in China and Foreign Academic Scientists
Moderator: Lei Zheng, M.D., Ph.D., Assistant Professor, Oncology, John Hopkins University School of Medicine, USA
• What are the potential areas and opportunities for the collaboration between biopharmaceutical Industries in China and Foreign Academic Scientists?
• What are the challenges for the collaboration between Biopharmaceutical Industries in China and Foreign Academic Scientists?
• What are the regulatory barriers for the foreign academic scientists to bring their intellectual properties(IPs) to the industries in China for further development?
• What may help biopharmaceutical industries in China attract foreign academic scientists to bring their IPs to China?
• What may help foreign academic scientists to identify an industry partner in China for the business development of their IPs?
• Are there any opportunity for Biopharmaceutical Industries in China to sponsor the research conducted by Foreign Academic Scientists?
Engineered Antibody Domains and Scaffolds
Moderator: Dimitrov Dimiter, Ph.D., Senior Investigator, Center for Cancer Research, NCI, National Institutes of Health, USA
• Engineered antibody domains and fragments as scaffolds
• Engineered antibody domains as binders
• Engineered antibody fragments as binders
Development of Novel Biotherapeutics
Moderator: Weiming Xu, CEO, Molecular Biology, London Biotech Ltd., United Kingdom
• In vitro antibody generation technologies: display technologies, peptide display
• In vivo antibody generation technologies: chimeric, primatized,
• nanobodies, bispecific ,deimmunized, human engineered,
• humanized, XenoMouse, developing humanized anti-PCSK9 antibody
• Antibody conjugation: Qdot, peptide, viral protein, N-linked glycan
Antibody-Drug Conjugates: CMC and Manufacturing Strategies
Moderator: Shan Jiang, Ph.D., Director, Formulation and Fill/Finish, Seattle Genetics, Inc., USA
• Product quality attributes for ADC: release, stability testing, and characterizations;
• Lessons learned from early generation ADCs: Improving and understanding the drug linker technology
• Formulation challenges of ADCs: physical instabilities and chemical instabilities
• Managing ADC manufacturing complexity through appropriate facility designs: drug substance and drug product
How to Select The Best Expression System?
Moderator: Ning Gao, Senior Scientist, AstraZeneca R&D Boston, USA
• E. coli vs. Baculovirus
• Baculovirus vs. mammalian cell
• E. coli vs. cell free system
• Co-expression with a chaperone and expression in the presence of a ligand
Supply Chain Challenges in China’s Biopharmaceutical Industry
Moderator: H Fai Poon, Ph.D., Director, Cell Culture, Hisun Pharmaceuticals, PR China
• What are the top 5 challenges in China's Biopharamceutical Industry
• How to over come these challenges?
• How to balance cost and quality via supply chain
Manufacturing Compliance – Dos and Don’ts for Manufacturing in Asia
Moderator: Scott Wheelwright, Ph.D., Principal Consultant, Complya Asia Co., Ltd., PR China
• Asia provides opportunities for sourcing raw materials, drug substance, drug product and testing
• What are the biggest risks for sourcing in Asia?
• What strategies work best to mitigate these risks?
• Where are the best opportunities?
5:15 Close of Conference Day Two