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
Ho Sung Cho, Ph.D., CTO, 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:
- Making Therapeutic Antibodies against Multispan Transmembrane Proteins
- Development of Novel Biotherapeutics
- Development of Engineered Protein Scaffolds
- Antibody Engineering to Make Effective ADCs
- Bispecific Constructs and Their Future Developments
- Collaboration between Biopharmaceutical Industries in China and Foreign Academic Scientists
- Cell-Free Production of Membrane Proteins and Other Difficult Targets
- New Expression Platforms for Manufacturing Cell Line Development
- Setting Up DAR Specifications for Clinical Production
- The Future of Biotherapeutic Stabilization: Protein Engineering or Formulation?
- Supply Chain Challenges
- ADC - CMC and Manufacturing Strategy
- Establishing Own Manufacturing Facilities vs CMOs – What is the
- Minor Variant Characterization and Mass Spec Application in China’s Biotech Industries
5:15 Close of Conference Day Two