The Future of Monoclonal Antibody Biotherapeutics Production and Development

Organizers: Keith Canada, Boehringer Ingelheim; Gordon Moore, Centocor, Johnson & Johnson; Janet Kerr, Merck

After a somewhat slow start monoclonal antibodies have evolved into a beneficial and profitable group of protein therapeutics. Their further development is still hampered by several issues including immunogenicity, cost of production, route of administration, and patient compliance. To address these issues a number of innovative technical efforts are being developed including protein engineering, novel expression systems, high-throughput platforms, improved process techniques, new formulations and delivery methods. The enabling of these technologies in production and development will allow monoclonal antibody therapeutics to keep gaining market share and continue to improve patient quality of life.

8:30 – 9:00 AM
Registration & Continental Breakfast

9:00 – 9:10 AM
Introduction
Keith Canada, PhD
Boehringer Ingelheim Pharmaceuticals

9:10 – 10:00 AM
Keynote Address: Engineering Antibodies for Cancer Therapy
Louis M. Weiner, MD
Fox Chase Cancer Center

10:00 –10:20 AM
Refreshments

10:20 – 11:05 AM
Monoclonal Antibody Pharmacokinetics
Joseph Balthasar, PhD
University of Buffalo

11:05 – 11:50 AM
Molecular Mechanisms of IgG Homeostasis: Implications for the In Vivo Transport and Distribution of IgG
E. Sally Ward, PhD
University of Texas Southwestern Medical Center

11:50 AM – 12:35 PM
Impact of Fc Glycans on Antibody Functions and Stability
T. Shantha Raju, PhD
Centocor

12:35 – 1:30 PM
Luncheon

1:30 – 2:15 PM Increasing Speed and Throughput of Recombinant Antibodies through Preclinical and Clinical Development
Kevin Bailey, PhD
Regeneron Pharmaceuticals

2:15 – 3:00 PM
A Systems Approach to the Creation of Cell Lines and Bioprocesses for the Clinical/Commercial Production of Therapeutic Monoclonal Antibodies
Gordon Moore, PhD
Centocor

3:00 – 3:20 PM
Refreshments

3:20 – 4:05 PM
Challenges for the Fast Track Development of Biopharmaceutical Therapeutics
Patrick Garidel, PhD
Boehringer Ingelheim Pharmaceuticals

4:05 – 4:50 PM
Transitioning Monoclonal Antibody Candidates to the Clinic: Nonclinical Safety Assessment
Paul Andrews, PhD
Patrys Pty Limited

4:50 – 5:00 PM
Closing Remarks
Janet Kerr, PhD
Merck Research Laboratories

Abstracts

Engineering Antibodies for Cancer Therapy
Louis M. Weiner, MD
Fox Chase Cancer Center

Monoclonal antibodies have emerged as useful therapeutic vehicles for a variety of malignancies. Antibody size, valence and human composition can be effectively manipulated to obtain tumor targeting that is customized for the intended therapeutic applications. We have conducted a series of studies that demonstrate the powerful influences of intrinsic binding site affinity on selective tumor targeting, and on selected anti-tumor mechanisms such as antibody-dependent cellular cytotoxicity (ADCC). These observations have important implications for the design of therapeutic antibodies.

It is now evident that antibody structures can be optimized to improve antibody targeting and the capacity to manipulate target cell and effector cell signaling, and this will improve the efficacy of antibody-based cancer therapy.