Immunogenicity Programs: Not Just Another Box to Check (2010)

In association with:

Overview of workshop:

Biopharmaceutical products hold great promise in therapeutics because of their excellent targeting ability. This advantage is tempered with the danger of inducing an unwanted immune response in patients. This workshop is designed to provide a thorough understanding of the scientific and regulatory expectations to detect and characterize antibodies to therapeutic proteins. We will start with describing the biological mechanism responsible for immunogenicity and interpret the recommendations of major regulatory and industry documents. The workshop continues by demonstrating logical pathways to select, standardize and validate correct immunogenicity methods then execute sample analysis. The final section reviews strategic paths to evaluate risk and manage immunogenicity issues to not only be successful in the clinic but also throughout the entire life cycle of a drug. Case studies will be used throughout the workshop to demonstrate the various theoretical points.

Upon completion of this workshop, attendees should be able to:

• Comprehend the biological basis for the immunogenic response to protein drugs
• Comply with the current regulatory and industry expectations on immunogenicity testing
• Develop and validate appropriate methods to detect and characterize antibodies
• Correctly interpret immunogenicity data from pre-clinical and clinical studies
• Contribute strategically to the immunogenicity Risk Management Plan throughout the life cycle of the drug
   

About the workshop host:

Ana T. Menendez, Ph.D., is Senior Director of Biotechnology at Catalent where she implemented the following services to support the biopharmaceutical industry: potency bioassays, PK/PD, immunogenicity and viral clearance. Dr. Menendez previously worked at Bristol-Myers Squibb where she headed the Cancer Cell Biology Department. From 1982 to 1995 she pioneered monoclonal antibody technology at Wyeth and was responsible for all the immunoassays and in vitro bioassays for Mylotarg, an anticancer monoclonal antibody - toxin conjugate that was approved in 2000. Dr. Menendez is an international speaker and course instructor on Immunogenicity and Bioassay Method Development and Validation.
 

About Catalent:

Catalent Pharma Solutions is a leading, global provider of advanced technologies as well as development, manufacturing and packaging services for pharmaceutical and biotechnological companies. Catalent offers analytical, bioanalytical and immunogenicity testing in addition to mammalian cell gene expression (GPEx®), protein manufacturing, method validation, stability studies, formulation development and regulatory consulting.

http://www.catalent.com