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By Eliza Fung, Jonathan Haulenbeek, and Jamie Moore

Eliza Fung-finalJonathan Haulenbeek-finalJamie Moore-finalIn recent years, the development of biologics is the fastest growing segment of the pharmaceutical industry. Biologics are quite complex and heterogeneous compared to small molecules. As such, appropriate testing is required to be developed to monitor the quality attributes of the biological products during the drug development life-cycle, which supports chemistry, manufacturing, and controls activities including release and stability testing for drug substance and drug product. Quality attributes include those that define the identity, strength, potency, and purity of the biological product as indicated on the Certificate of Analysis (COA). Due to the diversity of different classes of biological products (e.g., monoclonal antibodies, cytokines, growth factors, antibody-drug conjugates (ADCs), fixed dose combination of multiple biologics), different types of analytical testing are needed to properly characterize the drug substances and drug products. Some examples include characterization of size variant, charge variants, bioassays for potency evaluation, free PEG level for pegylated therapeutic proteins, free drug, and drug distribution for ADCs.

Another interesting aspect to consider is that technology platforms continue to evolve. With the availability of emerging technologies that can provide better biophysical/physiochemical characterization of biologics (therapeutics or critical reagents), special consideration is needed to ensure appropriate technologies are used and specifications are adapted, as appropriate. In addition, dialogue with health authorities may be warranted to solicit feedback on testing strategies and specifications that will be applied at each stage of drug development.

As the biopharmaceutical industry has evolved, many companies employ platform strategies to support early phase development. The successful implementation of platform strategies depends on the amount of in-house data or literature data that are available for the class of biologics. Currently, different companies apply different approaches to platform strategies, with varying degrees of success.

There will be a roundtable discussion at the 2014 AAPS Annual Meeting and Exposition which aims to foster an open dialogue between pharmaceutical scientists and health authorities on analytical tools to characterize the quality attributes and set specifications for biologics (e.g., mAb, fixed dose combination), with emphasis on the challenges encountered as programs move through the drug development life-cycle. The discussions should provide an opportunity for pharmaceutical scientists to learn from each other’s experiences.

Come and be a part of the dialogue at the 2014 AAPS Annual Meeting in San Diego on Thursday, November 6, 9 am—11 am.

Eliza Fung, Ph.D., is currently Senior Research Investigator from the Department of Analytical and Bioanalytical Development at Bristol-Myer Squibb (BMS) in Princeton, NJ. Fung received her B.S. (1st Hon.) in Chemistry (1993) from the Chinese University of Hong Kong, her Ph.D. in Analytical Chemistry (1998) from Iowa State University, and is a member of the Honor Society of Phi Kappa Phi. She serves as the Secretary/Treasurer of AAPS’ APQ Section.
Jonathan Haulenbeek, Ph.D. is a research investigator in analytical and bioanalytical development at Bristol-Myers Squibb Company (BMS) in Princeton, NJ. He received a B.S. degree in chemistry and cell and molecular biology from Long Island University and a Ph.D. degree in chemistry from Drexel University.
Jamie Moore, Ph.D., is a Director leading the Late Stage Pharmaceutical Development at Genentech, responsible for developing formulations to support Ph3 and commercialization, and providing support for Commercial Products including tech transfers, version changes, and investigations.