There are several drivers behind the need for process improvements and innovation in the CMC bioassay space. Most organizations experience a constant pressure to reduce cost, increase throughput, and be more efficient. Sometimes, there is a need or a strong desire to improve a bioassay by making it more accurate, precise, or robust. And in some cases, bioassay innovation is driven by the drug itself: for example, by the need to adequately capture increasingly complex modes of action in simple model systems, characterize specific attributes, or the requirement to distinguish the effects of different drug molecules. At the same time, improvements and innovations need to be designed and executed so as to ensure data integrity, using instrumentation and procedures that are transferrable to a QC testing lab. Navigating these different needs and constraints can be challenging. In this session, we will focus on how different organizations have approached and balanced these challenges.

Speakers:

Nailing Zhang, CDER, FDA

Expectations on Potency Assays for Antibody-based Novel Modalities - A Regulatory Perspective

Tillman Polonio-Vallon, Abbvie, Inc.

Simulation Tool to Optimize and Validate Bioassay Control Strategy

Patrick Wong, Bristol-Myers Squibb Company

Novel Fluorescence-Linked Immunosorbent Assay to Evaluate Bispecific Antibody Potency

Daniel Markx, Boehringer Ingelheim Pharma GmbH & Co. KG

Real-time Bioassay Analysis for Potency Determination using xCelligence

Patrick Wong

Appearances

Workshop Session IV: Process Improvements/Innovation in Bioassays

Session Chairs

Speakers