CaSSS Bioassays 2021: Scientific Approaches & Regulatory Strategies

CaSSS Bioassays 2021: Scientific Approaches & Regulatory Strategies

Dates: April 19, 2021 - April 23, 2021

Location: Virtual

Recombinant protein and biological products are becoming more complex and the evolving technology including patient-centric, gene- and cell-based therapeutics are changing the landscape for bioassays. The bioassay is a critical element of the control system for this class of therapeutics and is often required to support lot release and stability testing, as well as comparability and characterization studies. Developing robust, QC-suitable bioassays that reflect all the potential mechanisms of action can be challenging, particularly for novel biologic therapeutics or those that incorporate multiple active sites. This is no easy task! As such, bioassays must be scientifically relevant and reflect the mechanism of action. The CASSS Bioassays Symposium provides attendees an interesting view of this exciting class of analytics, along with current technical and regulatory perspectives in an interactive atmosphere.

Biologics Consulting consultants will be attending this virtual event.

2021-04-19 2021-04-23 Recombinant protein and biological products are becoming more complex and the evolving technology including patient-centric, gene- and cell-based therapeutics are changing the landscape for bioassays. The bioassay is a critical element of the control system for this class of therapeutics and is often required to support lot release and stability testing, as well as comparability and characterization studies. Developing robust, QC-suitable bioassays that reflect all the potential mechanisms of action can be challenging, particularly for novel biologic therapeutics or those that incorporate multiple active sites. This is no easy task! As such, bioassays must be scientifically relevant and reflect the mechanism of action. The CASSS Bioassays Symposium provides attendees an interesting view of this exciting class of analytics, along with current technical and regulatory perspectives in an interactive atmosphere. Biologics Consulting consultants will be attending this virtual event. America/New_York CaSSS Bioassays 2021: Scientific Approaches & Regulatory Strategies Virtual