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.
The new Octet RED96e system is an enhancement to our industry-leading Octet RED96 instrument with additional capabilities to expand the number and types of samples that can be assayed, increasing access to data that can reduce the risk in bringing a drug candidate to market