From The Stage

Biologics Market Growth Demands Quality Science that Can Keep Pace

Jim Datin
Posted by Jim Datin / / CRO Selection, Industry Update

It is anticipated that biologics will comprise 50% of the top 100 drugs by 2021. But, given the structural complexities of large molecule drugs, adherence to stringent quality standards will be a necessary part of effectively bringing these innovations to market. We discuss why it will be essential for pharma and biotech companies to align with outsourced partners that can deliver the quality science large molecule bioanalysis demands.

Determining the Efficacy of Biologics Using Potency Assays Under Good Manufacturing Practice Regulations

Dr. Afshin Safavi
Posted by Dr. Afshin Safavi / / Cell-Based Assays, CRO Selection

Cell-based potency assays, the central tool used to measure drug efficacy during potency testing, allow scientists to see how a particular dose of a drug will react in a given biological system. We discuss how an ideal CRO partner should approach potency assay design and validation under GMP.