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.
Our team recently attended the 14th Annual PEGS Summit to participate in discussions around advancements in biotherapeutic protein drug development and how they impact the work we do with large molecule biologics. From improving efficacy of CAR-T cell therapies to managing the challenges of immunogenicity testing, we’ve summarized the most compelling insights we gained at this year’s event.
BioAgilytix recently had the opportunity to work on a particularly difficult clinical phase anti-drug antibody (ADA) assessment for an innovative PEGylated drug therapy designed to treat a serious chronic condition. Jeff Sailstad, our USA Chief Scientific Officer, explains how our team approached the unique challenges of this assessment.