Element

Articles

This white paper discusses developing optimal platform analytical methods with partner CDMOs for effective process impurities clearance in biological drug substances.

Process Impurities Clearance in Biologics


Element’s Senior Director of Biologics, Dr. Khanh Ngo Courtney, provides insight into the nature of the relationship between biopharmaceutical companies and CDMOs, including the critical role that CDMO partners serve in the development and streamlining of regulatory strategies. Evolving needs of the rapidly growing biologics market, particularly in advanced therapeutics such as gene and cell therapies, will be discussed within the framework of how CDMOs can ensure flexible, integrated solutions and service offerings to meet these ever-changing needs. Come away with a greater understanding of the implementation and use of platform methods as a foundation for a phase-appropriate large molecule CMC strategy.

