Utilizing Expertise And Experience For Successful Downstream Processing

By Andrew Griffiths, Senior Specialist, MS&T, Emergent BioSolutions

When selecting a contract development and manufacturing organization (CDMO) partner for drug substance manufacturing, it is important to recognize that the CDMO’s goal is to assist you in optimizing processes, maximizing productivity, and providing flexible systems and solutions to better ensure the integrity of your product during downstream processing.

In biopharmaceutical drug manufacturing, safety, identity, strength, purity, and quality are essential to safeguarding product integrity. To this end, optimizing purification and filtration during downstream processing are paramount and typically incorporate several steps. Proper isolation of the molecule of interest from extraneous constituents before formulation promotes favorable processing of the desired therapeutic or vaccine.

CDMOs can and do use a variety of approaches for purification and filtration during drug substance manufacturing. Working with a CDMO that can impart extensive expertise to the numerous methods common to downstream drug substance manufacturing ultimately can help you achieve the most positive outcomes for your process.