Speakers

Presentation Title: Outsourcing Antibody and Antibody-Drug-Conjugates Development and Manufacturing: When, Who, and How?

Abstract: Outsourcing partnerships for CMC development and manufacturing of biologics are of strategic importance for many companies esp. with innovative pipelines and employing new technologies. Antibody-drug conjugates (ADCs), linking small molecule highly potent drugs to antibodies for efficacy and targeting, offer new treatment options esp. in oncology, while the complexity of ADCs makes their CMC development and manufacturing challenging. Especially in determining its clinical as well as commercial manufacturing set-up, companies must consider what best suits their needs and decide between building internal capabilities and outsourcing. The presentation will review the benefits and challenges, best practices, and how to avoid pitfalls when producing in-house and/or outsourcing the manufacture of antibodies and ADCs to external partners. Right expertise and fruitful CDMO partnerships allow to avoid or overcome development, supply and quality issues, ultimately leading to timely launch readiness.