How is the increasing complexity of modalities reshaping CDMO differentiation and specialization strategies?

“As drug pipelines expand beyond conventional small molecules and standard biologics, CDMOs are being pushed to define themselves through narrower, higher-value areas of expertise. Modalities such as HPAPIs, ADCs, bispecific antibodies, cell and gene therapies, and RNA-based medicines do not rely on a common manufacturing playbook; each brings its own process requirements, control strategies, analytical challenges, and facility demands. In the past, service providers could position themselves primarily on the basis of chemical versus biological manufacturing. That distinction is becoming much less useful because many emerging therapies sit at the intersection of both. ADCs are a clear example: they require biologics manufacturing capabilities alongside potent compound handling, linker chemistry, bioconjugation expertise, and advanced characterization techniques.”

In this roundtable article in Pharma’s Almanac, William Sanders, Veranova’s Global VP, Chemical Development Operations, discusses the manufacturing challenges presented by new pharmaceutical modalities.