Biologics are a unique class of pharmaceuticals with many complex requirements when it comes to developing, manufacturing, packaging, storage and distribution. The often strict thermal requirements of drug substance and subsequent drug product means the life cycle management from clinical phases through to commercial launch poses significant challenges requiring specific expertise.
When outsourcing any aspect of the supply chain, success depends on both sponsors and vendors operating
as a true partnership with both sides understanding the requirements relating to all aspects of the
supply chain. Strong, collaborative relationships and clear communication are the hallmarks of robust
A panel of experts from PCI Pharma Services and three Life Sciences companies discussed challenges
and opportunities related to the development, clinical phases and commercialization of biologics.
They offered insights on how to improve sponsor-CDMO relationships.