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 sponsor-CDMO relationships.
Specifically, biologics manufacturing is experiencing short- and long-term capacity challenges as companies focus attention and resources on COVID-19 treatments and vaccines. Common hurdles in partnerships relate to product packaging, supply chains, clinical trials and regulatory policies. When selecting a partner to handle packaging operations, communication and the partnership between sponsor company and CDMO is as important as capabilities.
In this piece, 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.