Manufacturing Considerations For An Early-Stage Advanced Therapy Company

By Jim Watson, Vice President, and Andrew Doppstadt, Manager, Project Farma

Maximizing an early-stage biopharma’s chances of success starts with the right manufacturing and outsourcing strategy. Many new companies may lack the capital and resources to perform every function in-house; road mapping a strategy that accounts for this, and subsequently identifying the manufacturing partners to fill gaps in expertise or capability, is critical to maximizing their resources and potential for success.

The approaches a new biopharma can take to structure their business are diverse – do they want to outsource entirely to a contract development and manufacturing organization (CDMO)? Do they want to retain ownership over the manufacturing process? Understanding the costs, benefits, challenges, and timelines that accompany various strategies requires a multifaceted evaluation of the current market, as well as a thorough understanding of the challenges that can arise from a specific therapeutic modality, a company’s existing resources, the strength of its team, and other variables.