Biopharma Process Development: Understanding Its Importance And Proper Execution

By Nerijus Makauskas and André Markmann, Northway Biotech

Implementing high-quality process development that considers GMP manufacturing from the start is critical to reducing costs and timeline disruptions associated with raw material supply chain insecurity, adhering to regulatory compliance, and avoiding process re-design at a later stage.

The consequences of inadequate process development are severe. If significant process redesign is needed, toxicology and Phase I/Phase II studies may have to be repeated. That loss of time and money is compounded by further reducing time for commercialization until patent expiration — if such detours need to be made. This volatile situation is likely to make finding a licensing partner for commercialization difficult, even if the product’s scientific mode of action is persuasive.

It is vital to secure a CDMO partner as early in a project as possible to allow time for thorough, well-considered process development.

In this article, explore the importance of fully fledged process development and how to pick the right CDMO partner and engage them as soon as possible.