Recombinant Proteins: Understanding 5 Key Process Development Challenges

By Tom Stapp and Kelsey Gomez, Chiron Recombinant Proteins

For many biotech companies, particularly those developing orphan or small-market drugs, process development is not the first thing on their mind. While they understand the importance of creating a scalable and repeatable process resistant to supply chain disruptions, the need to conceive a viable molecule takes precedence in early development.

Once a company has demonstrated proof of concept, it is important to ensure process elements like scalability, sourcing raw materials, and GMP adherence are considered during process development.

Every project is different, and some elements may not have even been considered, while others may have been partially implemented, but not optimized. The company must use this baseline in determining which process elements it can handle internally, and which elements might, or will, require outsourced assistance.

A CDMO partner generally aims to imbue a process with efficiency, cost-effectiveness, and scalability conducive to GMP production. To accomplish this, the CDMO seeks a holistic view of the existing process, upstream and downstream, to understand which necessary elements its client already has implemented and what is missing. Having a partner that understands your process, from start to finish, empowers an organization to be proactive in solving problems before they occur and flexible in adjusting its process and strategy as the market dictates.