Sharing process details externally might seem too close for comfort. But when it comes to process development (PD) outsourcing, a close collaboration can actually bring added benefits. Learn why from Gene and Eva’s latest trials.
Poor old Gene. It’s not nice to feel that your weaknesses are exposed. But as Eva knows, it is the other way around; a close collaboration can have its perks.
Take PD outsourcing for example. Imagine working alongside your service provider—both in person, in plant, and with complete transparency. Suddenly you can manage and control your process outcome effectively as your project is transferred across multiple sites.
This transfer could be to an external contract development and manufacturing organization (CDMO). Or maybe to another country in an emerging region. In both these cases it is crucial that the process outcome is comparable.
Close collaboration is king
Being the first to file a molecule and move to clinical trials puts you ahead of competition. So, process security and protection of IP is paramount when outsourcing to a CDMO. Especially when you are transferring to emerging markets.
A lot of patents for significant biologics are expiring in the coming years. And biosimilars are disrupting the biomanufacturing landscape with a 31.5% compound annual growth rate (CAGR) from 2015 to 2025 (1). To get to that market first, create a strong relationship with a good CDMO partner that you trust.
Curious to know how other biomanufacturers have used collaborations to solve common industry challenges to speed up their time to market? Download an e-book with process development case studies from Pfizer, Roivant, and mAbxience.
References
1. Data from EvaluatePharma database (2017)