Avoiding delays during process development is central to successfully completing biopharmaceutical development on time and within budget. However, due to the complexity of the processes involved, many biopharmaceutical developers choose to work with an external process development collaborator. External process development collaborations can allow developers to benefit from next-generation technical capabilities without needing to make significant time and financial investments in new equipment and training. Developers can also utilize knowledge from specialists who have experience at each specific development stage and, as a result, understand how to overcome potential sources of inefficiency. This can also extend to avoiding inefficiencies that may arise in the future during commercial manufacturing, such as media formulation issues that only become apparent when the media is scaled up. As a result, leveraging a combination of experience and capabilities offers the possibility of accelerating the overall speed to market and reducing long term risks.
To achieve this success, it is crucial to choose a suitable collaborator. Although there are many different considerations that should be made, they can all be grouped into two categories — experience and capabilities. By considering both, a collaborative relationship can be assessed in a variety of pivotal areas. This can help maximize the likelihood of a successful agreement and help meet the overall project goals of streamlined and cost-effective process development. Ultimately, this may result in an accelerated speed to market and reduced long-term manufacturing risks, making the life-changing biopharmaceutical accessible to patients around the world.
This article will summarize several key attributes and capabilities to look for during the selection process.