Deliver A Technical Package That Serves On-Time Injectable Project Completion

By William Powers, Singota Solutions

The accuracy, robustness, and completeness of the technical package an organization submits to its development and/or manufacturing partner is critical to meeting fill project timelines. A detailed conversation at project outset between the scientists who completed formulation work and the CDMO avoids many such issues, or at least prepares both parties for potential problems.

First-time development projects are among the most susceptible to these issues. Smaller or emerging organizations may be less prepared due to smaller staffs and fewer resources, while larger companies have the benefit of more SMEs and more available resources. The heavy lifting of early drug development work is increasingly handled by small companies, which lack the benefit of a huge stable of scientists, have stakeholders to appease, and — almost always — work under the cloud of an ambitious timeline. This can lead to a technical package that is not as complete and accurate as both partners would prefer. Issues exposed during fill/finish typically are related to three areas: analytical test methods, formulation, and drug substance.