The Benefits Of End-To-End Formulation And Fill/Finish Of Biologics

By Tyler Jones, PhD, Director, Formulation, and Geno Worke, Head of Manufacturing, Curia

Due to their delicate nature and sensitivity to various processes, proper formulation development is crucial for biologics. Review the challenges of transitioning a promising drug candidate from initial formulation stages to full-scale manufacturing.

The success of manufacturing hinges on a strong link between formulation development and manufacturability where early formulation decisions can significantly impact future production. A well-defined biologic drug product requires a deep understanding of the molecule's properties and its critical quality attributes. Effective formulation development must consider potential impurities that can affect the final formulation.

Close collaboration between formulation development and clinical fill/finish teams fosters smooth technology transfers, minimizes problems, and leads to faster development with improved quality and safety.

Dive deeper into the importance of understanding and managing impurities in drug formulations. Explore a case study that demonstrates how metal contaminants introduced during manufacturing can accelerate oxidation and how this was successfully mitigated. Learn more about the tech transfer process in pharmaceutical manufacturing, focusing on factors such as solubility, material compatibility, and product concentration.