Formulation Development: The Key To Product Stability

Biopharmaceutical development hinges on a robust Chemistry, Manufacturing, and Controls (CMC) strategy. CMC underpins the provision of a well-defined product for preclinical and subsequent clinical trials. Initial CMC activities involve establishing a manufacturing process alongside analytical development to generate assays for monitoring and controlling both the process and the product itself. Formulation development, the process of identifying an optimal combination of the active biotherapeutic and excipients, is an integral yet frequently overlooked aspect. While a buffered saline solution might be considered sufficient for early development, a more strategic approach integrates formulation development alongside the initial process development activities. This ensures biotherapeutic stability, streamlines incorporation of the formulation into the manufacturing process, and minimizes the risk of later formulation changes. Such changes necessitate comparability studies to demonstrate continued safety and efficacy, potentially incurring cost increases and timeline delays due to the need for revalidating analytical methods.

Labcorp offers comprehensive biopharmaceutical Chemistry, Manufacturing, and Controls (CMC) analytical support throughout the development lifecycle. Our services encompass the entire spectrum, from initial R&D discovery studies to quality control (QC) batch release testing for clinical trials and beyond, extending to support commercialization. We leverage extensive experience and insights gained from working across diverse biotherapeutic modalities, including recombinant proteins, vaccines, and cell and gene therapies. This expertise allows us to collaboratively design the optimal suite of analytical studies tailored to your specific molecule. Additionally, we can provide valuable data review and analysis, assessing existing data to identify any need for further or repeated studies. This comprehensive approach ensures the generation of robust and reliable CMC analytical data, critical for the successful development and commercialization of your biopharmaceutical product.