Case Study

Accelerating The mAb Formulation Process

Monoclonal antibody MAB GettyImages-1294461540

A critical step in downstream processing, formulation is designed to maximize molecule stability. It is essential in monoclonal antibody (mAb) development, as it typically entails screening to identify the ideal combination of buffers, pH, and excipients. Often, buffers and pH are evaluated first and together to ensure pH can be maintained, as pH is one of the most important parameters impacting molecule stability. Subsequently, excipients are screened to select those most adept at stabilizing the molecule, preventing aggregation or degradation, providing freeze-thaw protection, and addressing other pertinent parameters. However, this requires multiple, sequential screening and analytical steps that can be time-consuming, labor-intensive, and costly. Additionally, the formulation timeline is prolonged as this standard process commonly begins with non-representative material. Learn about a one-step process that was developed to streamline formulation, effectively reducing timelines from approximately 14 weeks to 8 weeks for this critical step.

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