Shorten Time To Market With New Data-Driven Lyophilization Process

By Jeff Tremain, Associate Director, Business Development, AbbVie Contract Manufacturing

Lyophilization has become a necessary and effective component of drug product manufacturing across the pharmaceutical industry, driven by safety, quality, and stability. Lyophilization remains a complex process that poses particular challenges during tech transfer and scale-up, but newer, data-driven approaches offer more efficient routes to process optimization. The use of computational fluid dynamics (CFD) for modeling development, advanced analytics, and state-of-the-art GMP lyophilization equipment enables better understanding of the process and reduces the time required for optimization of robust, scalable lyophilization processes. Selecting the right manufacturing partner with appropriate lyophilization expertise, experience, and leading-edge data and analytical capabilities can reduce the drug development process and expedite time to market for lyophilized drugs.