Lyophilization and Freeze Drying

Lyophilization and Freeze Drying

Solutions for Lyophilization Process
and Formulation Development

What is lyophilization?

Lyophilization, or freeze-drying, is a technique used to render biologics and large molecule drugs stable for transport and long-term storage. The pharmaceutical lyophilization process is quite complex, with a series of precisely controlled temperature and pressure steps.

Process parameters and physio-chemical properties, such as freeze-dried cake moisture content, reconstitution time, integrity, homogeneity, uniformity and potency, are often employed to confirm drug product quality as well as its stability under storage. Despite decades of collective experience, the lyophilization process remains to be time-consuming and costly in both development and manufacturing scale-up phases due to the challenges in cycle development, process optimization, and cake characterization.

DigiM microstructure characterization of a lyophilized protein drug product for formulation and process development (freeze drying xrm case study)

Non-destructive visualization of a lyophilized protein cake
microstructure with XRM imaging.

Current analytical approaches lack the sensitivity and resolution to analyze these microstructure associated properties without affecting the inherent cake structure. At DigiM, we apply non-invasive X-ray microscopy (XRM), AI analytics of critical quality parameters, and image-based simulation to evaluate cake quality and mass transport properties of lyophilized materials. 

Application areas range from formulation and product quality assurance, lyophilization process development and inspection, and evaluation of new equipment and techniques such as spray-freeze drying. 

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Relevant Publications

IFPAC 2021 Presentation: Non-invasive 3D X-Ray microscopy imaging technique for quantitative characterization of lyophilized drug product
In collaboration with FDA

Access the talk slides here, or login to watch the talk

Drug Development and Delivery Paper: Non-Invasive, Quantitative Characterization of Lyophilized Drug Product Using 3D XRM Analytics
In collaboration with BMS and Moderna
Read the open access paper here

Want to learn more? Browse our other publications here.

Contact us for more information

S. Zhang, J. Lomeo, A. Zhu. Non-invasive 3D X-Ray microscopy imaging technique for quantitative characterization of lyophilized drug product, Talk presented at International Forum on Process Analytical Chemistry (IFPAC) Annual Meeting, 2021 Feb 28-Mar 5; Virtual. With the FDA.

S. Zhang, J. Goldman, X. Chen, J. Rowe, S., Lin, L. Zhou, Non-Invasive, Quantitative Characterization of Lyophilized Drug Product Using Three-Dimensional X-Ray Microscopy Analytics, Drug Development & Delivery (January/February) (2020) 32-40. 

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