Impact of Scalable Freeze/Thaw Cycling on Protein Stability and Structure
Freezing and thawing of biologics is often overlooked in the biomanufacturing workflow. Considering its impact on critical quality attributes in post downstream processing, it should be treated as a unit operation of its own. And like most unit operations, freeze/thaw has its own set of process challenges focused on product stability, integrity, and scalability.
For commercial scale freeze/thaw of bulk active pharmaceutical ingredients (API), a model protein study can help to better understand and alleviate risks.
This webinar will:
- Review key requirements and considerations for freezing bulk drug substances or APIs
- Evaluate a model protein stability study to determine optimal freeze/thaw solutions
- Highlight the challenges associated with freeze/thaw of bulk API, specifically proteins and monoclonal antibodies
- Share key characteristics of a scalable freeze/thaw commercial unit operation
- Demonstrate the importance of the right formulation, container, and freeze method on product quality attributes through a model protein study
About the Presenters:
Entegris, Cold Chain Applications Engineer
Mr. Siddiqui joined Entegris in 2019 as an applications engineer. He came to Entegris from Sartorius Stedim Biotech, with experience in single-use freeze/thaw and cold chain operations. He is currently focused on expanding opportunities for fluid management solutions, particularly in low temperature applications for existing biologics and emerging therapeutics. Mr. Siddiqui has earned a master’s degree in chemical engineering from the University of California, Berkeley with a focus in product development.
Entegris, Field Applications Technologist
Julien joined Entegris in 2021 as application technologist covering the EMEA region. Julien holds an engineer degree and a PhD in biotechnology (Paris-Diderot) and spent the last decade at the interface of nanotechnology, biotechnology, and molecular medicine. After various postdoctoral experiences in academia developing technologies to create and characterize molecules and bionanomaterials for various applications, Julien moved into industry in 2015. He has authored/coauthored ~35 publications and his current focus is to help drive long-term business, moving forward locally keeping close technical relationships with customers and partners in EMEA.