Impact of Scalable Freeze/Thaw Cycling on Protein Stability & Structure

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**Wednesday, October 27, 2021 at 11am EDT | 8am PDT | 4pm BST | 5pm CEST** Freezing and thawing at scale of API and BDS biologics is not routine and should be handled with the consideration given to any critical unit operation. This webinar highlights key protein related quality challenges associated with freeze methods. Optimization thorough model freeze/thaw studies are presented.

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Event Overview:

The freezing and thawing of biologics for storage and transport 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 API, a model protein study can help to better understand how formulations, primary containers, and freezing methods alleviate these risks. This webinar will:

  • Review key requirements and considerations for the freezing of bulk drug substances or APIs
  • Examine the properties required of a 50mL to 50L scalable system
  • Evaluate a model protein stability study to determine optimal freeze/thaw solutions

Key Learning Objectives:

  • Understand the challenges associated with freeze/thaw of bulk API, specifically proteins and monoclonal antibodies
  • Characteristics of a scalable freeze/thaw commercial unit operation
  • Importance of the right formulation, container, and freeze method on product quality attributes through a model protein study

Who Should Attend:

  • MS&T Engineers/Scientists (Manufacturing Science & Technology)
  • Process Development Engineer/Scientists
  • Associate/Senior Director of Process Sciences and Manufacturing
  • Protein Formulation Scientists/R&D Managers


Muhammad Siddiqui
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 will use his current role to expand 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.

Julien Muzard
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 & molecular medicine. After various postdoctoral experiences in academia developing technologies to create and characterize molecules & bionanomaterials for various applications, Julien’s moved into industry in 2015. He's author/co-author on ~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.



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