How to achieve scalable freezing & thawing of biopharmaceuticals

micheal-eder

Michael Eder

August 9, 2021

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"Scalability" is and will remain an important topic in Biopharma. 
No matter what area of application, it will be necessary to scale-up or down at some point. Scaling-up from doing research in small lab environments with a handful of scientists to commercial production of bulk drug substances, vaccine production or cell and gene therapies entails a number of challenges.

What is scalability?

Scalability around freezing means the ability to guarantee constant stress on proteins (biopharmaceutical molecules) in all scales, filling volumes and loading scenarios.

How to enable scalability?

Single Use Support fulfils this requirement by standardizing the IFGS – ice front growth speed – for all possible scenarios regardless of the filling volume and type of bags but also regardless of the type of system, i.e. whether LabScale or LargeScale.

The "Scalability Guide" illustrates how to enable scalable results regardless of the

How to achieve scalable freezing & thawing of biopharmaceuticals

Scalability around freezing means the ability to guarantee constant stress on proteins (biopharmaceutical molecules) in all scales, filling volumes and loading scenarios.

Single Use Support fulfils this requirement by standardizing the IFGS – icefront growth speed – for all possible scenarios regardless of the filling volume and type of bags but also regardless of the type of system, i.e. whether LabScale, MidScale or LargeScale.

Scalable bulk drug substance process with single use technologies

Batch size volume and load independent controlled freezing and thawing results:

Controlled freezing and thawing with all bag sizes – from 3 liters to 300 liters. Example of freeze/thawing curves of a fully scalable process

3 liters / pre-clinical or Phase 1/2

small-scale-4-800ml

150 liters / Phase 2/3 or commercialized

pftu-16-8200ml1

300 liters / commercialized

lssp-6-50l
Scalability Guide RoSS.pFTU

Freeze & Thaw Scalability Guide

Scalability around freezing means the ability to guarantee constant stress on proteins (biopharmaceutical molecules) in all scales, filling volumes and loading scenarios.Single Use Support fulfils this requirement by standardizing the IFGS – icefront growth speed – for all possible scenarios regardless of the filling volume and type of bags but also regardless of the type of system, i.e. whether LabScale, MidScale or LargeScale
micheal-eder

Michael Eder

Senior Marketing Manager

Michael Eder, MA, is Senior Marketing Manager at Single Use Support. He is expert in pharma and health communication with his 8+ years experience in pharma. After completing his master's degree in International Healthcare Management at MCI The Entrepreneurial school in Innsbruck, he has gained experience in the pharmaceutical field. Michael creates articles about Freeze Thaw applications and Platform solutions from Single Use Support and is the author of current news with Single Use Support worldwide. 

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