Developing and validating a robust freeze/thaw process while meeting regulatory guidelines is a multifaceted challenge. The biopharma industry increasingly demands cold chain products and operations. That’s due to the scaling of complex therapeutics, a challenging global supply chain, and growing shipping complexities. Improper freeze/thaw processes can ruin sensitive therapeutics and cell and gene therapies, but the right tools can help you reduce cryo-concentration and bioburden while achieving the best return on investment and the greatest optimization of your process.

Minimizing Risk for Biologics

Even the slightest temperature changes cans compromise drug product. This includes incidents as seemingly minor as holding a freezer door open to find an inconveniently placed item. Companies can always prevent these incidents to save time and money. For example, biologics in different stages of the freeze/thaw process do not always belong in the same freezer, especially if they require different freeze/thaw and storage rates. Keep temperatures uniform and get the most out of your product by ensuring your freezer is appropriate for each application. Meanwhile, optimizing storage within your freezer is one of the best ways to make sure your temperatures are consistent.

Reducing Cryo-Concentration

Protecting your product during the freeze/thaw process can be delicate. Freeze too slowly, and your proteins may aggregate and degrade. Thaw in a water bath, and you might encounter contamination. Cryo-concentration, where protein is not evenly distributed throughout your frozen container, poses the most common risk to critical product quality attributes. Improper freeze/thaw processes can ruin sensitive therapeutics and cell and gene therapies, but the proper tools can help you reduce cryo-concentration and bioburden while achieving the best return on investment and optimize your process. Some tips and considerations include:

• Ultralow Freezer selection — uncontrolled freezing may result in uneven ice formation and cryo-concentration
• Thawing equipment —thawing rates are just as vital as freezing rates in their impact on products
• Storage container — is your biologic stored in a bottle or bag?

Technology Center

We partner with our customers to understand their needs for single-use solutions regarding bulk freeze/thaw and transport. Customers obtain valuable outcomes in delivering customized solutions backed by a global infrastructure.

Our Life Sciences Technology Center in Billerica, MA showcases FARRAR’s™ controlled rate freezer chamber. Using this and other technologies, life sciences customers can leverage our expertise in cold-chain challenges to reduce costs, decrease speed to market, and optimize processes.

Looking for help minimizing product loss or increasing supply chain security? We can do that and more – increasing purity, mitigating particulate contamination, improving product tracking, and even assisting with product validation. Our premier facility brings Entegris’ tools and technologies together in one place where customers can test equipment for freeze/thaw processes to determine which products best fit their needs.

We can help you make the right choices by helping set up studies like:

• Define and understand the distribution modes and freeze/thaw equipment
• Contain solution design including bag, shell, and shipper
• Custom bag chamber design validation
• Freeze study
• Freeze/thaw recipe design and verification
• V&Q>ASTM 4169, integrity verification
• E&L and compatibility assessment and/or services
• Product confirmation (particles, aggregates, titer, etc.)

Interested in booking an in-person or virtual tour of our Technology Center? Reach out for more information.

Partnership

FARRAR’s offerings and services, combined with Entegris’ life sciences solutions, offer customers end-to-end, innovative solutions in the advancement of temperature technology, quality, and manufacturing while improving efficiency, reliability, and affordability.

Helping customers create optimal freeze/thaw solutions, processes, and workflows to get maximum return on investment, increase efficiency, reduce operating costs, and meet sustainability goals is what we do best. Check us out to learn more; we’re happy to help!

Brigid Connor, Life Sciences Market Leader, Entegris | A content marketing manager by trade, Brigid’s expertise lies in life sciences storytelling, making technical concepts easy to digest, allowing customers to get the most from Entegris products and services.