Protecting your product throughout the freeze/thaw process can be a delicate task. Freeze too slowly, your proteins may aggregate and degrade. Thaw in a water bath, you might encounter contamination. Most commonly, cryo-concentration, where your protein is not evenly distributed throughout your frozen container, poses a risk to critical product quality attributes. There are countless ways 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 optimization of your process.
Starting with method development, the cold chain process is the heart of how to maximize yield. Now that you have your big vat of biologics, the following factors play a vital role in making the most of your efforts:
- How you fill into bags
- What you freeze your product in
- How you ship your product
- How and what your product is thawed in
- How you perform final dispense
No matter your therapeutic, your freezer plays a vital role in the cause and/or effect of cryo-concentration. Here are some considerations to ponder and tips to prevent cryo-concentration:
- Storage container – is your biologic stored in a bottle or bag? Our single-use Aramus™ bags are high purity, non-leachable, robust, and tailored for your freeze/thaw workflow. The unique 2D geometry of Aramus bags maximize thermal transfer when paired with the right shell in the right freezer. Bottle geometries do not support scalable heat transfer and can only be used in blast freezers, resulting in inconsistent freezing across sizes. Don’t limit yourself with bottles and risk product viability from limited freezing techniques.
- Freezer selection- uncontrolled freezing may result in uneven ice formation and cryo-concentration. Controlled rate plate and forced-air freezers minimize this risk and allow you to customize the application-specific freeze rate for your biologic. Is your freezer up to the task?
- Thawing equipment- Do you thaw at room temperature or in a water bath? How long does it take you to thaw? Thawing rates are just as important as freezing rates in their impact on product quality. Diminish the threat of contamination and improve product viability using controlled thaw systems that uniformly thaw your biologic.
Our Life Sciences Technology Center has the tools and equipment to show you firsthand how to optimize your freeze/thaw workflow, with technology for every step from fill to dispense. We’re your partner in delivering beneficial customer outcomes by configuring optimized freeze/thaw workflow solutions. Let us help you optimize your process today.
