The impact of the freeze/thaw process on workflows requires it be treated as a unit operation of its own.
Based on current trends, 30 of the top 50 global biopharma products will require cold chain handling resulting from more complex therapeutics, scale-up of biosimilars, expanding distribution range, regulatory increases, and pandemic-targeted therapies. Ensuring your freeze/thaw workflow is validated along the way is critical in the safe delivery and distribution of sensitive products, as well as time, expense, and patient considerations. Protect, fill, freeze, store, ship, thaw, and drain; there are many opportunities for failures to happen along the process workflow.
A cracked bag can cause contamination. Warm temperatures during shipping could compromise drug proteins. Getting it right during validation ensures that the product can be delivered to patients the way it was intended.
Ensuring the safety, purity, and efficacy of biopharma products continues to be at
the forefront of drug manufacturers’ development and delivery process. Complex therapeutics coupled with multifaceted global logistics require validation throughout the drug manufacturing journey. For long-term product stability and decoupled manufacturing flexibility, freeze/thaw workflows are employed. Here, not only is storage temperature important, but container integrity and rates of freezing and thawing can compromise drug proteins. Customers need a controlled, consistent, and scalable cold chain workflow where product materials are stored, handled, or transported in a manner that mitigates risk for breakage, contamination, and expensive product loss.
Four important considerations to validate in your freeze/thaw workflow. How do you validate these? What are the pitfalls?
1. Primary Container
- Understanding the impact from all fluid contact surfaces on the biological product. Characterizing the product’s sensitivities (pH, UV light, adsorption, etc.) and validating primary contact materials that ensure product purity and stability during storage and transport.
2. Freeze/Thaw Process
- Developing and validating a repeatable freeze and thaw process that enables maximum product recovery. Utilizing a cooling and warming rate that reduces cryoconcentration, aggregation, denaturation, or other undesirable changes to the product’s critical quality attributes.
3. Scalable Freeze/Thaw Equipment
- The freeze/thaw process should utilize scalable equipment that can be validated at the initial lab/feasibility scale all the way up to production/commercial scale. Identification and sourcing of new equipment
or utilization of existing infrastructure will guide the validation approach.
4. Shipping/Distribution Lane
- Shipping containers and related packaging materials must be validated in both thermal and mechanical transportation environments that best represent the expected distribution lane. This reduces the risk of container breakage or contamination as well as temperature excursions that compromise product integrity.
As a trusted partner provider of single-use solutions for bulk freeze/thaw storage
and transport, we understand unique customer needs. By delivering customized solutions backed by a global infrastructure, customers receive beneficial outcomes.
Our world-class Life Sciences Technology Center is dedicated to offering customers access to experts who, with their deep knowledge of testing, equipment, and containment, will guide you through freeze/thaw process optimization strategies.
Learn more about how we can help.