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Discussion of Freeze/Thaw Workflows

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Discussion of Freeze/Thaw Workflows

Meet Regulatory Requirements to Ensure Patient Safety

Developing and validating a robust freeze/thaw process while meeting regulatory guidelines is a multifaceted challenge. The demand for cold chain processes and operations for biopharma products is increasing due to scaling of complex therapeutics, a challenging global supply chain, and growing shipping complexities. Ensuring compliance throughout the product journey is integral to mitigating risk for product loss and contamination.

inline-flow-chart-12368-1200x233The cold chain process can be explained in terms of:

  • Fill: Automating or manually delivering your solution
  • Freeze: Cooling down your solution by blast or plate freezer, this is also critical for thawing since biologics are temperature sensitive.
  • Store: Both bags and bottles are typical solutions for storing high-value products.
  • Transfer and Ship: Product withstanding temperature, vibration, and movement during travel is critical in terms of preserving product aseptic boundaries and eliminating the possibility of product loss. 
  • Thaw: In many cases, the same freezers that are used to freeze are also used to thaw. The biggest change during this step is proving drug reliability since biologics are temperature sensitive.
  • Transfer: Manual movement of product is a potential point of failure. Using a facility trolly is a next logical step but it is important to understand how this fits within your process regarding safety, staffing, and stability.
  • Dispense: Contamination is the major concern, but with the right connectors and single-use solutions, contamination can be prevented. In addition, Aramus™ single-use solutions have the maximum extraction rate of any single-use system (SUS) at 99%.

Safety, purity, and efficacy are critical product quality attributes that are protected with a validated freeze/thaw workflow. Customers need controlled, consistent, and scalable solutions to sustain those critical attributes. The greatest risks during sensitive freeze/thaw process are:

  • Protein degradation
  • Protein aggregation
  • Cryoconcentration
  • Ice nucleation
  • Container integrity
  • Product contamination

From bottles to stainless steel containers to bags, there are many single-use assemblies that can help protect your product during a freeze/thaw process. Considerations when determining what containment to use in your process:

  • Robustness
  • Multi-use
  • Weight and bulk for shipping
  • Cleaning and validation requirements
  • Low freezer utilization/optimization
  • Leaky seams and tubing
  • Gamma sterilizable

We understand the complexities of single-use solutions for bulk freeze/thaw and transport, and partner with our customers to understand their unique needs. In delivering customized solutions backed by a global infrastructure, customers obtain valuable 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.

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