Future-proof your biologics cold chain

Crying over product loss after freezing?

Protein instability after freezing can ruin an entire batch of biologics. Controlled freezing of drug substances in single-use bags and bottles helps manufacturers maintain product quality and increase productivity.

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Minimize product loss
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Control freezing & thawing
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Scale production capacity

Challenges in biopharma cold chain management

  • Product quality: Uncontrolled freezing can compromise critical quality attributes of drug substances, leading to instability, cryoconcentration, and loss of product integrity.

  • Compliance: Without validated & documented freeze–thaw processes, GMP‑aligned contamination control and data integrity requirements are at risk of non‑compliance.

  • Scalability: Biologics manufacturers face complexities when scaling from clinical phases to commercial production without compromising product quality.
    • Infographic of cold chain management methods solutions including primary & secondary packaging, freeze & thaw, ultra cold storage, and cold chain shipping.

    Controlled and scalable freezing of biologics

    Operator handling biologics with gloves on a cold chain integrity system, featuring text about biologics protection.

    Download App Note

    App Note: Cold Chain Integrity for Biologics

    What impact does controlled end-to-end cold chain management have on preserving the quality, potency and safety of biologics? Find out how Single Use Support's modular, automated technologies for single-use bags and bottles minimize cryoconcentration, prevent container damage and ensure consistent, sustainable handling that aligns with Annex 1 throughout bioprocessing.

    App Note: Cold Chain Integrity for Biologics
     
    • A top-view image of a frozen single-use bioprocess container protected by a RoSS Shell.

      Minimized product loss

      Single Use Support’s solutions ensure the integrity of drug substances throughout the entire cold chain – delivering GMP readiness and reducing product loss.

    • Mid-frame image of two pharmaceutical blast freezers by Single Use Support.

      Vendor-agnostic

      Our solutions are designed to work seamlessly with bags and bottles from all leading providers – giving you flexibility without compromise.

    • Mid-frame image of an operator using RoSS.pFTU Lab-Scale freezer for controlled freezing of cells or monoclonal antibodies (mAbs).

      Scalable

      Scale up and out while maintaining maximum product quality. A range of solutions for bags and bottles supports manufacturers from lab to blockbuster production.

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