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.
    A top-view image of a frozen single-use bioprocess container protected by a RoSS Shell.

    Why choose Single Use Support?

    • Minimized product loss: integrity of drug substances throughout the entire cold chain
    • Vendor-agnostic: independent from type and brand of single-use bags and bottles
    • Scalable: scale-up and -out while maintaining maximum product quality

    Our customers trust in us:

    Rentschler Biopharma
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    Reference Logo

    End-to-end solutions for cold chain processes

    From bench to bulk: Freezing biologics right

    Preview of Single Use Support's study about scalable freezing

    Download whitepaper

    Study: Scalable freezing of protein-based biologics

    In collaboration with Single Use Support, the Zürich University of Applied Sciences conducted a series of studies to explore how different freezing technologies and controlled freezing and thawing rates affect product quality. Results show experimental insights into cryoconcentration, protein stability, and the impact of freezing rates - highlighting how Single Use Support’s plate-based freeze-thaw platform ensures product integrity and process scalability.

    Study: Scalable freezing of protein-based biologics
     

    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
     

    More information

    Cold chain compliance for drug substances: Regulatory standards you should know about

    Cold chain compliance for drug substances: Regulatory standards you should know about

    Coming from manual and uncontrolled freezing methods, manufacturers risk non-compliance and poor consistency when cryopreserving drug substances. Non-compliant CDMOs also risk falling out of consideration for pharmaceutical companies seeking partn...

    Elisabeth Haas-Karagiannidis
    Elisabeth Haas-Karagiannidis
    Sustainable freezing in biopharma: Emerging trends & the role of natural gas

    Sustainable freezing in biopharma: Emerging trends & the role of natural gas

    There will continue to be an ongoing need for cryopreservation and cold chain management of drug substances. However, these processes will no longer depend on F-Gases.  The utilization of F-gases, also known as fluorinated greenhouse gases, is ste...

    Alexander Fuchs
    Alexander Fuchs
    Freezing drug substance – taking control over large volume pharmaceutical freezing

    Freezing drug substance – taking control over large volume pharmaceutical freezing

    In the manufacturing process of drug substances and during their long term storage, freezing is a necessary step to preserve product quality. However, various process parameters in freezing and thawing methods considerably influence the critica...

    Claus Exenberger
    Claus Exenberger

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