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.
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.
End-to-end solutions for cold chain processes
Controlled and scalable freezing of biologics
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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.
Single Use Support’s solutions ensure the integrity of drug substances throughout the entire cold chain – delivering GMP readiness and reducing product loss.
Vendor-agnostic
Our solutions are designed to work seamlessly with bags and bottles from all leading providers – giving you flexibility without compromise.
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.