TempChain Applications
Cold Chain Packaging for Cell & Gene Therapy (ATMPs)
Supporting the advanced therapy community with temperature-controlled packaging guidance for cell therapies, gene therapies and ATMPs including GDP-aligned documentation, qualification reports and a consultation-first approach.
The Cold Chain Challenge for ATMPs
Advanced Therapy Medicinal Products including CAR-T cell therapies, gene therapies and stem cell products represent the frontier of pharmaceutical innovation and some of the most complex cold chain requirements in the industry. These living medicines often require Ultra-Low Temperature (ULT) storage and transport at -80°C or below, though some next-generation cell therapies are now designed for cold chain (+2°C to +8°C) distribution significantly simplifying the logistics chain.
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For clinical operations managers at specialist treatment centres, hospital pharmacies administering ATMPs and life sciences companies developing advanced therapies, the packaging component of the cold chain is critical. Packaging failures at ULT temperatures can be catastrophic for products costing hundreds of thousands of pounds per dose, there is no room for error.
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Puffin Packaging works with cell and gene therapy teams to identify suitable TempChain packaging options for each product, temperature range, transit duration and documentation requirement from refrigerated +2°C to +8°C) applications through to specialist low-temperature support where appropriate.
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Applications
CAR-T, gene therapy, stem cells
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Why ATMP & Life Sciences Teams Choose Puffin Packaging:
🗹 UK-Based Expertise
Close to the growing cluster of UK cell and gene therapy manufacturers and NHS specialist treatment centres. We distribute across the UK, Europe, North America, South America and Asia.
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🗹 Consultation-First Approach
ATMP cold chain requirements are highly product-specific; we work with your team to identify the right solution.
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🗹 Qualification Reports
To support your IMPD (Investigational Medicinal Product Dossier) or marketing authorisation submissions.
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🗹 ISO 9001 & 14001 Certified
Quality and environmental standards appropriate for life sciences preferred supplier qualification.
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🗹 Scalable Supply
From small Phase I trial quantities through to commercial-scale ATMP distribution.​
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Frequently Asked Questions
Do you provide ULT packaging for cell therapies requiring -80°C storage?
Some ATMP applications require specialist ultra-low temperature solutions, while others are designed for cold chain distribution. Contact our team with your product’s storage, handling and transit requirements and we will advise on the most appropriate route and available qualification information.
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Is your packaging suitable for CAR-T cell therapy distribution?
CAR-T cell therapy packaging requirements vary significantly between products some require ULT (-80°C), while next-generation CAR-T products are being developed for cold chain distribution. Contact our team with your specific CAR-T product's storage and transit requirements and we will advise on the most appropriate Lunda TempChain configuration and provide qualification reports to support your supply chain documentation.
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Can you support clinical trial supply as well as commercial ATMP distribution?
Yes. We supply packaging for both investigational ATMP clinical trials and commercial-scale ATMP distribution. Our qualification reports are suitable for inclusion in IMPD submissions and marketing authorisation dossiers. We can work with clinical supply managers, CROs and ATMP manufacturers at any stage of development.
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What documentation can you provide for ATMP regulatory submissions?
We provide qualification reports which can be used to support IMPD packaging sections, manufacturing site master files, and NHS specialised commissioning documentation for approved ATMPs.
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Do you work with NHS specialist treatment centres as well as ATMP manufacturers?
Yes. We are happy to supply both the ATMP manufacturer/sponsor and NHS specialist treatment centres, depending on which party in the supply chain is responsible for the packaging component. If you are an NHS pharmacist or clinical operations manager working with an approved ATMP.