Solving Cold Chain Complexities <br>for Cell & Gene Therapies

Solving Cold Chain Complexities
for Cell & Gene Therapies

Guiding the most innovative cell and gene therapies through the complexities of cold chain approval

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Cold Chain Challenges for Cell & Gene Therapies

Cell and gene therapies like CAR-T are transforming healthcare‑providing innovative treatment modalities that hold great promise for previously untreatable diseases, including orphan diseases and genetic conditions. By leveraging the patient’s own biological materials, these individualized therapies can prove life-altering.

Cell and gene therapies involve the most complex supply chain to validate in the biopharma industry, especially for a fully closed-loop autologous CAR-T cell supply chain that starts and ends with the patient. From tight timelines, to rigorous temperature requirements (whether cryogenic, deep frozen, or refrigerated), to the use of fragile vials for storage and innovative reusable packaging, the supply chain for personalized medicines is highly complex.

How Modality Solutions Can Help

Modality Solutions is uniquely qualified to optimize the cold chain and facilitate regulatory review and approval for cell and gene therapies like CAR-T and other individualized regenerative medicines. We leverage our deep knowledge of these complex therapeutics, unrivaled cold chain expertise, and a proven track record of helping biopharmaceutical companies overcome a complicated regulatory landscape to bring cell and gene therapies to market successfully.

From regulatory filing support, to customized engineering consulting, cold chain optimization, and rigorous transport simulation testing, Modality Solutions provides the full range of capabilities to guide your cell and gene therapy candidate through review and commercial approval.

Case Studies

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Atara Biotherapeutics Case Study:

Bringing an Innovative CAR-T Cell Therapy to the US and EU Markets

To gain approval for its new CAR-T Cell Therapy, Atara Biotherapeutics needed to demonstrate an ability to safely transport a fragile therapeutic with deep-frozen temperature requirements...

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Why CAR‑T Cell Therapy and Regenerative Medicine Innovators Partner With Us

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  • We’ve worked with over 50% of all CAR-T cell therapies submitted for FDA review.
  • Our team has designed and qualified dozens of thermal packaging solutions, including cryogenic temperature packaging for CAR-T cell therapies.
  • Our cell and gene expertise includes experience working with blood-based therapeutics.
  • No one has a better understanding of the regulatory nuances that impact the filing of a cell and gene therapy, orphan drug, or other regenerative medicine — or a better track record of successful outcomes.
  • Our knowledge of the ever-changing regulatory environment for advanced therapies and orphan drugs is unparalleled—and it grows with every new submission and review.

Our Solutions
for Cell & Gene Therapies

Regulatory Filing

Regulatory Filing

We help prepare you for a successful regulatory filing every step of the way—assessing your cold chain, drug stability, packaging, and third-party logistics qualifications; developing a validation master plan; conducting transport simulation testing; and preparing your team for the CTD submission and pre-approval inspection.

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Transport Simulation

Transport Simulation

Whether you need turnkey support or you want to augment your in-house resources, our customizable Transport Simulation Solutions can deliver the robust data regulators expect during your drug’s review and approval. We assess transport risks, develop validation master plans, and rigorously test drug formulations and packaging for the five hazards that can occur in transport—concurrently and at the edges of the supply chain’s operating space—through our ISO-certified Advantage Transport Simulation Laboratory™.

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Engineering Consulting

Engineering Consulting

When you’re preparing for a new filing, responding to an Information Request, or looking to improve the supply chain for a commercial product, our Engineering Consulting Solutions are invaluable. Our cold chain subject matter experts draw on their extensive experience to help you overcome complex supply chain challenges, reduce risk, and meet regulatory requirements at every phase.

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ASTM/ISTA Testing

ASTM/ISTA Testing

Modality Solutions can conduct rigorous, comprehensive testing of your therapeutic against a wide range of ASTM and ISTA standards at our independent Advantage Transport Simulation Laboratory™ or a third-party lab—ranging from plunger movement studies to confirm sterility and efficacy, to drug-device functionality testing, and many other applications.

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Cold Chain Optimization

Cold Chain Optimization

We help enhance your cold chain’s performance for therapeutics that have already reached the commercial market—reducing shipping and packaging costs while ensuring your drug product remains protected in transit. From package design engineering and evaluation, to packaging selection support, to logistics network design, our Cold Chain Optimization Solutions ensure your supply chain is up to the challenge of transporting fragile or controlled-temperature therapies.

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Did You Know?

Cell & Gene Therapy will grow to:

$35.4 B

The cell and gene therapy market is forecasted to grow to $35.4 billion by 2026, representing a compound annual growth rate of 22 percent.

Unique Capabilities We Can Put to Work For You

Cold Chain Engineering

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Transport Simulation Lab

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AI-Driven Cold Chain Optimization

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Emergency Response to Regulatory Inquiries

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What Our Clients Say

"Great job, it was a pleasure working with you! I think I may be speaking for all of us: we got more out of this project than we hoped. It really solidifies our delivery strategy"

Cornelius 'Niels' Rijneveld, CSL Plasma

Cornelius 'Niels' Rijneveld, CSL Plasma

Ready to discuss your
Cell & Gene Therapy’s cold chain needs?

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Ready to discuss your<br>Cell & Gene Therapy’s cold chain needs?