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Solving Cold Chain Issues for
Drug‑Device Combination Products
Helping MedTech innovators ensure their combination products are up to the challenges in the cold chain.
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Cold Chain Challenges for Drug-Device
Combination Products
Medical device, diagnostic, and digital health innovators are reshaping healthcare. Technologies like AI, robotics, patient-monitoring wearables, drug-eluting stents, and many others are helping people live longer and healthier. But transporting these breakthrough medical technologies is a challenging proposition with complex regulatory requirements.
When your MedTech is a combination drug/biologic-device therapy, bridging existing data to a new NDA or BLA filing means demonstrating your therapy will meet rigorous cold chain requirements. Whether you’re a biopharma looking to add your therapy to a device (like an autoinjector for drug delivery) or a device manufacturer looking to include a therapy on your device (like a drug-eluting stent), you must demonstrate that the device functionality and drug efficacy, purity, and potency aren’t impacted in the transportation process.
How Modality Solutions Can Help
Modality Solutions’ transport validation studies and regulatory expertise help you meet rigorous FDA requirements for combination products and other innovative biomed devices. Our subject matter experts deliver everything you need to clear the hurdles and achieve a successful filing for your combination product or stand-alone medical technology.
- Regulatory expertise with BLAs and NDAs. Combination products present issues that cross the regulatory and scientific boundaries of both centers. Modality Solutions works extensively with both, understands how they operate, and knows what they require.
- Bridging strategies supported with transport simulation. When combining a device and a therapy, you need a scientifically sound and robust bridging strategy. Modality Solutions provides it — taking a risk-based approach that regulators will accept. We identify transportation risks and test them along the edges of the operating space in our one-of-a-kind transport simulation lab.
- Engineering-based comparative analysis. We review existing studies and assessments, then identify whether the risk profile of the drug or biologic constituents could affect the risk profile of the combination product. This comparative analysis pinpoints any differences between the original drug and device and the proposed combination product that could impact the cold chain.
Case Studies
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ABBOTT VASCULAR CASE STUDY:
Addressing Temperature Excursions and Reducing Total Delivered Cost for an Innovative Combination Therapeutic
See how Modality Solutions identified temperature excursion reduction opportunities and minimized non-conformance rates for Abbott's Absorb stents.
View the case study nowWhy MedTech Innovators Partner with Us
Learn More About us- We provide specialized technical capabilities in medical device functionality and plunger movement / pre-filled syringes
- We’ve helped obtain approval for or improved upon the cold chain post-approval for 20+ combination therapies.
- We’ve worked with combination therapies of all types—including drug-eluting vascular scaffolds, pre-filled syringe medical and dental products, devices for repairing abdominalaortic aneurysms, granulocyte colony-stimulating factor (G-CSF) products, and many more.
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Our Solutions for Drug‑Device
Combination Products
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.
Learn MoreTransport 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™.
Learn MoreCold Chain Consulting
Cold Chain 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 Cold Chain Consulting and Cold Chain Engineering™ services are invaluable. Our cold chain consultants and experts draw on their extensive experience to help you overcome complex supply chain challenges, reduce risk, and meet regulatory requirements at every phase.
Learn MoreASTM/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.
Learn MoreCold 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.
Learn MoreDid You Know?
8.2%
The global market for drug-device combination products is forecast to grow at a compound annual growth rate of 8.2% through 2027.
77 M
The expanding geriatric population is expected to hit 77 million by 2034 in the US alone, spurring high demand for drug-device combination products.
Pervasive, chronic conditions like diabetes and cardiovascular disease will continue to drive demand for medical technology and BioMed devices.
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
Learn MoreWhat Our Clients Say
“Modality Solutions provided the expertise required to integrate our cold chain management systems.”
“Their insight into the cold chain regulations was invaluable.”
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for your drug-device combination product?
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