Modality Solutions’ Full Cold Chain Transport Validation Package Leads to Successful Filingread Details
Cold Chain Engineering
Find out how our Transport Simulation Lab can improve your drug stability testing.Request a Consultation
The Transport Simulation Lab concurrently tests for all five transportation hazards your drug may encounter in transit: temperature, pressure, humidity, shock, and vibration. Unlike sequential testing like the ASTM D4169 standard requires, or the snapshot-in-time that real-world shipping tests provide, our approach simulates the operating edges of your supply chain — yielding data that better reflects what may actually happen during transportation. Our engineers then translate that data into clear, usable information designed to give you and your regulators confidence in your drug formulation’s stability during transportation.
For protein-based drugs and other fragile therapeutics—like biologics, vaccines, monoclonal antibodies, antibody-drug conjugates (ADCs), cell and gene therapies, and any drug in pre-filledsyringes—the Transport Simulation Lab enables you to address regulators’ concerns about the stability of these therapy types in transit. And for Fast Track or other accelerated approvals, testing in our Transport Simulation Lab is typically the quickest way to obtain the robust data you need to address regulatory requirements and get your therapeutic across the finish line.
Our Transport Simulation Lab is critical to obtaining robust, relevant data on your drug formulation’s stability in transit. But that’s just the start. Our wide range of technical capabilities and engineering solutions complement our lab testing, providing the comprehensive support you need to ensure your cold chain is optimized and your drug product is protected during transportation.
See which solutions are right for your therapeutic type and your current clinical phase.
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.
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™.
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.
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.
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.
Cold Chain Engineering
Cold Chain Optimization
Join Modality Solutions Andrew Larrigan, Technical Operations Manager, and Carson Dickey, Senior Consulting Engineer,...read Details