Solving Cold Chain Issues for
Providing additional support and specialized cold chain expertise for global pharmaceutical companiesLET'S TALK
Cold Chain Challenges for Biopharmaceutical Manufacturers
As a large, global pharmaceutical company, you have deep domain expertise and extensive in-house capabilities across pharmaceutical drug discovery, development, and manufacturing. And you likely have a robust R&D pipeline with many drug candidates at various stages of development. As more of your drug candidates move beyond traditional pharmaceutical approaches—encompassing cell and gene therapies, monoclonal antibodies, and other biologics—even the most expansive in-house resources and expertise can be taxed.
A growing number of advanced biologic therapies have emerging cold chain regulatory requirements. But when it comes to designing and implementing a complex cold chain strategy, even the largest pharmaceutical manufacturers don’t always have the resources to devote to the task. With competitive pressures to get new therapies to market fast, prolonged timelines for traditional regulatory approval processes, and high failure rates in the clinic, you can’t afford costly delays due to cold chain regulatory obstacles.
How Modality Solutions Can Help
Some of the largest global pharmaceutical manufacturers rely on Modality Solutions to help address their cold chain challenges—trusting us to augment their in-house cold chain engineering, advise them on unique drug transport challenges, and offer our unrivaled regulatory expertise. We’re also the only provider with the specialized expertise to offer highly complex transport simulation for drugs with cold chain requirements.
Case StudiesView All Case Studies
TEVA CASE STUDY:
A Comprehensive Look at Cold Chain Challenges and Solutions in a Global, Multimodal Logistics Network
Transporting drugs in pre-filled syringes in low-pressure cell environments left Teva concerned about plunger movement and drug sterility risksView the case study now
SHIRE CASE STUDY:
Creating a Compliant, Scalable Temperature-Controlled Shipper Qualification Process for Shire
When Shire determined that its inter-site shipping process for frozen drug doses wasn’t adequate or scalable, it turned to Modality Solutions for help...View the case study now
Regeneron Case Study:
How Plunger Movement Studies Helped Regeneron Meet Tight BLA Filing Timelines
For drugs in pre-filled syringes, it’s critical to ensure plunger movement during transit doesn’t impact the product’s sterility. Modality Solutions provided that assurance for Regeneron…View the case study now
Our Solutions for
Modality Solutions supplements the in-house resources of leading pharmaceutical manufacturers, with capabilities that help move the most advanced therapies through rapid, successful approval.
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 More
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 More
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.Learn More
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 More
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.Learn More
Did You Know?
The average cost to develop a new drug that gains marketing approval is $2.6 billion (including out-of-pocket and time costs).
The overall likelihood of approval of a drug that begins Phase I is just 9.6% (based on 2006-2015 data).
Traditional vaccine approval timelines average 7-8 years through Phase III, vs. 18 months for Fast Track through Phase II.
What Our Clients Say
“Their integrated team approach brought immediate benefits to my team by augmenting our skills on several project teams simultaneously. They were valued members of the team the first day on the job!“.
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