Solving Cold Chain Issues <br>for Emerging Biopharma

Solving Cold Chain Issues
for Emerging Biopharma

Helping emerging biopharmaceutical companies navigate global regulatory guidelines and tackle cold chain challenges.

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Cold Chain Challenges for Emerging Biopharma

Whether you develop CAR-T cell therapies, biologics, or other advanced therapies, you’re focused on innovating to bring new clinical trial candidates to market and address unmet medical needs. Companies like yours represent a growing share of the innovation landscape. And with one or more clinical trial candidates in the pipeline, you need to optimize your return on investment. As you build out your in-house staffing, facilities, andcapabilities, a strong network of experienced consultants and contractors can help you reach your goals and put your funding to best use.

Global regulatory guidelines for pharmaceutical cold chain therapies are confusing, complex, and difficult to navigate. Even the most innovative emerging biopharmas typically don’t have the in-house engineering resources, regulatory expertise, or pharmaceutical cold chain filing know-how to tackle these challenges alone. And without easy access to our unique transport simulation technology or deep domain expertise available 24/7, it can be tough to meet complicated requirements and get to market fast.

How Modality Solutions Can Help

Modality Solutions combines all the expertise and experience emerging biopharmas need to achieve your goal and ours: the successful, rapid approval of your therapy. Our end-to-end solution spots issues early in your clinical development cycle—avoiding approval delays, reducing costs, and ensuring successful validation for a timely filing.

We’ve navigated the complexities of NDA and BLA filing for many emerging biopharmas,applying our unrivaled regulatory expertise and biopharma supply chain experience to guide you to filing success.

Case Studies

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Morphosys Case Study:

How Robust Validation Planning and Transport Simulation Aided Accelerated Approval for MONJUVI™

When MorphoSys obtained Fast Track designation for MONJUVI, a monoclonal antibody treatment for lymphoma, establishing a robust pharmaceutical supply chain was key to gaining commercial..

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Atara Biotherapeutics Case Study:

Using Robust Cold Chain Validation to Support CAR-T Therapy Filing

Concerned about vial breakage when transporting its CAR-T therapy on pallets, Atara Biotherapeutics sought to improve the frozen logistics process and support the move to a refrigerated formulation in Phase II...

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Immunomedics Case Study:

How Transport Simulation Helped This ADC Therapy Achieve Fast Track Approval

TRODELVY™ represented a promising antibody-drug conjugate therapy for triple negative breast cancer, but filing obstacles threatened its commercialization. Immunomedics tapped Modality Solutions to...

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Why Emerging Biopharmas Partner with Us

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  • Complete, single-source pharmaceutical cold chain engineering, simulation, and testing capabilities
  • Expertise in the complexities of regulatory cold chain requirements and expectations
  • Guidance through the entire biopharma cold chain validation process—from proof of biological activity in phase II, to ramp up, through filing, submission, and post-approval commitments
  • Support for FDA feedback requests and other urgent situations

Our Solutions
for Emerging Biopharma

Modality Solutions provides the solutions proven to help biopharmaceutical innovators address cold chain challenges and obtain fast therapy approval.

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?

Emerging Biopharmas drove:

29

Original patents for 29 of the current top 100 drugs, accounting for 40% of US pharmaceutical sales in 2018

65 %

65% of all clinical trials conducted in 2018

58 %

58% of completed clinical trials (among those with a pharma sponsor)

90 %

90+% of next generation biotherapies, including cell and gene therapies and RNAi technologies

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

“We are very delighted to inform you the FDA has approved tafasitamab. On behalf of the whole team, we want to thank you for your great support. Well done! “

Kai Rosport, MorphoSys

Kai Rosport, MorphoSys

Ready to discuss cold chain needs
for your new biopharmaceutical?

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Ready to discuss cold chain needs <br>for your new biopharmaceutical?