Engineering Consulting Solutions

No matter how complex your cold chain challenge, Modality Solutions can craft a customized engineering solution that meets it head-on, bringing your therapy through a successful filing.

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Our Engineering Consulting Solutions Solve Tough Cold Chain Issues

We apply our in-depth Cold Chain EngineeringTM expertise to solve the most difficult cold chain problems, focusing on the three areas that are vital to an effective supply chain: strategy, planning, and execution.

Modality Solutions has provided cold chain consulting for more approved therapies, qualified more thermal packaging solutions and participated in more regulatory interactions than any other engineering firm in the industry.

When you partner with us, you gain the benefit of the most experienced cold chain experts in the industry—one with a proven track record of guiding the most innovative drug therapies to regulatory approval, efficiently and effectively.

Learn more about our specialized Cold Chain Engineering capabilities

Engineering Consulting Solutions for Every Need or Filing Phase

No matter where you are in the regulatory approval process, our Engineering Consulting Solutions will help you navigate your cold chain complexities and cross the finish line, quickly and effectively.

Leading pharmaceutical manufacturers, emerging biotech companies, and outsourcing partners rely on our cold chain expertise throughout their therapeutic’s journey—from NDA or BLA filing preparation, through the filing process, and after the product has reached the commercial market.

Are you unsure what cold chain risks your therapy will face?

We have the technical expertise to conduct a comprehensive risk assessment that ensures any safety, regulatory, or financial risks are identified and mitigated.

Do you need a fresh, third-party perspective on your cold chain?

Our cold chain experts can assess your current strategy, recommend the optimal design, and document our recommendation in a validation master plan.

Do you need to conduct transport simulation testing on your therapeutic?

We can conduct rigorous, comprehensive transport simulation testing of your drug product formulation against multiple hazards concurrently to confirm drug physical and chemical stability in transit.

Are you uncertain whether your shippers are equipped for the commercial supply chain?

Our thermal packaging experts can conduct a technical evaluation of the packaging used in your clinical trials and confirm if it’s scalable and cost-effective enough for the challenges of the commercial supply chain.

Do you need support for your regulatory filing?

Even if your network worked sufficiently during clinical trials, we can use the most current, proven validation techniques to prepare your therapy for commercial approval.

Are you in Phase I/II with your therapeutic?

Whether you’re moving through Fast Track, Breakthrough Designation, or Accelerated approval, we can help prepare your cold chain for regulatory scrutiny.

Are you in Phase II/III with your therapeutic?

We provide consultation on how to prepare your cold chain to meet the stringent regulatory requirements you’ll face in these review phases.

Have you received an Information Request?

We work fast to produce the robust data and reports regulators expect, heading off questions and avoiding prescriptive remedies that may not be ideal.

Is your product in the post-commercial phase?

We can optimize your supply chain by recommending improvements, conduct best practices training, or provide the transport validation data you need for annual regulatory inspections

Regeneron Case Study:

Regeneron Validated Drug Safety on Tight Timelines with 7 Plunger Movement Studies

Biologics in pre-filled syringes (PFSs) can face safety and sterility risks if the plunger moves in transit. As Regeneron prepared to file four PSF biologics with regulators, the company tapped Modality Solutions for our engineering expertise…

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Shire Case Study:

Cold Chain Engineering Helps Shire Develop a Global, Scalable Shipper Qualification Process

As Shire introduced more drug products across more countries, it became clear that a globally consistent, compliant, efficient approach to thermal packaging qualification was critical to getting to market effectively. Modality Solutions helped develop that “platform” approach…

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Our Cold Chain Engineering Makes the Difference

It takes a data-driven approach to validate your cold chain and ensure it withstands regulatory scrutiny and the rigors of the commercial supply chain. That’s what Modality Solutions provides through our unique Cold Chain Engineering capabilities. We’re the only provider that brings together every discipline needed for accurate, data-driven cold chain validation—combining the required chemical engineering, mechanical engineering, biomedical engineering, and packaging engineering expertise all under one roof.

Learn about our unrivaled Cold Chain Engineering capabilities

Expert Engineering Consulting Solutions, Customized to Your Needs

Wherever your therapeutic is along its journey to the commercial market, Modality Solutions can customize an Engineering Consulting Solution that meets your objective. Projects like these are prime examples of our highly tailored Engineering Consulting Solutions at work for leading pharmaceutical and biopharma companies:

01/ Project: Paving the Way for a Nanotherapy’s Approval

Merrimack Pharmaceuticals needed to mitigate regulatory risks during its NDA filing for MM-398, a novel nanotherapy that helps guide oncology therapeutics to the tumor site. Modality Solutions answered the call with a comprehensive Engineering Consulting Solution...

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02 / Project: Verifying and Enhancing Mixed-Load Trailer Shipments

AbbVie needed to ensure using mixed-load trailers to transport both refrigerated and room-temperature drugs was compliant with cGMP/cCDP standards and MOH expectations. Our cold chain experts evaluated the current approach, demonstrated that...

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03 / Project: Creating a Best Practice-Based Controlled Temperature Process

Janssen Pharmaceuticals needed a cold chain expert to assess its controlled temperature passive shipper process and ensure it reflected industry best practices. Modality Solutions quickly got to work—assessing current policies and procedures, identifying gaps...

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Services in our Engineering Consulting Solutions include:

  • Risk Assessments
  • Transport Validation Master Planning
  • Thermal Packaging Design and Selection
  • Drug Product Simulation Testing
  • Thermal Packaging Qualification
  • Third-Party Logistics Selection, Audit, and Quality Agreements
  • Performance Qualification Protocols and Reports
  • Regulatory Filing Submission Support
  • Information Request Assistance
  • Logistics Network Design
  • Cold Chain Optimization

A Better Approach to Plunger Movement Studies

This enhanced plunger movement study approach helps you accurately demonstrate that your therapeutic in PFSs can withstand low pressure in transit and maintain both efficacy and sterility.

For drugs transported in pre-filled syringes (PFSs), it is vital to verify plunger movement in transit doesn’t impact the therapeutic’s sterility or efficacy, per ASTM standards D4169-16 and D6653-13. But traditional plunger movement studies have limited accuracy, often require large test quantities, aren’t suitable for some devices, or involve the use of substances (like lactose powder) that can impact later Container Closure Integrity (CCI) testing.

Modality Solutions developed a better way to conduct plunger movement studies—one that’s more accurate, requires fewer syringes, is suitable for use with any device type with a visible plunger, and reduces the use of lactose powder. Testing experts at our Transport Simulation Lab capture real-time video footage of plunger movement under low pressure, simulating transport by aircraft or by truck at high elevations, and use computer software to accurately measure the degree of movement.

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