Transport Simulation Solutions

You need to ensure your bulk drug substance and finished drug products will maintain their stability, sterility, and efficacy even after exposure to the hazards they’ll face in transit. Our Transport Simulation Solutions provide the answers—delivering the data you need to gain confidence in your cold chain and satisfy regulators.

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Our Transport Simulation Solutions Deliver Robust, Proven Data

Modality Solutions’ transport simulation testing is now an industry-recognized best practice and a significantly better approach than traditional methods, such as testing to the ASTM D4169 standard, used to test how transportation affects a drug formulation, from origin to destination.

As more drug formulations are protein-based large molecules or shipped in pre-filled syringes, drug stability has become an increasing concern for pharma companies and a possible obstacle to regulatory approval.

Our Transport Simulation Solutions test a drug therapy at the operating edges of your supply chain—exposing it concurrently to shock, vibration, pressure, humidity, and temperature, in worst-case conditions, to reflect the actual environment your drug will face in the supply chain.

Our Transport Simulation Laboratory is the first multi-modal lab to approach testing in this proven effective way and the only contract lab that can test for all five hazards concurrently, yielding the data you need for an efficient and successful regulatory review process.

When Our Transport Simulation Solutions are Right for Your Therapeutic

Modality Solutions provides Transport Simulation Solutions for organizations across the industry—from leading biopharmaceutical companies, to emerging biopharma companies, to the world’s largest pharmaceutical manufacturers.

No matter what stage your therapeutic is in, our Transport Simulation Solutions can deliver the accurate, robust data you need to demonstrate your product will stand up to the environmental hazards of the commercial supply chain and meet current cold chain standards.

Are you in Phase I/II?

Our transport simulation testing enables you to screen early candidate drug formulations to ensure their stability in transit, saving time and money, supporting accelerated approval timelines, and reducing the risk of a failed submission.

Are you in Phase II/III?

Our transport simulation studies help ensure your cold chain is up to the rigorous review you’ll experience during filing, delivering the data regulators expect. If you’ve received an Information Request, we’ll help you respond quickly and proactively, heading off additional questions and avoiding FDA-dictated remedies that can slow the approval process.

Are you in the Post-commercial Phase?

We can conduct transport simulation testing to determine if your cold chain needs improvement or train your staff on supply chain best practices to enhance drug stability in transit.

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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TEVA CASE STUDY:

A Comprehensive Look at Cold Chain Challenges and Solutions in a Global, Multimodal Logistics Network

TEVA needed to confirm their drug products' stability and confirm pre-filled syringes in low-pressure distribution environments were maintaining their sterile barrier...

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It All Happens in Our One‑of‑a‑Kind Transport Simulation Lab

ASTM/ISTA testing falls short because it doesn’t test your bulk or finished drug products for all hazards, concurrently and at the edge of operating space of your supply chain. Most testing services can’t fill that gap. But our Transport Simulation Lab does! We developed this unique testing environment to provide a far better approach to testing how transportation hazards will affect your therapeutic and obtaining the robust cold chain validation data regulators require.

Learn about the capabilities of our unique Transport Simulation Lab

Transport Simulation Solutions Customized to Your Needs

Modality Solutions helps organizations across the biopharmaceutical industry evaluate the hazards their therapeutics will face during transportation with our Transport Simulation Solutions tailored to each company’s specific need. From large manufacturers who need to augment their in-house testing facilities and resources, to smaller biotechs and emerging biopharmas that need a full-service Engineering Consulting solution, we provide precisely the level of support you need to satisfy regulators and gain peace of mind.

Full-Service Transport Simulation Solutions

For pharma and biotech companies that need a comprehensive approach to transport simulation, Modality Solutions crafts a custom engagement that combines the capabilities of our Transport Simulation Lab with our Cold Chain EngineeringTM solutions. From fragile therapeutics, to pre-filled syringes, to traditional oral dose formulations, we have the experience and cold chain know-how to validate your bulk or finished drug product processes against the hazards that can impact stability, sterility, efficacy, and safety.

Our customized, full-service Transport Simulation services can take you from start to finish—from conducting an initial risk assessment, to developing a validation master plan and strategy, mapping the supply chain, qualifying and selecting thermal packaging, creating simulation test protocols, conducting tests in our Advanced Transport Simulation Lab, and documenting test results. We can also ensure your staff and vendors support your cold chain at every step by evaluating supply chain partners, reviewing/developing supplier agreements, developing SOPs for pallet pack-out and other procedures, and providing staff training.

Services Include:

  • Risk Assessment
  • Transport Validation Master Planning
  • Drug Product Simulation Testing
  • Third-Party Logistics Selection, Audit, and Quality Agreements
  • Logistics Network Design
  • Cold Chain Optimization

Targeted Transport Simulation Support

Organizations with their own in-house testing capabilities often turn to Modality Solutions to supplement their resources, especially during peak times.

Our targeted transport simulation services typically focus on conducting studies that leverage the advanced capabilities of our Transport Simulation Lab, including plunger movement studies to ensure there’s no impact on PFS sterility or device functionality in transit.

We’ve helped major pharmaceutical manufacturers verify their chosen thermal packaging will maintain the required temperatures even in worst-case hazard conditions and shipping routes, assessed the suitability of their trailers for controlled temperature shipping, and developed validation master plans for their presentation to the FDA and other regulators.

Services Include:

  • Risk Assessment
  • Transport Validation Master Planning
  • Drug Product Simulation Testing

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