Modality Solutions

Biopharma Cold Chain Engineering with State-of-the-Art Transport Simulation Laboratory

2600 S. Shore Boulevard, Suite 364, League City, Texas 77573, United States of America



Modality Solutions is a biopharmaceutical cold chain engineering firm that has worked with all sizes and types of biopharmaceutical innovators to implement and validate standardized cold chain and quality processes.

Our successes for our clients have grown to more than 75 biopharmaceutical therapies including monoclonal antibodies, immunotherapies, regenerative medicine, orphan drugs, vaccines, and combination medical devices just in the last eighteen months.

We have implemented networks in some of the most remote and inhospitable locations for biopharmaceuticals requiring controlled temperature transport logistics. Modality Solutions is committed to deliver safe drug products from manufacturing site to patients around the globe.

Our compliant cold chain validation strategies include transport validation master planning, optimal thermal packaging selection, transport simulation, product formulation testing, and optimal transport lane selection to ensure maximum results with repeatable outcomes.

Why go it alone? We can get your biopharmaceutical cold chain validated for the most stringent product specifications.

Regulatory Filing Support

Leading pharmaceutical and biotech companies are incorporating simulated transport testing of their drug formulations early on during stability forecasting at the developmental phase. We provide best practice advice in regulatory compliance and assist with regulatory agency correspondence correction to ensure timely approval.

Modality Solutions has the expertise in drug product formulation testing, thermal package engineering, and process validation to assure regulatory compliance and accelerated approval. Rising complexity of new drug formulations such as monoclonal antibodies, gene & cell therapy and orphan drugs have introduced new challenges for your cold supply chain and validation approach.

Transport Simulation Testing

Our Advantage Transport Simulation Laboratory™ has the unique ability to concurrently test for not only shock, vibration, and temperature but also pressure and humidity. These 5 transport or environmental hazards are all factors that can impact drug product quality and packaging integrity.

Based on our simulation test results we design and validate cold chain transportation for a variety of drug formulations such as monoclonal antibodies for global distribution, individualized cancer cell therapies for personalized medicine, and vaccines. Our unique technology is designed specifically to assure your drug formulation is appropriately packaged and shipped to withstand all environmental and transport exposures.

Thermal Packaging Selection, Qualification and Implementation

Our design, develop, and qualification for any active or passive thermal packaging solution is carried out by expert engineers with industry-wide recognition. Establishing and maintaining regulatory compliance with global regulations is our main focus. A process validation master plan, with protocols and reports to GDP standards, are an approach that guarantees your success.

Cold Chain Supply Logistics Operations Support

We Implement and integrate standardized cold chain operations that adhere to FDA and/or international regulations that is also compliant, efficient, robust, reliable, repeatable, and cost-effective. Let us help you design your GDP cold chain logistics network to improve compliance and reduce costs.

We provide Clinical Trial Operational Support for established cold chain logistics network that require an in-country presence with know-how, or develop one. Our experienced biopharmaceutical cold chain management experts support your team, wherever your site may be.

Integrated Expertise

Integrate our expertise into your current team. Our experts develop the standards, policies, procedures, and processes to safeguard your cold chain. Integrating with existing internal processes, leveraging present resources, and adding new skill sets where it is needed. Fill in gaps in expertise to eliminate the lengthy process of hiring in-house experts and delays in meeting aggressive project timelines.

Technology transfer and in-house training processes leave self-sufficient expert employees behind with well-rehearsed protocols and repeatable robust validation master plans. Put our expertise to work for you. Leverage our experience in regulatory compliance, package engineering, & controlled-environment logistics.

Our clients can stay focused on internal operations and growth management. Do what you do best, while we do what we do best. Our rapid adaptability within your organization will keep your operation competitive and agile. Sharing our experience will put you on the fast track to greater results and cost savings. Our engineering know-how and transport simulation technology coupled with strong process controls is the key to your success.

Working with us, you can expect:

  • Confidence in your cold chain. Guaranteed
  • Every engagement led by a principal
  • Your cold chain will be approved
  • You will become experts on your own cold chain

Contact us, we love to answer your questions. Sign up for a 60-minute free consultation with one of our leading professionals. Make sure you explore the white papers based on our experience working with industry leaders in the pharmaceutical world.

About Modality Solutions

Modality Solutions LLC, an Inc. Verified company, provides package engineering and controlled-environment logistics solutions in highly regulated industries with high-value, high-risk products. We design, calibrate, and validate your cold chain and therapies to global regulatory standards in the only independent multi-variable transport simulation laboratory in existence. Our novel transport simulation technology concurrently replicates the five (5) key environmental hazards that impact product quality as recognized by the biopharmaceutical industry and global regulatory agencies (temperature, relative humidity, shock, vibration, and atmospheric pressure).

The President of Modality Solutions, Gary Hutchinson, is a member of The Forbes Technology Council, an invitation-only community for world-class CIOs, CTOs, and Technology Executives. His membership strengthens Modality Solutions leadership role within the biotechnology cold chain management industry.

Transport Simulation Laboratory

Modality Solutions operates our Advantage Transport Simulation Laboratory™ that has been continuously validated to current GMP (Good Manufacturing Practices) since its installation in 2012.

Thermal Package Design and Qualification

The need for a standardized package qualification process was recognized by the International Safe Transit Association (ISTA) in April 2014. Modality Solutions partnered with ISTA and spearheaded this standardization process.

Clinical Trial Operations

Modality Solutions is the leader in clinical trial operations for vaccines for infectious diseases in emerging markets because we understand the challenges healthcare staff experience with proper storage and handling risks associated with temperature-controlled vaccines and biologics.

IQPC MODALITY SOLUTIONS Practical Implications

Pharmaceutical Outsourcing's Courtney Collins speaks with Modality Solutions principals Paul Harber and Dan Littlefield at the 14th Cold Chain Global Forum about the practical applications of the pharmaceutical cold chain.

Case Study: Immunomedics

Immunomedics (www.immunomedics.com) is a clinical-stage biopharmaceutical company developing monoclonal antibody-based products for the targeted treatment of cancer.

A Cold Chain Process Validation Guide

Competing priorities, changing expectations, cost pressures, sustainability initiatives, emerging markets - these are some of the challenges facing cold chain management professionals every day. Solutions that deliver value in the supply chain and enhance your regulatory reputation are required every day, around the globe.

The Challenges of Cold Chain Validation for Regenerative Medicine

Regenerative medicine is a novel biomolecular approach to exciting new clinical therapies. Generally, this grouping involves three major therapy applications: cell therapies or stem cell injections; immunotherapy, regeneration by biologically active molecules administered alone or as secretions by infused cells; and tissue engineering, transplantation of laboratory-grown organs and tissues.

Case Study: Bristol-Myers Squibb

Bristol-Myers Squibb (BMS) is a global biopharmaceutical company headquartered in New York City that specialises in discovering, developing and delivering innovative medicines for patients with serious diseases.

Optimism for DLBCL Patients Across the Globe

Last month, the FDA approved tafasitamab-cxix (official name Monjuvi®) in combination with Lenalidomide as a second-line treatment for adult patients experiencing relapsed or Refractory Diffuse Large B-cell Lymphoma (DLBCL) for MorphoSys, one of our consumers.

How AI Is Refining the Pharma Supply Chain

Artificial intelligence (AI) is guaranteed to renovate the pharmaceutical cold chain; not in the distant, proposed future, but in the following several years.

Modality Solutions Announces 2019 Year-End Milestones

Modality Solutions specializes in integrating cold chain operations, developing transport validation strategies, supporting global regulatory applications, and executing global clinical trial operations.

Webinar: A Step-by-Step Cold Chain Validation Guide

Validating your cold chain to meet and exceed increasingly stringent regulatory expectations in today’s global market is a challenge. With more than 35 international cold chain regulatory compliance guidance documents, global standards are becoming more comprehensive and increasingly complex.

Gary Hutchinson Accepted into Forbes Technology Council

Modality Solutions’ President Gary Hutchinson has been accepted into Forbes Technology Council, an invitation-only community for world-class chief information officers (CIO), chief technology officers (CTO) and technology executives.

Data Loggers May No Longer Meet FDA Regulations for Pharmaceutical Shipments

Temperature data loggers have been around for decades and were one of the first sensors in the biopharmaceutical cold chain. This technology provided temperature audit trails of shipments in transit, enabling partners in the cold chain to confirm whether the products remained within specification throughout transit and verifying the acceptability of the product for the next partner in the cold chain.

Modality Solutions Offers Formulation Testing with Transport Simulation

Full-service engineering firm Modality Solutions offers drug product formulation testing with transport simulation for drug product formulations to concurrently expose drug products to temperature, shock, vibration, humidity and pressure, as they occur during real-world distribution.

The Impact of Setting the Temperature Control Unit (TCU) to a Cycled Setting

What is the impact of the cycled setting? Modality Solutions has results to share. While running a series of controlled tests for a client, the temperature control unit (TCU) was inadvertently set to cycle mode allowing the company to compare and contrast the results of a continuous versus cycled setting.