Transportation hazards affect drug product quality and efficacy.
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.
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.
Modality Solutions operates our Advantage Transport Simulation Laboratory™ that has been continuously validated to current GMP (Good Manufacturing Practices) since its installation in 2012.
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.
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.
Pharmaceutical Outsourcing's Courtney Collins interviews Modality Solutions Principals Paul Harber and Dan Littlefield at the 14th Cold Chain Global Forum.
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.
Immunomedics (www.immunomedics.com) is a clinical-stage biopharmaceutical company developing monoclonal antibody-based products for the targeted treatment of cancer.
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.
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.
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.
A Proven Approach to Ensure Success.
Houston-based biopharmaceutical cold chain validation engineering firm Modality Solutions is thrilled to declare it made the Houston Business Journal’s 2020 Fast 100 rankings of the city’s fastest-growing privately held companies for the second year in a row.
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.
Covid-19 and the Race to Get a Vaccine Through FDA’s Supercharged Fast Track Approval Named Coronavirus Treatment Acceleration Program (CTAP)
The Coronavirus Treatment Acceleration Program launched by the FDA in response to Covid-19 is a Supercharged Fast-Track Approval process that reduces the Fast-Track Approval timeline from 18 months to as soon as possible in order to get treatment to the patients as fast as possible.
Clinical trials around the world are being disrupted by the Covid-19 pandemic, leaving sponsors with no choice sometimes but to suspend some trials and delay others.
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, a leading biopharmaceutical cold chain engineering firm, is pleased to announce it achieved its ISO 9001:2015 registration by certification body Intertek.
Biosimilars have been a point of contention within the pharmaceutical industry for the past 30 years.
Modality Solutions specializes in integrating cold chain operations, developing transport validation strategies, supporting global regulatory applications, and executing global clinical trial operations.
2019 saw a resurgence of antibody-drug conjugates (ADCs) with seven new approvals and close to 100 investigational ADCs currently in pre-clinical and clinical trials.
With five FDA programmes moving drugs through approval to commercialisation, the speed of scale-up is quickening, shortening time to market by months.
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.
Modality Solutions, a biopharmaceutical cold chain engineering firm, is pleased to announce it made its first appearance on the Houston Business Journal’s Fast 100 list. Modality Solutions ranked No 91 with reported two-year revenue growth of 56%.
Biopharmaceutical cold chain engineering firm Modality Solutions is pleased to announce it ranked No 3094 on Inc Magazine’s annual Inc 5000 list, one of the most prestigious rankings of the nation’s fastest-growing private companies.
Over the course of the last decade, the use of drones has been trialled for use in expanding the ability of supply chain professionals to deliver temperature-sensitive drug therapies and life-saving vaccines.
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.
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 is a biopharmaceutical cold chain engineering firm with regulatory filing authorities, logistics network experts, and experienced integrated staffing professionals.
Immunotherapies are an increasingly complex set of treatments for a wide variety of diseases and medical conditions.
Modality Solutions has announced it will be a silver sponsor and exhibitor at Executive Platforms’ Biomanufacturing World Summit (BMWS).
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.
Modality Solutions is participating as both a Silver Sponsor and exhibitor at this year’s Executive Platforms’ Biomanufacturing World Summit (BMWS).
Modality Solutions cold chain experts recently published and made available its new Cold Chain Process Validation Guide.
Cold chain experts Modality Solutions have published and made available for free its new white paper, ‘Drug Product Formulation Testing with Transport Simulation’.
Robert Battista is a consulting engineer at Modality Solutions.
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.
Modality Solutions’ president Gary Hutchinson and principal Daniel Littlefield will be attending and participating in the American Biomanufacturing Summit.
Modality Solutions has announced the transformation of Modality-Solutions.com into an engaging, content-rich, all-device compatible website.
Modality Solutions has announced that it will be sponsoring and presenting at the 15th Annual Global Forum - Temperature Controlled Life Science Supply Chains.
Modality Solutions has hired Robert Battista as consulting engineer, expanding its team of cold chain management experts.
Modality Solutions’ Daniel Littlefield Leads Roundtable Discussion at 17th Annual World Vaccine Congress (WVA), Washington
Modality Solutions has announced its sponsorship and roundtable leadership at the 17th Annual World Vaccine Congress (WVA) in Washington, DC.
Integrated cold chain management solutions provider Modality Solutions has announced its sponsorship and presentation at this year's Global Cold Chain Exchange.
Modality Solutions is pleased to announce its bronze sponsorship and panel participation at the 9th Annual Bio Supply Management Alliance (BSMA) Forum titled 'Preparing the Biotech Supply Chain for 2025, The Onward March'.
Modality Solutions to Sponsor and Present at 14th Annual Cold Chain GDP & Temperature Management Logistics Global Forum
Cold chain management solutions company Modality Solutions has announced it will sponsor one of the largest events for temperature controlled life science supply chains, 14th Annual Cold Chain Management Logistics Global Forum.
Modality Solutions has hired Andrew Larrigan as consulting engineer, which involves writing proposals and reports for a distribution and thermal testing.
Life-sciences contract service provider BioConvergence has rebranded as Singota Solutions to respond to its client's needs.
The role of Technical Consulting Engineer at Modality Solutions has been given to Hannah Anderson, who is currently helping to provide company’s pharmaceutical clients with program management of its thermal package engineering services.
Modality Solutions’ Gary Hutchinson Joins Shipper Perspectives on the Cold Chain Panel at TPM Annual Conference
Modality Solutions is pleased to announce that president Gary Hutchinson will be a panelist at the 16th Annual Trans-Pacific Maritime (TPM) Conference in Long Beach, California from 28 February to 2 March.