Modality Solutions Cold Chain Management Systems
Modality Solutions specialises in the implementation of cold chain management systems for the pharmaceutical industry.
Thermal packaging for pharmaceuticals
Modality Solutions offers cold chain thermal packaging qualification and transport validation, as well as logistics in regulated and controlled pharmaceuticals, biologics, and combination medical device industries.
The company integrates your quality management systems, risk management, product stability requirements and validation activities. Data gained from this can be provided on the impact of environmental hazards to quality attributes of any product.
Modality Solutions offers product characterisation, process validation, monitoring, and controls, as well as clinical trial operations.
Safeguarding services for supply chains
Modality Solutions has more than 100 combined years of cold chain experience. The company’s team develops the necessary standards, policies, procedures, and processes to safeguard the security of a product’s supply chain.
Innovators, research-based developers, and scientists consider safeguarding their cold chain as an important step in reducing regulatory risk, while decreasing the product approval time.
Modality Solutions guarantees:
- Appropriate expertise and techniques to assess, control, and communicate risk as part of an ongoing management review process
- A lifecycle approach to process validation including design, qualification, and verification
- Better integration of product formulation, controlled environment logistics, and packaging design
- Innovative quality control, corrective and preventive actions (CAPA) strategies, and root cause analysis
- The application of technology to achieve gains in compliance, quality, and safety
Transport simulation laboratory for studying environmental hazards
With Modality Solutions’ unique transport simulation laboratory, users concurrently study environmental hazards of drug formulation such as temperature, shock, vibration, pressure and humidity.
The laboratory is an independent, third-party transport simulation facility. It meets good manufacturing practice (GMP) standards for all types of packaging and formulations.
Users can compare results against expiry date stability studies, which verifies that the candidate product formulations are able to withstand the demands of the international supply chain.
Modality Solutions offers thermal packaging design and qualification processes to lessen or eliminate transportation environmental hazards in the supply chain.
The company ensures regulatory compliance, product quality, and safety during clinical trials and into commercial distribution. All solutions are integrated, holistic, and practical, compared with traditional packaging companies.
Cold chain logistics and transportation validation
The company helps clients with regulations and compliance for cold chain management and has substantial experience in design, validation, implementation, and monitoring in this area.
Numerous factors can affect a product’s efficacy and stability through shelf-life. Increasing regulatory scrutiny on a worldwide supply chain process controls means more product and process data will be needed to show that stress induced during transport does not impact quality or shelf-life.
Modality Solutions designs and validates cold chain controlled-environment logistics solutions. The company provides validation master plans, documented protocols and reports, and a summary for Niologic License Application (BLA) or marketing authorisations worldwide.
Pharmaceutical clinical trial operations
Clinical trial management provides various advantages such as medical and clinical monitoring, product safety, and project handling. Modality Solutions establishes a collaborative relationship with clients to deliver fast, successful, and scientifically sound clinical trial logistics deliverables.
Ongoing monitoring, staff training, and data query resolution is available, as well as drug supply accountability and regulatory document preparation, review, and collection.
About Modality Solutions
A privately owned company, Modality Solutions provides engineered solutions for highly regulated industries.
Since its founding, Modality Solutions has helped more than 75 leading life science and biotechnology companies integrate their cold chain management systems.
Modality Solutions has contributed to a wide range of publications, including Life Science Leader, PharmaVOICE, Pharma Logistics IQ, Cold Chain IQ, Pharmaceutical Online, Pharmaceutical & Medical Packaging, Pharmaceutical Outsourcing, World Trade WT100, Supply Chain Brain, Healthcare Packaging, Pharmaceutical Commerce and Specialty PHARMA Journal.
Products and Services
Clinical Trial Operations
Modality Solutions specialises in depot monitoring for vaccine clinical trials and provide operational and technical support to CDC-sponsored projects.
Cold Chain Logistics with Transport Validation
Modality Solutions designs and validates cold chain-controlled environment logistics solutions, including validation master planning, thermal profiles and process validation.
Three-in-One Cold Chain Experts
Working with Modality Solutions gives clients the distinct advantage of having three firms integrated into one.
Thermal Package Design and Qualification
Thermal package design engineering and qualification experience is necessary to maintain product quality and ensure regulatory compliance.
Transport Simulation Laboratory
The Advantage Transport Simulation Laboratory™ concurrently studies the impact of temperature, humidity, pressure, shock and vibration.
IQPC MODALITY SOLUTIONS – Traditional Thermal Shippers
Pharmaceutical Outsourcing's Courtney Collins interviews Modality Solutions Principals Paul Harber and Dan Littlefield at the 14th Cold Chain Global Forum.
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: Shipping Validation to Assess the Impact of Transportation Hazards
Achaogen is a South San Francisco-based biopharmaceutical company with expertise in the discovery, development and commercialisation of new antibacterial drugs, particularly products that treat multi-drug resistant (MDR) gram-negative
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.
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.Read more
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.Read more
Modality Solutions is a biopharmaceutical cold chain engineering firm with regulatory filing authorities, logistics network experts, and experienced integrated staffing professionals.Read more
Modality Solutions has announced it will be a silver sponsor and exhibitor at Executive Platforms’ Biomanufacturing World Summit (BMWS).Read more
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.Read more
Modality Solutions is participating as both a Silver Sponsor and exhibitor at this year’s Executive Platforms’ Biomanufacturing World Summit (BMWS).Read more
Modality Solutions cold chain experts recently published and made available its new Cold Chain Process Validation Guide.Read more
Cold chain experts Modality Solutions have published and made available for free its new white paper, ‘Drug Product Formulation Testing with Transport Simulation’.Read more
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.Read more
Modality Solutions’ president Gary Hutchinson and principal Daniel Littlefield will be attending and participating in the American Biomanufacturing Summit.Read more
Modality Solutions has announced that it will be sponsoring and presenting at the 15th Annual Global Forum - Temperature Controlled Life Science Supply Chains.Read more
Modality Solutions has hired Robert Battista as consulting engineer, expanding its team of cold chain management experts.Read more
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.Read more
Integrated cold chain management solutions provider Modality Solutions has announced its sponsorship and presentation at this year's Global Cold Chain Exchange.Read more
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'.Read more
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.Read more
Modality Solutions has hired Andrew Larrigan as consulting engineer, which involves writing proposals and reports for a distribution and thermal testing.Read more
Life-sciences contract service provider BioConvergence has rebranded as Singota Solutions to respond to its client's needs.Read more
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.Read more
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.Read more