Modality Solutions

Modality Solutions, founded in 2011, is a leading biopharmaceutical cold chain engineering firm specializing in the validation, optimization, and regulatory approval of temperature-sensitive therapies. The company focuses on integrating cold chain operations, developing transport validation strategies, and supporting global regulatory applications for biopharmaceutical products. Modality Solutions' core offering is its unique Advantage Transport Simulation Laboratory in Bloomington, Indiana, which operates under an ISO 9001:2015 certified quality system. This lab is the only one of its kind that concurrently tests across five hazards that can impact drugs during transport: temperature, vibration, shock, pressure, and humidity.

The company's services include engineering consulting, systems integration, and simulation laboratory testing from drug discovery through distribution. Modality Solutions employs a team of chemical, biomedical, and mechanical engineers with expertise in cold chain management, package engineering, and regulatory compliance. Their approach combines best practices in process validation, systems qualification, and risk assessment to ensure product quality and patient safety. In 2021, Modality Solutions reported a 64% growth rate and was ranked No. 179 on the Inc. 5000 Regionals: Texas list. The company has also been recognized on Inc. Magazine's national list of fastest-growing private companies for three consecutive years, with a reported revenue growth of 120% between 2015 and 2018.

Key customers and partnerships

Modality Solutions serves a diverse range of clients in the biopharmaceutical industry, including emerging biopharmaceuticals, pharmaceutical manufacturers, cell and gene therapy developers, and companies working on drug-device combination products. Some of their notable clients include Teva, Immunomedics, Atara Bio, CSL Plasma, Abbott Vascular, and Regeneron. The company also works with public health organizations, assisting in the deployment of vaccines and therapeutics. Additionally, Modality Solutions collaborates with regulatory consultants and biopharmaceutical investors to provide cold chain validation services and strengthen due diligence processes for portfolio businesses.