We recognized a critical gap in the industry.
Life sciences leaders Gary Hutchinson and Dan Littlefield recognized that large‑molecule biologics — one of the fastest growing therapy types — posed unique cold chain challenges. To gain approval for biologics and other advanced therapies, small and mid‑sized biopharmaceutical companies needed specialized cold chain engineering and regulatory expertise. Their in‑house capabilities were a good start, but typically they weren’t enough.
Gary and Dan watched these companies struggle to get all the necessary cold chain expertise from a single source. Most tried to piece together services from multiple firms or independent contractors, which proved ineffective and inefficient.
So we created a unique, multi‑disciplinary cold chain engineering firm.
In 2011, Gary and Dan leveraged their extensive engineering, supply chain, and regulatory experience to found Modality Solutions — a firm that combines the unique skills, expertise, and capabilities needed to bring advanced therapeutics to rapid, successful approval. Modality Solutions is the only provider to bring it all under one roof: validation engineering, regulatory guidance, advanced testing, and cold chain optimization.
At the core of our capabilities is our independent, ISO‑certified Advantage Transport Simulation Laboratory™ in Bloomington, Indiana. It’s the only lab of its kind that concurrently tests across the five hazards that can impact drugs during transport: temperature, vibration, shock, pressure, and humidity. Other labs don’t even come close (testing fewer hazards, not concurrently, which isn’t what happens in the real world).
By the Numbers: A Look at
Modality Solutions’ Impact
Since our founding, we’ve put our mark on the industry in a big way, with an exceptional track record of success across a large, diverse group of therapies.
Biologics, advanced therapies, and drug-device combination products supported
- 80% of the therapies we’ve supported are FDA Accelerated/Fast Track pathway drugs with rigorous cold chain demands
- Biologics, cell & gene therapies, combination drugs, antibody-drug conjugates (ADCs), and other advanced pharmaceuticals are our specialty
Successful global regulatory interactions
- 75+ drug approvals since 2018
- Global regulatory experience: US, EMEA, NMPA, and ANVISA
- Unique transport simulation capabilities, facilitating most of the successful regulatory interactions for our clients
Successful thermal packaging qualifications
- Using manufacturer data to confirm suitability in your specific lanes
- Filling data gaps through technical assessments and testing
- Providing PQ shipments for thermal packaging verification only
- Optimizing the cold chain through least-cost routing and packaging design and selection
2 major public health, humanitarian initiatives
- 0 doses lost in the cold chain across public health initiatives using our clinical trial operations in emerging markets
- Vast experience with Ebola vaccines and treatments
- Partnerships with NIH, CDC, BARDA, CROs, and industry sponsors
Key cold chain regulatory guidance documents
- PDA Technical Reports, ISTA Standards and Manuals, ISPE Good Practice Guidance, and URAC Cold Chain Accreditation authorships/contributions
- Up to date on the latest regulatory guidelines globally, including 40+ life sciences cold chain guidance documents worldwide.
It’s How We Satisfy Our Clients
“We are very delighted to inform you the FDA has approved tafasitamab. On behalf of the whole team, we want to thank you for your great support. Well done!”
“Modality Solutions developed the distribution validation strategy for our antibody-drug conjugate. They drafted all required protocols, supported the validation execution, and finalized all reports. Modality Solutions’ hard work resulted in the regulatory authority's approval and acceptance of the distribution validation. Team members Brian and Rachel were hardworking, responsive, and dedicated to the success of this effort.”
Meet Our Cold Chain Experts
Our top-notch team of experts is led by Modality Solutions co-founders Gary Hutchinson, president, and Dan Littlefield, principal and head of engineering. Every project engineer holds a degree in chemical, biomedical, or mechanical engineering. A certified project manager leads every project. And every engagement benefits from a team with diverse skill sets across a range of disciplines, including Certified Six Sigma Master Black Belts.