What We Do

Modality Solutions is a privately owned biopharmaceutical cold chain engineering firm that supports fast track regulatory approval for biologics and specialty drugs. Our expertise in validation engineering and cold chain regulatory guidance is unmatched.

Our unique transport simulation methodology is executed in the only contract testing laboratory for biological therapies that concurrently simulate the five main environmental hazards: temperature, shock, vibration, pressure, and humidity.

Accurate and repeatable transport simulation at the edges of your design space allows:

• The characterization of drug product formulations

• The confirmation of chemical and physical drug product stability

• The assessment of package performance during transport in simulated ‘real world’ conditions.

Our advanced concurrent testing has become the leading approach that redefined the way industry tests specialty drug and biologic therapy formulations. Our subject-matter experts provide insight into thermal packaging, transport validation, and controlled-environment logistics globally.

Modality Solutions has been conducting regulatory compliant cold chain site assessments and improvements for vaccines for humanitarian use.

• The Mitchell Group (TMG) and Leidos Biomed, Ebola Treatment Centers in the Democratic Republic of Congo

• National Institute of Allergy and Infectious Diseases (NIAID) Ebola vaccine in Democratic Republic of Congo.

• FHI 360 and CDC clinical trials for Ebola vaccine in Sub-Saharan Africa, Sierra Leone

• Leidos Biomed and NIAID in 2016, Liberia, Ebola vaccine