Research Ensures Pharmaceutical Safety and Efficacy
Temperature, light, humidity, and duration can each have a negative impact on the safety and efficacy of a drug substance or formulated drug product. The priority of the MRIGlobal team that leads our repository and stability facility is to enable thorough analysis of these drug materials across varied conditions, ensuring the development of safe, efficacious pharmaceuticals.
This facility houses 20 chambers that span all possible storage conditions, including Refrigerated (+2ºC to +8ºC), Frozen (≤ -20ºC), Ultra Cold (≤ -80ºC), or Climate Controlled (25ºC/60%Relative Humidity [RH], 35ºC/60%RH, 40ºC/75%RH), and also includes an oven for controlled degradation studies. The stability chambers are also programmable to provide customized storage conditions to meet any study requirements that a client may have. Additionally, the entire facility is designed and tested to ensure it maintains Controlled Room Temperature of +20ºC to +25ºC to allow for stability study conditions to be provided on large open shelving areas.
Housed in the same building as our repository and biorepository, our 3,500 square foot pharmaceutical stability facility in North Kansas City, Missouri serves the many commercial and government clients who rely on us to support complex multi-storage temperature studies, or multi-storage temperature/humidity studies. The stability studies performed in this facility are used to generate evidence on how the quality of a drug substance or formulated drug product varies with time under the influence of a variety of environmental factors.
For our pharmaceutical clients, this facility provides efficiency and convenience, coupled with our unmatched reputation for quality in everything we do.
