Sentry BioPharma Services has added a -45°C environmental room to its cGMP facility in order to accommodate clients in need of clinical trial depot services and bulk cGMP storage. The expansion increases Sentry's capacity to warehouse and distribute temperature-sensitive pharmaceutical products including APIs, intermediates, clinical trial materials and commercial drug products.
Tim J. Mitchell, Sentry's president, commented, "The highly customized -45°C freezer enhances our ability to serve global biopharma clients' clinical sites through a single depot location centrally located in North America. Further, Sentry identified a strong need within its European client base for clinical trial depot and API management services at this crucial temperature setting. By further building Sentry's risk management approach to the specialized handling of temperature-sensitive biopharmaceutical products, we are better able to assist our clinical trial clients in devising and implementing custom secondary labeling, packaging configurations and depot service solutions at Sentry's headquarters. This investment strengthens Sentry's position as a leader in the biopharmaceutical industry and contributes to new market expansion."
"Sentry will complete validation of the freezer next month. Upon completion, the 1,200-sq.-ft. chamber will complement Sentry's existing ambient (15°C to 25°C); refrigerated (2°C to 8°C); frozen (-15°C to -25°C) and ultra low (-70°C to -90°C) environments. The -45°C environmental room is unique in that it was specially designed and built to continuously operate with triple redundancy, using state-of-the art refrigeration, temperature monitoring and controlling systems to provide optimal product safety and efficacy, according to a Sentry statement.