INDIANAPOLIS, June 18, 2012 /PRNewswire/ -- Sentry BioPharma Services, a provider of global biopharmaceutical cGMP storage, supply chain management, prescription drug distribution and clinical packaging services, announced today the addition of a -45C 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, notes, "The highly customized -45C freezer enhances Sentry's ability to serve global biopharmaceutical clients' clinical sites through a single depot location centrally located in North America. Recently, a large, publicly held biotechnology company selected Sentry based upon our proven track record of success, our robust quality management system, pristine regulatory compliance record and expertise as the premier provider of clinical supply depot services. Further, Sentry identified a strong need within its European client base for clinical trial depot and API management services at this crucial temperature setting." Mitchell continues, "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 -45C freezer next month," says Dwayne Marcum, Sentry's chief operations officer. Marcum adds, "Upon completion, the 1,200 square foot chamber will complement Sentry's existing ambient (15C to 25C); refrigerated (2C to 8C); frozen (-15C to -25C) and ultra low (-70C to -90C) environments. The -45C 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."
Since incorporating in 2005, Sentry has always embraced an innovative approach to solving technical challenges by offering tailored, high-quality services among the most stringent international regulations. Sentry's on-demand services continue to reliably offer pharmaceutical and biotechnology companies with superior service, immediate regulatory compliance, speed to market and a high probability for a successful project outcome.
About Sentry BioPharma Services
Sentry BioPharma Services maintains cGMP temperature-controlled storage for vaccines and other biopharmaceutical product, controlled substances III – V, FDA labeling capability, drug distribution licenses and an active Foreign Trade Zone status to exclusively serve the global pharmaceutical, biotechnology and healthcare industries. Its facilities, infrastructure and services are specifically designed to meet the cGMP warehousing, labeling, packaging, cold chain logistics and contract service needs of pharmaceutical and biotech firms, health care providers and suppliers, contract research organizations (CROs), contract manufacturing organizations (CMOs), wholesalers, distributors and governmental entities.
Sentry's management team offers expertise in pharmaceutical cold chain storage and logistics, quality assurance, biopharmaceutical packaging and kitting development. Sentry also offers strategic solutions for global transportation and logistics, as well as end-to-end import and export management.
The company's validated processes and inventory tracking systems are FDA compliant, adhere to current Good Manufacturing Practices (cGMPs) and comply with the stringent standard operating procedures (SOPs) outlined in Sentry's Validation Master Plan. Sentry is VAWD® accredited, which ensures its storage, handling and distribution methods meet the recognized guidelines of the National Association of Boards of Pharmacy®. The company is privately held and strategically headquartered in Indianapolis, Indiana.
SOURCE Sentry BioPharma Services