INDIANAPOLIS, Oct. 2, 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 successful launch of a -45C environmental room in order to serve 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, "At the BioPharm America 2012 Conference in Boston, MA last week, the highly customized -45C freezer emerged as Sentry's most intriguing service offering available to global biopharmaceutical clients' clinical sites. Of the numerous one-on-one meetings with biotech firms, many expressed an interest in Sentry's -45C freezer capacity and in Sentry's global distribution capabilities. We currently have 70 percent of our -45C freezer capacity under long term contracts and we are in discussions with large pharma for additional contracts which would necessitate the construction of another -45C freezer. As the biotech and pharma industry continues to evolve, maintaining proteinaceous API at customized temperatures has become a crucial mission for Sentry."
"Sentry completed validation of the -45C freezer as planned," says Dwayne Marcum, Sentry's chief operations officer. Marcum adds, "The -45C environmental room's operational performance exceeded my start-up expectations with no mechanical failures and no temperature excursions even through the defrost cycle. Most other ultra low temperature systems hit the defrost cycle and go out of temperature for a given period. Sentry's system does not. The equipment was specially designed and installed to continuously operate within +/-5C with triple redundancy, using state-of-the art refrigeration, temperature monitoring and controlling systems to provide optimal product safety and efficacy. The 1,200 square foot chamber complements Sentry's existing ambient (15C to 25C); refrigerated (2C to 8C); frozen (-15C to -25C) and ultra low (-70C to -90C) environments."
Since commencement of operations in 2006, Sentry has always embraced an innovative approach to solving technical challenges by offering tailored, high-quality services meeting and exceeding 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