January 10, 2012 -- Norwich, a leader in full-service contract development and manufacturing, is expanding its services to now include small scale feasibility and initial product development for prescription and over-the-counter pharmaceuticals. The non-GMP development facility will offer Norwich customers greater flexibility and speed when assessing the feasibility of technical concepts and formulations, and create streamlined progression from clinical into scale-up and through commercial manufacturing.
Norwich’s comprehensive product development capabilities include formulation, analytical method development and validation, process optimization, and scalable manufacturing. The state-of-the-art, non-GMP facility is comprised of an analytical laboratory designed for potent compound handling, and a development area enabling formulation and product transfer verification. The company also has a pilot plant for technology transfer and small-scale manufacturing.
“Establishing feasibility and initial product development capabilities fills a significant unmet need for customers who are seeking a complete range of services from a contract provider. It also underscores our focus to build a robust capability for all stages of the product lifecycle,” said Chris Calhoun, president of Norwich Pharmaceuticals.
The product development unit is led by Dr. Robert E. O’Connor, PhD, vice president of product development and technical services, who has more than 30 years of domestic and international pharmaceutical experience. Before recently joining Norwich Pharmaceuticals, Dr. O’Connor was the vice president of product support for Johnson & Johnson, where he served in a leadership capacity since 2003. A registered pharmacist and Certified Six Sigma Black Belt, Dr. O’Connor received his PhD in pharmaceutics from the Philadelphia College of Pharmacy and Science.
“With these new capabilities, we are now able to move directly from initial product development into our existing GMP pilot plant for process optimization, clinical supply manufacturing and submission batch production,” indicated Dr. O’Connor. “Our experienced team has the expertise and resources to convert a concept into a feasible formulation ranging from liquids to solid dose, including immediate and extended release delivery systems.”
Throughout the development process, the team utilizes a full range of small-scale, specialized machinery. Primary equipment in the development suite includes a 25-liter high shear granulator, 16-liter low shear granulator, 12-liter fluid bed with a 6-inch Wurster column, four- to sixteen-liter v-blenders, 10- to 50-liter bins and bin blender, a 10-station rotary press, and impact and rotating impeller mills. The pilot plant also features state-of-the-art equipment, including a 75-liter high shear granulator, 140-liter low shear granulator, 57-liter fluid bed with a 12-inch Wurster column, 2- and 3-cubic foot v-blenders, 20- to 600-liter bins and bin blender, an 18-station rotary tablet press, a 400-cpm capsule filler, various side vented coating pans, impact and rotating impeller mills and a roller compactor.
“With specialized equipment, a state-of-the-art facility and an experienced team, Norwich is streamlining the development process and optimizing our ability to offer higher levels of uncommon value for our customers,” said Calhoun.
About Norwich Pharmaceuticals
Norwich Pharmaceuticals is a full-service contract development and manufacturing provider for Rx and OTC pharmaceuticals. From clinical services through commercial launch, Norwich applies more than 100 years of experience and an unparalleled compliance record to the development, manufacture, packaging and distribution of solid dose, semi-solid, and liquid pharmaceutical products. Visit www.norwichpharma.com for additional information.
