Major capital investment by the New York-based company Norwich Pharmaceuticals has led to the addition of high potent compound capabilities.
In the past, Norwich has concentrated its efforts on providing contract services to manufacturing along with packaging services.
The company has recently invested over US$3 million in infrastructure, controls and the specialised equipment necessary to support pilot scale clinical trial material (CTM) for the manufacture of high potent compounds, including fast dissolve and controlled release tablets, said Norwich vice-president, technical & development services, Carolyn Gherardi.
"In addition to the capital investment in physical infrastructure, we've put together an outstanding technical team," said Gherardi. "Our people are capable of manufacturing high potent products in a variety of dosage forms and providing a range of analytical services in-house. And, along with the considerable addition of dedicated equipment, we've also increased our staff of highly-qualified specialists to assure consistent performance and rapid response to potential problems."
The potent compound development facility at Norwich features an HVAC system designed for 20 room air changes per hour, utilising redundant HEPA filtration to eliminate any possibility of cross-contamination. Separate personnel ingress/egress airlocks, with a separate equipment and materials airlock, provide full containment of compounds. The Norwich facility also has a dedicated control system to monitor and regulate the environmental conditions of every development suite.
The expansion into potent compound development supports the Norwich's plan to increase its role in biopharmaceutical development as more and more manufacturers seek state-of-the-art outsourcing services.