The contract manufacturing firm SMC Ltd. has opened a new pharmaceutical development subsidiary known as Cambridge Pharma in Cambridge Research Park.
The Cambridge Pharma facility will include sterile fill-finish offerings, a process development laboratory and an analytical laboratory. The company can fill batches of 100 to 10,000 units.
It also will offer process development, scale up services, quality control and stability testing. In addition, the new location will offer Qualified Person (QP) release of clinical trial supplies.
The 20,000 ft² facility is located less than 10 miles away from the city center of Cambridge, UK.
“We value pharmaceutical partnerships and continue to expand services in development, manufacturing and analytical testing to help accelerate drug product development,” said Chetan N. Patel, owner and CEO of SMC Group. “We are proud to launch ‘Cambridge Pharma’ as a part of our continued focus, growth and commitment to pharmaceutical products and services.”
The Cambridge Pharma sterile fill finish facility is designed to meet current regulatory requirements. It is equipped with dynamic and independent HVAC systems and two clean rooms. Each clean room has isolators and fill-finish equipment to support batch sizes ranging from 100 units to 15,000 units. The fill-finish facility supports vials, cartridges and syringes.
Cambridge Pharma has industrialization engineers who can support customers’ laboratory-scale formulation and develop a process for Phase 1 to Phase 3 clinical trials.
The plant can accommodate nonstandard primary drug containers.
Cambridge Pharma can also develop container closure integrity tests and associated equipment.
“I am really proud of our new facilities and the experience and expertise of our teams,” said Barbara Lead, Cambridge Pharma CEO, in a statement. “We can provide a range of pharmaceutical development services and we have experience with difficult to fill formulations. We aim to provide an excellent service to customers for clinical trial supplies which are always on the critical path to market.”
The larger Cambridge Research Park spans 150 acres and 1.7 million ft² of high technology and laboratory buildings.