Cambridge Pharma has opened a plant in the Cambridge Research Park, UK, which includes a 20,000 square-foot fill-finish facility.
The facility, of which financial details have not been disclosed, also includes a process development laboratory an analytical laboratory and will deliver process development, sterile fill-finish for clinical trials, stability testing and release of clinical trial materials.
Cambridge Pharma is a part of SMC, a contract manufacturer of single use and disposable medical devices. The firm claims that its fill-finish facility has been designed to meet regulatory requirements and includes two clean rooms as well as independent heating, ventilation, and air conditioning (HVAC) systems.
‚ÄúWe value pharmaceutical partnerships and continue to expand services in development, manufacturing, and analytical testing to help accelerate drug product development. We are proud to launch ‚ÄėCambridge Pharma‚Äô as a part of our continued focus, growth and commitment to pharmaceutical products and services,‚ÄĚ said Chetan Patel, Owner and CEO of¬†the SMC group.
The clean rooms have isolators and fill-finish equipment with the ability to support batch sizes from 100 units to 15,000 units in cartridges, vials, or syringes. According to Cambridge Pharma, its industrialisation engineers will be able to take clients laboratory scale formulations to develop a process for clinical trials from Phases I to III. This includes process development and filling of suspensions, gels, and viscous formulations.
Furthermore, primary drug containers have the ability to be accommodated, and container closure integrity tests and equipment can also be developed. The firm‚Äôs quality control and quality analytical teams will undertake stability and testing to release clinical trial supplies.
‚ÄúOur principal aim is to meet the challenging schedules Pharma clients face when planning clinical trial supplies. Our process development laboratory means we can support this, it certainly gives us an edge in completing timely technology transfer. We have the equipment and facilities designed specifically for smaller flexible manufacturing runs. Specializing in this service ensures that development timelines can be minimized, and cost savings can be made by our customers,‚ÄĚ said Tim Holden, Cambridge Pharma‚Äôs commercial director.