SMC Ltd., a solutions provider in the manufacturing of pharmaceutical and medical devices, announces the opening of Cambridge Pharma, a new business offering pharmaceutical development services, including sterile fill-finish.
The new 20,000 sq ft facility, located at the Cambridge Research Park, UK, includes a purpose-built sterile fill-finish facility, a process development laboratory and an analytical laboratory. Services include process development and scale up, sterile fill finish for clinical trials, QC and stability testing and QP release of clinical trials supplies.
Chetan N. Patel, owner and CEO of SMC Group, has a strategic vision for the company: “We 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 ‘Cambridge Pharma’ as a part of our continued focus, growth and commitment to pharmaceutical products and services.”
The sterile fill finish facility is designed to meet up-to-date regulatory requirements and includes a state-of-the-art dynamic and independent HVAC systems and two clean rooms. Each clean room is equipped with isolators and fill finish equipment to support batch sizes from 100 units to 15,000 units in vials, cartridges, or syringes. Cambridge Pharma’s industrialisation engineers can take a customer’s laboratory scale formulation and develop a process for clinical trials in phases one to three including process development and filling of viscous formulations, suspensions, and gels. Nonstandard primary drug containers can be accommodated, and container closure integrity tests and associated equipment can also be developed.
The experienced QC and QA teams can undertake stability and QC testing and the QPs can release clinical trial supplies. Cambridge Pharma project managers ensure program schedules are respected to meet pharma companies target trial start dates.
Barbara Lead, Cambridge Pharma CEO, said: “I am really proud of our new facilities and the experience and expertise of our teams. 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.”
Tim Holden, Cambridge Pharma’s commercial director, added: “Our 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.
"Specialising in this service ensures that development timelines can be minimised, and cost savings can be made by our customers. We are very proud that our new facility has eco-friendly features which means we can help Pharma and Biotech companies meet their sustainability targets too.”