Cambridge, UK – SMC Ltd., a leading solutions provider in pharmaceutical and medical device manufacturing, announces the opening of Cambridge Pharma, a new business offering pharmaceutical development services, including filling- sterile finish. The new 20,000 square foot facility located at Cambridge Research Park, UK, includes a purpose-built sterile fill-finish facility, process development laboratory and analytical laboratory. Services include process development and scale-up, sterile fill finish for clinical trials, quality control and stability testing, and QP release of clinical trial 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 development, manufacturing and analytical testing services to help accelerate the development of pharmaceutical products. . We are proud to launch ‘Cambridge Pharma’ as part of our continued focus, growth and commitment to pharmaceutical products and services. »
The sterile filling finishing facility is designed to meet the latest regulatory requirements and includes 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 batches of 100 units to 15,000 units in vials, cartridges or syringes. Cambridge Pharma’s industrialization engineers can take a customer’s lab-scale formulation and develop a process for clinical trials in phases one through three, including process development and filling of viscous formulations, suspensions and gels. Non-standard primary drug containers can be accommodated, and container closure integrity testing and related equipment can also be developed.
Experienced QC and QA teams can undertake stability and QC testing and QPs can release clinical trial supplies. Cambridge Pharma project managers ensure that program schedules are adhered to to meet pharmaceutical companies’ target trial start dates.
Barbara Lead, CEO of Cambridge Pharma, 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 have experience with difficult to fill formulations. Our goal is to provide excellent customer service for clinical trial supplies that are still on the critical path to market.
Tim Holden, Commercial Director of Cambridge Pharma, added: “Our primary focus is to meet the challenging timelines that pharmaceutical customers face when planning supplies for clinical trials. Our process development lab means we can support this, it certainly gives us an edge to do timely technology transfer. We have the equipment and facilities specifically designed for small flexible manufacturing runs. Specialization in this service ensures that development times can be minimized and cost savings can be realized by our customers. We are very proud that our new facility has environmentally friendly features, which means we can also help pharmaceutical and biotech companies achieve their sustainability goals.
Further information :
Cambridge Pharma Limited
Barbara Lead / Tim Holden
+44 (0)1223 736 221
+44 (0)20 3633 1730 / +44 (0)7733 301 707
About Cambridge Pharma Limited
Cambridge Pharma Ltd. specializes in providing the safest sterile pharmaceutical products for clinical use and small scale needs. They offer a fast and flexible fill-finish service specifically designed to meet the needs of clinical trials and stability studies, including process development, stability testing and QC analysis. Internal expertise will support the development of new drugs, from the preclinical phase to commercialization. Their state-of-the-art GMP facility, located in the heart of Europe’s largest biotech and pharma cluster, features intelligent and dynamic cleanroom control that helps pharmaceutical companies achieve their environmental sustainability goals.
About SMC Group
SMC Group includes SMC Ltd., Oval Medical Technologies Ltd. and Cambridge Pharma Ltd. With over 34 years of medical manufacturing experience and facilities in California, Wisconsin, Massachusetts, Ohio, UK, India and Costa Rica. SMC Group provides contract manufacturing services to the medical device and diagnostics industries and “end-to-end” integrated services for the clinical and commercial manufacture of combination products for pharmaceutical customers. Visit us at www.smcltd.com, www.ovalmedical.com and www.cambridgepharma.com. For more information, visit www.cambridgepharma.com.