Our facilities are specifically designed to deliver cell and gene-based therapeutic products and cell banks for clinical trials. The cleanroom space is divided into fully flexible Grade B cleanroom suites with Grade A cabinets allowing for secure aseptic processing. Grade C cleanroom space and analytical and microbiological testing laboratories are designed to provide the support services required to demonstrate GMP compliant processing methods and procedures are conducted.
We have proven experience in delivering GMP grade products from a wide variety of cell types isolated from various different starting materials. Cell culture and expansion can be accommodated in systems ranging from small scale culture wells to flasks to cell culture bags to cell factories to bioreactors and automated cell culture systems. Irrespective of scale, your manufacturing process will be established to ensure that the critical control points are monitored to demonstrate the product maintains its critical quality attributes throughout the complete manufacturing process. A product-specific analytical testing programme will be qualified to ensure product quality is prioritised.
We utilise an in-depth understanding of advanced cell therapy manufacturing methods and current good manufacturing practice guidelines to ensure the delivery of a regulatory compliant product to meet your clinical timelines and budget. We show commitment to working to the highest quality standards and provide reliable yet flexible and accommodating expert services to accelerate the route to market for your products.
We hold an Importer’s Authorisation for Investigational Medicinal Products (MIA(IMP)) from the Medicines and Healthcare products Regulatory Agency (MHRA), for Advanced Therapy Medicinal Products (ATMPs) and a licence from the Human Tissue Authority (HTA) or the procurement, testing, processing, storage, distribution and import/export of human tissues and cells intended for human application.