Procedures are in place to support QA Batch Release and QP Batch Certification for cell banks, drug substance and drug product lots for use in clinical trials.
RoslinCT holds a Manufacturer’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. We also hold an ISO:9001:2015 accreditation, which applies across the business. On-going maintenance of these licences allows the provision of a comprehensive range of manufacturing services for cell-based products destined for clinical trial.
In order to apply for a clinical trial application in one or more European Union Member States, the Investigational Medicinal Product Dossier (IMPD) is one of several regulatory documents required. The corresponding application to the FDA in the United States for an Investigational New Drug (IND) application, similarly emphasises the utilisation of the principles of a Quality by Design approach to determine the critical aspects of pharmaceutical manufacturing quality.
The regulatory submissions include summaries of information related to the chemistry, manufacturing and control (CMC) of any IMP. Regulatory support can be provided by RoslinCT to ensure product compliance and adoption of appropriate strategies for regulatory submission, maximising the chance of early success.