The CBF has over 20 years experience producing biological Investigational Medicinal Products (IMPs) according to the principles of GMP for early phase clinical trials. We hold a Manufacturer’s Authorisation for Investigational Medicinal Products (MIA (IMPs)) from the Medicines and Healthcare products Regulatory Agency (MHRA), which allows us to manufacture viral vector vaccines and advanced therapy medicinal products (ATMPs), including gene and cell therapy products. All IMPs are manufactured and released in accordance with the European Clinical Trials Directive (2004). The facility can also import IMPs from outside the EU for use in clinical trials within the European Union. We aim to provide the link between academic research and clinical drug development, to allow all our collaborators to make rapid progress into clinical trials.
In this presentation I will discuss the particular challenge of the cost-effective manufacturing of novel, one-off, small batches for clinical delivery and of operating to cGMP with phase appropriate validation, using a risk-based approach. I will present some descriptions of recent analytical adoptions, and improvements to the processes that we use to manufacture adenoviral vectors, and a case study of manufacture of a new vaccine type for the CBF, with lessons learned during the tech transfer and validation phases that can be applicable to future campaigns.