What does having GMP certification mean in practice?

Developing new medicines and treatments at scale is vital to respond to pandemics like COVID-19 but also to treat serious illnesses and save lives. 

Our RNA Centre of Excellence in Darlington, UK, can play a major role in these efforts, with the capacity to manufacture millions of vaccine doses per year in the event of a future health emergency. And it just passed another important milestone. 

The Centre recently received a Certificate of Good Manufacturing Practice (GMP) from the UK Medicines and Healthcare products Regulatory Agency (MHRA). Along with our manufacturing licence, this critical compliance milestone enables CPI to provide end-to-end support to our partners in meeting the booming demand for RNA technology and in developing transformative treatments for currently incurable diseases. 

But what does GMP certification mean in practical terms, particularly in the context of the pharmaceutical industry? How exactly does it support RNA innovation? 

What is GMP?

GMP is the minimum standard that a medicines manufacturer must meet in their production processes. The MHRA and the European Medicines Agency (EMA) publish guidance on GMP, which they inspect manufacturers against, to ensure new pharmaceutical products are safe. 

In the UK, GMP is governed by the UK MHRA, to ensure new pharmaceutical products are safe, of consistent high quality and suitable for their intended use. Medicine manufacturing facilities like our RNA Centre of Excellence must comply with these standards to manufacture investigational medicinal products, for use in clinical trials and, ultimately, to be used in treating patients. 

The outcome of our initial inspection was a success, and the UK MHRA will carry out regular subsequent inspections as part of the Risk Based Inspection Programme to ensure we continue to comply with the rules. 

Supporting the full clinical journey

GMP certification allows CPI to support our partners throughout the entire RNA journey. As well as working with them to develop and scale up medicine manufacturing innovations, our in-house scientists can now produce batches of investigational medicines and vaccines for use within clinical trials. Ultimately, this means that we can help partners take their ideas all the way from concept to the production line, which provides continuity as well as a streamlined development process, de-risking the move to IMP by avoiding timely and costly technology transfer. 

As demand for RNA technology soars, the streamlined process that the Centre facilitates will be particularly valuable, both for commercial and research partners. It enables them to respond to, and evaluate, new health challenges quickly and remain at the cutting edge of a fast-moving sector. 

This is particularly important for mRNA-based medicines as many researchers are shifting towards evaluation of candidates in humans, owing to the limitations of animal models, which, despite remaining the gold standard, suffer from poor prediction of human immunogenic response. 

Facilitating global operations and collaboration

As well as allowing the production and use of new RNA-based therapeutics in the UK, GMP certification enables CPI to make an impact on an even wider scale. 

This is important for two key reasons. It facilitates international collaboration in the development of new medicines and treatments, better enabling UK innovators to work on joint ventures with counterparts elsewhere. At the same time, it helps our partners to take another step towards exporting their products to international markets, driving investment into this vital sector. 

With GMP compliance secured, the Centre can make an even greater impact in empowering RNA innovation and developing new treatments for the patients who need them most. 

If you’d like to find out more about how we can offer end-to-end support for a project within RNA technology, reach out to me below.