CPI’s RNA Centre of Excellence passes major milestone with GMP certification
07 Feb 2024
This first-of-its-kind RNA manufacturing facility offers end-to-end support to pharmaceutical companies in manufacturing new therapeutics and vaccines for use in clinical trials.
CPI’s RNA Centre of Excellence, which opened last year, has passed a critical step after achieving GMP certification from the Medicines and Healthcare products Regulatory Agency (MHRA), bringing the facility closer to getting new, more effective drugs to patients with incurable or hard-to-treat illnesses.
The demand for RNA-based technology has boomed since the success of COVID-19 vaccines in saving lives and preventing serious illness. RNA-based therapeutics have many more potential applications: in other vaccines, in cancer treatments, and in personalised medicines, such as gene therapies and protein replacement.
The £26.4m RNA Centre of Excellence is the UK’s only open-access facility which can produce lipid nanoparticle-encapsulated messenger and self-amplifying RNA vaccines and therapies.
To use the products clinically in the UK, including in clinical trials, medicines manufacturing facilities must comply with Good Manufacturing Practice (GMP) to meet a minimum standard in their production processes. GMP compliance minimises pharmaceutical manufacturing risks and ensures that products, medicines, and vaccines are safe, of consistent high quality and appropriate for their intended use.
Following a successful inspection by the UK Medicines and Healthcare products Regulatory Agency (MHRA), the Centre has been granted a Manufacturer’s Licence (MIA (IMP)) and a Certificate of GMP Compliance of a Manufacturer.
The licence enables CPI to support its partners in the complete RNA therapeutics journey – from process development and scale-up, to manufacturing medicines and vaccines for clinical trials. This is a key milestone for CPI in supporting its partners and for meeting the increasing demand for clinical evaluation of this emerging technology.
The RNA Centre of Excellence provides CPI’s partners with much-needed infrastructure and expertise. To illustrate its capacity, the Centre can deliver 100 million vaccine doses in the event of a future health emergency.
With the GMP compliance certification, the Centre is set to take even greater leaps in bringing innovative and novel treatments to patients together with partners in the industry,
Dave Tudor, Managing Director, Medicines Manufacturing Innovation Centre, Biologics & Quality at CPI said:
“Getting GMP certification is a huge milestone for CPI, and our staff, as we look to enhance our ability to produce safe and effective RNA treatments and therapies. Innovations in RNA therapies have the potential to transform how we treat many incurable and hard-to-treat diseases today and in the future, and they will play a central role in the way we deliver healthcare in the future.
“This certification puts the RNA Centre of Excellence and the UK at the forefront of medical advances within RNA technologies.“
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