eXmoor Pharma Secures MHRA License to Manufacture Cell & Gene Therapy Products
eXmoor Pharma gains MHRA license for GMP production of cell and gene therapies at its Bristol facility.
Breaking News
Aug 23, 2024
Mrudula Kulkarni
The UK's Medicines and Healthcare Products Regulatory Agency (MHRA) has granted eXmoor Pharma, a company that offers cell and gene therapy manufacturing services, a Manufacturing and Import Authorisation for Investigational Medicinal Products (MIA(IMP)) licence. With this license, eXmoor is able to produce cell and gene therapy materials that meet good manufacturing practice (GMP) standards in preparation for clinical trials. The licence was granted after a thorough examination of eXmoor's Cell & Gene Therapy Centre in Bristol, a cutting-edge establishment intended for the production of cutting-edge medicines. The facility has numerous autologous cell therapy stations per suite and up to two 200L bioreactors, making it suitable for the production, optimisation, and scaling up of cell therapies, RNA treatments, and viral vectors. The Cell & Gene Therapy Centre uses only heat pumps and solar technologies as part of its commitment to sustainability.
With the MIA(IMP) license, eXmoor Pharma enters a new phase
of expansion, providing a full range of development, manufacturing, and
professional consulting services to assist developers of cell and gene therapy
from the research stage to the commercialisation stage. With the goal of
swiftly and readily increasing cleanroom capacity, eXmoor plans to extend GMP
activities to a key and commercial size within the facility when new
collaborations are formed. One of the biggest of its type in the UK, the Cell
& Gene Therapy Centre is prepared to start production right away. GMP and
quality teams are in place, and over the next 18 months, there will be a
considerable demand for its capacity from customers.