Manufacturing

We expect to be operating at Good Manufacturing Practice (GMP) standard in mid 2026,  to provide material for customers at all stages of the translational research pipeline from proof-of-concept to material for Investigational Medicinal Products (IMPs) at early stage clinical trials.

Our state-of-the art clean room facility will offer:

• optimised stirred tank bioreactor processes to manufacture clinical grade adeno-associated viral vector (AAV);
• in house platform processes;
• variable batch sizes up to 50 litres;
• vial fill and finish service including inspection, labelling, and packaging.

Quality Assurance 

At the centre of our operations is our Quality Assurance (QA) department.  QA hold overarching responsibility for delivering patient safety and product quality at the centre.  Functioning independently of the other departments, the team maintain regulatory compliance and provide QP release certification.

Quality Control

The Quality Control (QC) department provides in-house testing to both the manufacturing and process development departments.  The team ensure the environmental integrity of our clean rooms and the quality of our product in compliance with MHRA expectations for sterile and controlled manufacturing environments.  This is achieved by:

• environmental and microbiological monitoring of the facility;
• testing of raw materials, intermediates, and finished products by in process checks ;
• release testing to verify product quality  compliance with pre-defined specifications.