OVERALL CONCEPT
INITIAL LINE
NEW FACILITY AT A GLANCE
Four-stream gene therapy and other ATMP sterile fill-finish facility( BSL1 and 2)
CAR-T therapies in glass injection vials
Planning permission was secured in July 2026 and as of the end of October 2026 the building envelope has been constructed and is watertight. Nova currently targets first commercial manufacturing activity in the first quarter of 2028, subject to successful project completion and regulatory approval.
CORE TECHNOLOGY
QUALITY BY DESIGN
TARGET
Automated filling, stoppering, crimping and robotic handling across a threeisolator process Grade A processing, first-air protection, particulate control and Annex 1 considerations First commercial manufacturing activity in Q1 2028, subject to completion and regulatory readiness
Automation on the first line includes fully robotic vial handling, filling, stoppering and crimping intended to improve repeatability while reducing gloved interventions close to exposed product. Three positive-pressure isolators connect the process: the first for thawing and pooling material ahead of sterilising filtration; the second for concentration and automated sterile fill-finish and the third for flash-gassing decontamination of finished vials and optional transfer. By considering product pathway, robotics, filtration, first-air protection, airflow and transfer functions as one connected system, Nova is designing contamination control into the process rather than adding it around existing machinery. The design features address Grade A processing, particulate control, airflow visualisation and compatibility with Nova’ s sporicidal gassing process, and all align with current EU GMP Annex 1 expectations.
A Lifecycle Partnership
Nova’ s operating model extends beyond equipment and cleanrooms. Multidisciplinary teams include formulation development, analytical, microbiological, engineering and manufacturing disciplines, supported by clinicaltrial labelling, packaging and QP release. Projects can move from small scale clinical batches of 200 vials to fully automated runs of up to 20,000 vials, removing the risk and disruption of changing partners as demand grows. Dedicated project leads, qualified in aseptic processing, provide a single point of contact from early development through to full commercialisation. For customers developing high-value biological products, the new facility will offer additional UK-based capacity backed by an unusual depth of practical engineering control. For Nova, it represents the next chapter in a story defined by industry firsts: applying scientific expertise, bespoke technology and collaborative problem-solving to bring pioneering medicines safely to patients. The work to commission, qualify and validate the new facility is substantial, but the direction is clear – towards a flexible, resilient manufacturing platform built for the opportunities presented by cell and gene therapies.
From concept to qualified operation
The new facility is being designed around the process, with controlled personnel and material flows, dedicated goods-in and goods-out areas, storage, changing and technical spaces. New HVAC, electrical distribution, drainage, water and supporting services will underpin the Grade C classified environment. Solar panels will provide up to 50 % of the building’ s day-to-day power requirements and heat-recovery on air handling systems will reduce energy usage and further strengthen Nova’ s green credentials.
Visit our website www. novalabs. co. uk
+ 44( 0) 116 223 0100 info @ novalabs. co. uk
Nova Laboratories Ltd, Martin House, Gloucester Crescent, Wigston, Leicester, LE18 4YL