Bilex Pharma is delighted to announce a significant operational milestone: our state-of-the-art vaccine manufacturing facility in Manchester has received full regulatory approval from the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) for commercial Good Manufacturing Practice (GMP) production.
A Landmark Achievement in Operational Readiness
This approval confirms that our Manchester facility, operations, and rigorous quality management systems meet the stringent standards required for the commercial production of human vaccines within the United Kingdom. Located in Trafford Park, the 15,000 square meter facility represents a cornerstone of Bilex Pharma’s strategy to build integrated, end-to-end vaccine development and manufacturing capabilities entirely within the UK.
The MHRA’s approval follows comprehensive inspections and validation processes, verifying the facility’s design, equipment, personnel training, quality control procedures, and overall compliance with GMP regulations essential for ensuring product safety, efficacy, and consistency.
Validating Investment and Expertise
“Receiving MHRA approval for our Manchester site is a landmark achievement for Bilex Pharma and a testament to the dedication and expertise of our manufacturing, quality, and technical operations teams,” said Dr. Andras Ottlik, CEO of Bilex Pharma. “This validates our significant investment in establishing world-class manufacturing capacity in the UK and demonstrates our capability to produce vaccines meeting the highest regulatory standards.”
The facility, which employs over 200 highly skilled professionals, features adaptable production lines capable of handling multiple vaccine platforms, dedicated quality control laboratories, pilot-scale development areas, and advanced cold chain management systems.
Supporting Late-Stage Pipeline and Future Commercialisation
Achieving commercial GMP readiness is a critical step as Bilex Pharma advances its vaccine pipeline towards potential market authorisation. This approval ensures that we have the certified capacity to:
- Supply pivotal clinical trials: Reliably produce materials for ongoing late-stage studies, including our Phase 3 trial for the RSV vaccine candidate, BLX-RSV01.
- Prepare for potential commercial launch: Be operationally prepared to manufacture and supply vaccines upon receiving marketing authorisation.
- Support multiple candidates: Provide manufacturing flexibility for various candidates within our diverse pipeline, utilising different technologies like mRNA and protein subunits.
Sarah Williams, Vice President, Manufacturing and Operations at Bilex Pharma, commented: “This MHRA approval is the culmination of years of meticulous planning, construction, validation, and operational execution. Our team has built not just a facility, but a robust quality culture and operational excellence framework designed for reliable, high-quality vaccine production. We are incredibly proud to reach this milestone and are fully prepared to support Bilex Pharma’s mission.”
Strengthening UK Vaccine Capabilities
The establishment and regulatory approval of the Manchester facility reinforce Bilex Pharma’s commitment to the UK life sciences ecosystem. Alongside our research centres in Cambridge and Oxford, and technical operations in Glasgow, the Manchester site completes an integrated network designed to accelerate vaccine innovation from discovery through to global supply. This investment contributes significantly to the UK’s sovereign capabilities in vaccine manufacturing and pandemic preparedness.
Looking Forward
With MHRA approval secured, the Manchester facility is now fully operational for commercial GMP vaccine production. This pivotal achievement positions Bilex Pharma strongly for the next phase of growth, ensuring we have the internal manufacturing capabilities necessary to bring our innovative vaccines to patients in the UK and worldwide, pending regulatory approvals of the vaccines themselves.
About Bilex Pharma
Bilex Pharma is a UK-based biotechnology company dedicated to advancing human health through groundbreaking research and innovative vaccine development. Our mission is to protect communities worldwide by combating infectious diseases and emerging health threats with safe, effective, and accessible vaccines, leveraging cutting-edge platforms including mRNA, viral vectors, and advanced adjuvant systems.