King’s College London (KCL) expanded their existing facility to support the development of new genetic treatments with funding from King’s College London and the EU’s European Regional Development Fund (ERDF). The expanded £5.8m facility was delivered within a live environment and will now operate as one of the largest suppliers of Good Manufacturing Practice (GMP) grade viral vectors supporting clinical trials across Europe.
Project Scope
The Gene Therapy Vector Facility (GTVF) is a state-of-the-art facility that adheres to the stringent standards established by the Medicines and Healthcare Product Regulatory Agency (MHRA). As one of Europe’s leading suppliers of GMP-grade viral vectors for clinical trials, the GTVF offers the following:
- Lentiviral Vector
- Retroviral Vector
- Adeno-associated Viral Vector
Key Features
- Refurbishment works: With two laboratories on the second floor of the Rayne Institute being stripped out prior to full fit-out creating two Grade C cleanrooms. A refurbishment of the changing area accommodated the facility’s enhanced service capabilities.
- Storage conversion: The existing storage area was consolidated into one functioning suite.
- New microbiology laboratory: Will be used for routine environmental monitoring activities and assessment of incoming microbiological media.
Our Role
- User Requirement Specification (URS): Development of URSs for Facility, HVAC, EMS, Isolator, and Gases by actively collaborating with KCL End Users to define and document the specific requirements for the GTVF, ensuring alignment with scientific needs, safety standards, operational efficiency, and GMP regulations.
- Facility & Equipment Qualification Plan (FEQP) and Validation Plans (VPs): Development of comprehensive FEQP and VPs to outline the validation strategy and procedures to ensure compliance and reliability.
- Design Qualification (DQ) and Requirements Traceability Matrix (RTM): Development and review of the DQ and RTM to ensure that all user and regulatory requirements were appropriately addressed and traceable throughout the design and implementation phases.
- Installation Qualification (IQ): Generation and review of IQ protocols and reports to verify that equipment and systems were installed in accordance with approved design specifications and manufacturer recommendations.
- Operational Qualification (OQ): Review of OQ protocols and reports to confirm that systems and equipment operate as intended under all anticipated conditions.
- Technical Advice: CCTech provided expertise during layout development and subsequent design stages ensuring the facility will achieve MHRA compliance.
- Procurement Support: Assisting with Main Contractor and Specialist Subcontractor selection.
- Isolator and EMS Procurement: Facilitating the acquisition process.
- Isolator and EMS Qualification: Review of rigorous testing and validation followed by a wraparound document.