Case Studies

This project involved the design of a GMP manufacturing suite designed to prepare Master and Working Cell Banks for the production of Biotechnology/Biological products derived from mammalian cells.

The new Virus Spiking Suite generally comprises the following accommodation: 

•    Cell Culture Lab (approx. 20m2)

•    Virus Titration Lab  (Approximately 17m2) 

•    Virus preparation Lab (approx. 19 m2) 

•    Interconnecting corridors and lobby areas (approx. 22m2)

The labs generally contain recirculated microbiological safety cabinets, CO2 Incubators and fridges/freezers.  The suit is generally to be constructed to ACDP Containment Level 2. 

This project was a new multipurpose biological API cGMP production facility with associated support laboratories, complete with cGMP warehousing.

We were engaged to carry out the design and build of the facility, taking over at the design concept stage from an Architect. Our design team, worked closely with the client groups to develop the design for this facility and construction delivery.  This process involved detailed user review meetings, the production of process, critical Utility and utility process and instrument diagrams, the development of detailed Room Data Sheets, Room and equipment layouts, Clean Room envelope HVAC and M&E design to form the basis of an overall Detail Design brief.  The design development also coordinated and responded to the MHRA as part of the licensing process.

To meet project time scales a pre-used building was identified, surveyed for suitability and purchased by OXB. This allowed for minor building modifications and immediate installation of the mezzanine level, plant areas, clean room fit out and utility plus HVAC and building services installation. The key process equipment was single use disposable technology, procured in parallel to the clean room build. 

The facility and equipment as set out in an overall Validation Master Plan was subject to an extensive Commissioning and validation process.