Excellence in Facility Design or Retrofit – 2016 BioProcess International Awards
WINNER: JHL Biotech – Installation of KUBio Biomanufacturing Solution
The JHL Wuhan China manufacturing facility has been designed to support the manufacture up to 100kg of monoclonal antibodies per year in 2000L single-use bioreactors. Initially, four 2000L bioreactors have been installed. The modules were pre-built in Germany then transported to China for assembly in 8 days. The facility was operational within 18 months.
The JHL Wuhan facility design was optimized to provide efficient use of space and process flow and utilize the FlexFactory a single-use manufacturing platform so it would complement their plant in Taiwan. The standardized nature of the FlexFactory-fitted KUBio will facilitate easy scale-up from process development and early clinical manufacturing in Taiwan, to late-stage clinical manufacturing and commercial production at the new site in Wuhan. Parallel production of the KUBio modules and the FlexFactory processing equipment, during site preparations enabled JHL to reduce the overall timeline and begin production as soon as possible.
FUJIFILM DioSynth – Re-Purposing a Microbial Facility for Multi-Product GMP Manufacturing
This project involved the re-purposing and upgrading of an existing microbial GMP facility to provide self-contained cleanrooms with separate HVAC system(s) as the demand for High Potency Biologics suites are becoming an increasingly important class of therapeutics. The facility needed to be GMP ready for biologic production from vial thaw to drug substance bulk fill. Multi-product capability and versatility was critical . The retro-fit also needed to be suitable for manufacture of early/late phase clinical and commercial products. The facility design was completed in consultation with the UK regulatory agency (MHRA) to expedite regulatory approval. It took 24 months form initial concept to initiating a customer GMP run. the retro-fit facility is suited for microbial expression at the 100L volume, which supports well the high potency manufacturing scale.
Key design considerations included an initial completion of expertly detailed Failure Mode Effects Analysis (FMEA) assessments on existing procedures. From an operating principle, the following design parameters were incorporated: – Segregated “once through” HVAC system with HEPA extraction – Dedicated personnel and material access routes – Dedicated direct product contact equipment – Non-product contact equipment with disposable flow-path. From a process containment perspective, design Risk assessments (FMEA) were performed to ensure the minimization of loss of process containment.
Establishment of facility from concept to commissioning took two years and serves the unique highly potent biologic space.
Gibraltar Laboratories – CGMP Independent Lab and Sterilization Services
Gibraltar is CRO and does not manufacture. It is a 46 year scientific service organization specializing research and development and quality control. It has diversified through the integration of an existing CGMP microbiological laboratory with new steam sterilization and dry heat depyrogenation services. As a result Gibraltar is the first to offer certification, terminal sterilization and ready to use sterile vials that do not compete with CMOs.
The 24,000 sq ft, class 5-8 facility underwent extensive redesign and re-purposing of existing and new space which incorporated new technologies including: Air over pressure steam moist heat sterilization, USP water for injection. ISO classification.
Steam sterilization is a natural, safe, green and sustainable form of terminal sterilization. Renovations are more sustainable than new construction, and, in our situation it places the AOP process adjacent to the certification facilities, eliminating transportation costs. One-stop-shopping is a business strategy that is guided by sustainability. Thus, sterilization and certification is efficiently looped into manufacturing to achieve maximium efficiency while providing our customers significantly faster product turnaround times.
Now categorized as a critical vendor, Gibraltar Laboratories support aseptic manufacturers to bring new vaccines, drugs and vaccines to market with known sterilization assurance levels in compliance with FDA and USP.