Inno Biologics's BSL2 facility for mammalian cell-based therapeutic proteins and monoclonal antibodies is the first GMP-compliant biotech facility in Malasia. NNE helped the customer meet its need for a fast-track project and flexible processes.
Inno Biologics needed a biotech production facility that met European and US-FDA GMP regulations. The company had recently been incorporated by the Ministry of Finance, who wanted to make the biotech industry a major source of growth for the Malaysian economy – and the project was given top priority.
Inno Biologics needed a partner with extensive experience of GMP regulations, who could execute the project in modular construction. The company turned to NNE for consultancy, from review of basic design to final qualification.
Meeting challenging requirements
The facility, which produces mammalian cell-based therapeutic proteins and monoclonal antibodies, had a number of challenging requirements. It had to be completely cGMP-compliant, and was constructed in a short timeframe. At the same time, the facility had to be flexible. One example is the bioreactors, which can be used as both storage tanks and fermenters. In addition, it was very important to Inno Biologics, as a contract manufacturer, that the equipment was produced and engineered to US and EU standards.
Modular solution for flexibility and reliability
NNE's solution was a biosafety level 2 (BSL2) turnkey facility constructed in prefabricated modules. NNE's Product Manager Modules explains why: “The client chose the modular approach not only because of the flexibility it gives, but also because the equipment and systems could be installed and pre-tested in Europe in a controlled environment before shipment. This ensured that it met the client’s high quality standards.”
The client chose the modular approach not only because of the flexibility it gives, but also because the equipment and systems could be installed and pre-tested in Europe in a controlled environment before shipment. This ensured that it met the client’s high quality standards.
Inno Biologics Sdn. Bhd.
Jan. 2006 – Apr. 2007 (on site)
GMP risk analysis, review of basic design, detailed design, procurement, delivery of a modular turnkey production plant, construction and installation management, commissioning supervision, qualification