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 Pharmaplan 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
The solution was to deliver a Bio Safety Level 2 turnkey facility constructed in prefabricated modules. Thomas Meyer, Product Manager Modules, NNE Pharmaplan, 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.”

Thanks to an excellent working relationship between the client and contracting partners, the modular facility was installed on site within six days. Today, the GMP facility is Inno Biologics’ flagship, sitting proudly in a new 6,000 sq.m. complex, which also houses the company headquarters and laboratories.