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May 15, 2010 (Vol. 30, No. 10)

Malaysian CMO Sees Itself as Regional Vanguard

Inno Biologics on Quest to Help Establish Country as a Premiere Biomanufacturing Hub

  • Modular Construction

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    The company specializes in mammalian cell culture technology. Its cGMP facility was built to comply with EMEA and U.S. FDA requirements.

    NNE Pharmaplan designed the cGMP production plant at Inno Biologics. The modular, two-floor biopharmaceutical manufacturing facility took two years to complete. Pharmaplan International first constructed the various modules in Germany where they were tested and inspected to ensure adherence to international standards for cGMP manufacturing. Then the entire facility was deconstructed, shipped to Malaysia, and reassembled.

    “We did this because there were no local companies experienced in the design and construction of a biopharmaceutical plant,” explains Dr. Kamal.

    Once the modules arrived in Malaysia, installation of the manufacturing plant took just three weeks, including setting up production suites, HVAC, water treatment, and technical features. The new plant houses Inno Biologics headquarters, laboratories, and support facilities.

    The modular design allows the company to grow according to market and industry demand, and it can even be relocated with ease. The facility is equipped with 200 L and 1,000 L bioreactors, cleanrooms, and technology for perfusion, hybrid expanded bed absorption, and disposables. Up to 50 people will work in the facility.

    Inno Biologics’ BioNexus status has helped drive its growth. BioNexus is a key element of the Malaysian government’s biotechnology policy that was launched in 2005. This national initiative offers a number of benefits to companies like Inno Biologics that are involved in research and development, including tax exemptions, various grants, and removal of restrictions on employing expatriates.

    “Biotechnology is very new in Malaysia,” says Dr. Kamal. “But it is a good country to do business in. Malaysia is the hub of Asia, and there is a lot of interactions between East and West as companies look for new markets. Malaysia can be seen as a springboard for doing business in Asia.”

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