State-of-the-art facility enables companies to compete in global biopharmaceutical markets
Partnerships with major foreign firms endorse BioNexus-status firm as it starts to make an impact in a competitive field

Adherence to strict international standards is crucial to success in the highly regulated international biopharmaceutical industry. Compliance with the industry standard, known as current Good Manufacturing Practice, extends to every aspect of the process involved in the production of drugs and medical devices, and requires the use of up-to-date technologies and systems – hence the “c” in the short form cGMP. Versions of cGMP are applied by regulators all over the world.

Malaysia’s first cGMP modular biopharmaceutical production plant was established less than two years ago by Inno Biologics (InnoBio), a Malaysian Ministry of Finance incorporated company with a close affiliation to the Ministry of Science, Technology and Innovation, launched in 2006.

The state-of-the-art facility, built to conform to US Food and Drug Administration (FDA) and European Medical Agency (EMEA) standards, has the capacity to produce 1,000 litres of drugs a day, and did not come cheap. Constructed in Germany by Pharmaplan International, it was shipped to Malaysia and assembled on the company’s site in Nilai, Negeri Sembilan, at a total cost of $26 million – paid for by loans and government grants.

It is money well spent, however, enabling InnoBio, which is one of Malaysia’s BioNexus-status firms, to compete in global markets as a manufacturer of clinical grade biopharmaceutical products.

Mohd Nazlee Kamal Group Managing Director of InnoBio

Mohd Nazlee Kamal, Group Managing Director, sums up the company’s philosophy. “We are committed to finding more cost-effective ways to produce drugs without compromising quality so that they can be available in the market at a reasonable price,” he says.

Among the company’s competitive advantages, he lists a strong focus on R&D, a highly skilled and dedicated staff and its strategic location inside Malaysia. “We can offer customers a very good way of developing their products and getting them to the market faster.”

InnoBio has already secured partnership agreements with several international firms. “We have several potential big pharmaceutical projects in the pipeline. Hopefully we can secure more contracts and form more partnerships,” says Dr Mohd Nazlee.

Current ventures include a RM140 million deal (£21 million) with Indian drug developer Avesta Biotherapeutics & Research to produce biopharmaceuticals over a five-year contract term. InnoBio has also paired up with Germany’s Boehringer Ingelheim, one of the world’s top 20 pharmaceutical groups, giving it access to its German partner’s manufacturing technology platform for cell culture products, including the state-of-the-art BI HEX cell expression system.

Another project the company is working on is a biological-based drug for the treatment and diagnosis of colorectal cancer, which it hopes to bring into the market by 2013, and which Dr Mohd Nazlee says will be between 30 and 50 per cent cheaper than other drugs.

Links with Cuba’s Centre of Molecular Immunology, from whom InnoBio has licensed a technology called ‘humanisation technology of antibody’, are aimed at enhancing the development of novel antibody drug and therapeutic vaccines. The research will involve local entities such as Nuclear Malaysia, Universiti Kebangsaan Malaysia’s Medical Biotechnology Institute, Institute of Medical Research, Universiti Sains Malaysia, Malaysian Bio-diagnostics Research, and National Institute of Nutraceuticals and Pharmaceuticals.

Collaboration with UK-based GE Healthcare gives InnoBio preferred access to some of its larger partner’s key technologies. The two sides will also conduct joint training and development, which will further boost the Malaysian firm’s position and identity in the multi-billion dollar global biotech contract manufacturing business.