Malaysia, often viewed as a manufacturer of low-cost consumer items, is moving to become a supplier of higher-value biotech products. Accordingly, the Malaysian government invested in the infrastructure to build Inno Biologics, a CMO for biopharmaceuticals in Nilai, Negeri Sembilan.
In 2006, Inno Biologics, a subsidiary of Inno Bio Ventures, opened Malaysia’s first cGMP-compliant production facility that meets European and U.S. standards for biologics manufacturing. Inno Bio Ventures is also involved with diagnostics, stem cells, and setting up a biotech science park.
Inno Biologics’ services encompass gene cloning and expression in CHO cells and novel cell expression systems, bioprocess development, and cGMP biopharmaceutical manufacturing. By offering effective platforms for manufacturing biopharmaceuticals at a low cost, “we hope to make biologics available to more people in the world,” says Nazlee Kamal, Ph.D., CEO.
In one of its latest partnerships, Inno Biologics signed a strategic licensing agreement with Cevec Pharmaceuticals. Cevec’s Amniocyte Production (CAP™) cell line is based on human amniocytes, it reportedly offers stable and higher expression of human proteins than conventional cell lines.
Inno Biologics will further develop the nononcogenic CAP expression system and use it to produce safe and effective biopharmaceuticals. “In theory, a human cell line should produce glycosylated proteins that are fully human, and there should be fewer side effects when injected into patients,” notes Dr. Kamal.
The CAP cell line is particularly suited for manufacturing mAbs. “CAP will become a challenger to CHO cells, the current workhorse of the industry,” predicts Dr. Kamal. Additionally, Inno Biologics and Cevec are co-developing several other platform technologies that benefit both companies.
Inno Biologics is using Boehringer Ingelheim’s expression systems, to develop and manufacture biopharmaceuticals for preclinical and Phase I and II trials. When a drug candidate advances past Phase II trials, manufacturing shifts to Boehringer Ingelheim facilities to produce larger batches. “The tech transfer process is our responsibility,” says Dr. Kamal. “The customer does not have to worry about the headaches of scaling up manufacturing.”
In collaboration with the Center of Molecular Immunology in Havana, Cuba, Inno Biologics is pursuing humanization strategies for therapeutic mAbs. The technology minimizes the risk of immune rejection of therapeutic proteins when injected into patients, according to the partners. Two molecules that are markers for colorectal cancer have been fully humanized and patented by the Center of Molecular Immunology, which is devoted to basic research, product development, and production of mAbs and recombinant proteins. Inno Biologics plans to begin testing the humanized molecules in animal studies later this year.
Closer to home, Inno Biologics teamed up with CCM DuoPharma, a Malaysian drug company, to develop and market EPO. By manufacturing EPO in Malaysia, “we will be able to reduce the price and increase the number of patients who will have access to the drug,” Dr. Kamal says. The overall goal is to provide an affordable supply of EPO to people in Malaysia and neighboring countries.
Inno Bio Diagnostics is a tissue culture laboratory for stem cell research. Located at the University Kebangsaan Malaysia Medical Center, the laboratory develops stem cell methods for use in cell-based therapies and regenerative medicine. Among the firm’s projects are preclinical studies with cardiomyocytes to repair heart disease damage. Collaborations are being pursued with companies in Europe, India, and Australia to advance stem cell research.
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.”