Bharat Biotech, Vaccine Production Plant, Perak, Malaysia

With the ascendancy of the Indian pharmaceutical and biotech industries has come expansion, and even in some cases foreign investment into new facilities. Bharat Biotech is one Indian company with the foresight to invest in other areas of Asia and this will be its first plant on foreign soil. Bharat Biotech International Limited (BBIL) specialises in developing and manufacturing vaccines and bio-therapeutics.

The new facility is being constructed on a 6ha Greenfield site in Perak, Malaysia but with significant aid from the Malaysian government in the form of tax incentives and grants. Malaysia has excellent resources and an investment-friendly environment, which includes government assistance for the biotech sector.

The company will use the new plant to manufacture a chloride-free hepatitis B vaccine, but will later use some of the plant’s capacity to manufacture other vaccines for malaria and typhoid, hormone for diabetic foot ulcers and cardiovascular drugs.

Bharat already has one of the largest biotech manufacturing facilities in Asia at its headquarter facility in Genome Valley, Hyderabad (Thurkapally) in India. The multi-product biological facility has a floor space of 350,000ft² and can produce a vast range of biotech products in commercial quantities, with reactors ranging in size from 50l to 20,000l. Its milestones were the development of the chloride-free hepatitis B vaccine, indigenously produced probiotic yeast and also patented HIMAX technology-higher recover of surface antigen proteins.

PARTNERSHIP AND CONSTRUCTION

In 2005 Bharat Biotech entered into a memorandum of understanding with Remco Engineering and Consultancy and Perak Development Corporation (PDC), for setting up its first overseas unit in Malaysia. Bharat Biotech is extending its technical expertise and Remco will build and outfit the plant. PDC owns the land. The plant will help BBIL penetrate into the Middle East and Asian markets, particularly Indonesia. The plant is expected to start commercial production by June 2007.

The new manufacturing plant will be constructed in Perak, Seri Iskandar Pharmaceutical Park, Malaysia at a cost of MYR50m (US$13.23m). The new plant will include an R&D facility and a manufacturing building, with areas for fermentation vessels, media preparation, downstream processing and purification. There will also be an administration block, QA and QC laboratories, a plant-room and a packaging and warehousing area. There will be a utility block for chiller units, cooling tower, tank farm, waste handling and plant facilities.

PRODUCTS AND THE FUTURE

Although the new plant will initially only produce a hepatitis B vaccine, the plant is being designed to take up production of other vaccines and also for the manufacture of a range of other biotech products as they progress through the company’s drug pipeline. BBIL is keen on developing therapeutic products such as recombinant lysostaphin and recombinant vascular endothelial growth factor. The company filed an IND (investigational new drug application) for recombinant lysostaphin at the end of September 2005, making it the first biotech molecule in India for which an IND has been filed.

Cardiovascular disease is a major problem in the Western world and BBIL’s new product Recombinant Streptokinase-Indikinase is set to be a first-line therapy for myocardial infarction; this product may eventually be produced at the new plant. The company is also in the advanced stages of development for a rabies vaccine. More vaccines including combination vaccines are in the pipeline. DPT + hep B + Hib combination vaccines are planned. Probiotics and growth factors are also recognised as two further promising areas for the company. Eventually the therapeutic products and vaccines parts of the business will be equal.

PREVIOUS PROJECT

In 2003 BBIL signed an agreement with Mvelaphanda Holdings of South Africa to set up a biotech facility in a 50:50 joint venture near Johannesburg, but this has not yet come to fruition. The two partners are still working out the financing and several complex issues behind the project.

The South African government is still keen to pursue the project. Technology issues and manpower requirements are some of the aspects on which the partners are working out their strategies. It looks as if Malaysia has stolen the project at this particular time although negotiations are still going on with South Africa and a second plant may follow in the future.