The first Philippine-made anti-rabies serum (ARS) is expected to become commercially available by the first half of 2007 as Servac Philippines Corp. (SPC) has secured a P200-million venture capital from an established local infrastructure investor.

It will take six to eight months from the release of the fund to establish the facilities to be set up by SPC in Gingoog City, Misamis Oriental. It will have a capacity of 400,000 doses per year and will be a Good Manufacturing Practice (GMP)-certified facility.

While refusing to identify the venture capitalist, SPC President and Chief Executive Officer Danilo P. Manayaga said the investor has wide exposure in Philippine business, mainly in infrastructure and power generation.

"The venture capital will finance the whole package. We no longer need to get a DBP (Development Bank of the Philippines) loan," Manayaga said in an interview.

The technology will substitute for the country’s importation of anti-rabies vaccine as soon as the SPC facility complies with the quality standards set for pharmaceutical manufacturers by the World Health Organization (WHO) and the Bureau of Food and Drug.

"WHO foresees a permanent global shortage and high prices of rabies immunoglobulin. That’s why it encourages local production of ERIG (equine rabies immunoglobulin)," he said.

The Philippines currently imports anti-rabies vaccine from Korea, US, France and other European countries.

Once SPC starts commercial production, the Philippines can also export the product to China, India, Africa, and Latin America whose death rate from rabies infection are among the highest in the world.

With the fund, SPC will beef up its horse inventory to at least 200 horses. At a 400,000 dose capacity, the ARS facility will import substitute a P2-billion worth of vaccine even as vaccine treatment now costs P5,000 per case. The Department of Health’s (DoH) Research Institute for Tropical Medicine (RITM) earlier approved SPC’s ARS technology.

It has earlier been tested for efficacy, purity, animal assay (potency, safety, pyrogenecity), microbiology, and virus detection (Elisa).

The ARS also went through pre-clinical tests done in 2004 including an animal challenge study looking at survivorship and anti-body decay. A clinical trial assessed its safety (anaphylactic reactions or serum sickness) and simulated post-exposure prophylaxis (safety and anti-body profile).

Officials at the DOH and the University of the Philippines’ (UP) Microbial Immunology department are also seeing SPC’s technology as applicable in other pharmaceutical products such as the potential edible vaccine for salmonella, the typhoid fevercausing bacteria which is now being studied at UP Manila.

This is also useful for hepatitis B vaccine or influenza vaccine. The ARS, which basically comes from antibodies produced by horses, was accidentally developed as the family of Manayaga, a chemical engineer, has been into the local distribution of a protein purification system which is useful for the vaccine’s manufacturing.

The purification system, called chromatography, involves an equipment that can produce highly-purified proteins compared to the process of precipitation used traditionally in purification. Chromatography is also used in anti-cancer drugs, insulin, and recombinant genetically-engineered products.

This technology, developed in Sweden and produced by GE Healthcare Biosciences, also produces ARS at a faster rate which is five times more than traditional systems.