Bioneeds Laboratory Animals and Preclinical Services has invested $2 million for infrastructure expansion. This includes a canine (dog) unit. It is also in the process of completing its documentation for the Good Laboratory Practice (GLP) certification.
The company is registered with Committee for the Purpose of Control and Supervision of Experiments on Animals (CPCSEA) to breed and carry out experiments for which it also has a drug test license from the Drugs Controller General of India (DCGI) besides an import license from the Directorate General of Foreign Trade (DGFT) to source animals including the specific disease models. Its Institutional Animal Ethics Committee oversees the scientific and ethical issues of animal usage.
The two year-old company has been offering pre-clinical services for which tests are carried out on rats, guinea pigs and rabbits to Indian and a few companies in Australia. Now it intends to attract more contract pre-clinical research orders both from India and abroad.
Once GLP India certification is through, Bioneeds will look at audits from Germany, Netherlands and US to handle international customers from regulated regions.
The cost of conducting pre clinical studies is 30 per cent cheaper in India. In the wake of the economic slowdown, India and China are much-sought-after hubs to carry out clinical research because of the quality process, impressive infrastructure and scientific talent. Bioneeds is gearing up to arm itself to grab significant business from the global markets, Dr SN Vinay, Babu, head, Bioneeds told Pharmaquest.biz
The facility to house dogs to carry out tests will give a further fillip to its animal research efforts. Although there are many pharma companies which have animal house facility they are all for in-house testing.
In order to tap and build business, Bioneeds is on the look out for potential collaborators and venture capitalist as the way forward. We need to partner to tap new projects or undertake joint animal research efforts to scale up operations, stated Dr Babu.
While the pharma companies carry out the tests in-vitro, Bioneeds conducts the animal studies to ascertain the abnormal toxicity levels and bioassays to gauge the potency of the drug in-vivo. There has been a major demand for the test reports on studies carried out on dogs and this led us to set up a dedicated canine centre, said Dr Babu.
It is mandated that animal tests should include one rodent and non rodent species which could be a primate or dog or rabbit in India. In fact, this test is a critical phase in the pre-clinical research to understand the oral toxicity, dermatological and ophthalmologic irritation and sensitivity. Such tests are carried out for pharma, biotech, cosmetics, agro chemicals, water and industrial chemicals companies.
Further surgeries to retrieve the tissue samples of animals help to examine drug interactions. In addition transgenic animal models which have the appropriate disease gene like obesity, diabetes, arthritis, pain, gastric acidity helps to study the safety pharmaco-analysis on the central nervous system, autoimmune system, cardiology and respiratory systems.
While much of its revenues are generated from the pre clinical services model, it also offers a section of its infrastructure to pharma-biotech companies on rent to carry out their research. Such a concept is 50 per cent cheaper for the tenants instead of an in-house unit and is viable for high volumes research assignments, said Dr. Vinay.
For the future, Bioneeds is looking at becoming a total drug discovery solutions provider, through collaborative business model.