Bioneeds Preclinical Services has invested Rs.9
crore ($2 million) to commission a new Good Laboratory Practice (GLP)
unit for rabbit studies and dog studies.

The newly commissioned
facility has its infrastructure and processes in compliant with the OECD
(Organization for Economic Co-operation and Development) accredited
laboratories which are the key principles of Good Laboratory Practice,
Dr SN Vinay Babu, head, Bioneeds told Pharmabiz.

Commissioning of
new facility has increased the capacity of breeding and experimentation
of rodents and non rodents. Now we have dedicated animal rooms for GLP
toxicity studies, efficacy studies, drug testing studies, rabbit studies
and dog studies, he added.

The lab is built as per national
& international guidelines and spans over an area of 35,000 sq ft.
There are 8 block of animal rooms, 56 exclusive animal rooms, besides
dedicated rooms for breeding & experimentation. There is also a
clean corridor, return service/dirty corridor, quarantine, autoclave,
feed store, necropsy room, procedure rooms, surgery room and laboratory
areas. Each block has independent AHU with HEPA filters. Current
personnel strength of the company is 65 and hiring will romp up the
employee numbers to 100 by end of 2011.

The assignments that
will be carried out here are GLP toxicity studies, non rodent studies,
rodent and non rodent efficacy studies, dog pharmacokinetic studies,
polyclonal antibody production, contract breeding of rats, mice and
rabbits and lending of animal rooms on rental basis.

The 20 dog
facility is ready and will be operational by January 2011 as we are
waiting to get approval to import dogs from Directorate General of
Foreign Trade (DGFT). Many pharma and biotech companies are availing our
services. One of the unique trend in the recent times is association
with many clinical trial companies to provide necessary regulatory data
to support the studies. We could also serve many international companies
for their regulatory and non regulatory requirements. Many
international companies who would like to establish CRO business in
India are looking to associate with us, said Dr Vinay Babu.

Even
though CRAMS business is rapidly growing in India, preclinical testing
is not yet fully tapped. We could see lot of opportunity for preclinical
testing. There are less than 10 GLP certified CROs in India. All other
CROs are focusing either only on toxicity studies or complete drug
discovery services but Bioneeds is gearing up to be a one stop solution
of all animal studies with all animals. The lab will be GLP tox, Non GLP
tox, efficacy, safety, immunizaiton or biomatrix for diagnostic
purpose.

GLP certification, wide range of services, flexible
timelines , quality and cost effective services of Bioneeds should put
the company in a top slot, he said.

While there is a huge
opportunity to be tapped in pre-clinical services, there is the huge
challenge of lack of availability of trained staff, Quality animals,
availability of non rodents, diagnostic tools for rodent and non rodents
and transgenic disease models, stated Dr Vinay Babu.