ANNUAL REPORT - Department of Biotechnology

Medical Biotechnology
Health related biotechnology research has assumed
a central place in the field of biotechnology. The
department during the year has made concerted
efforts to focus research activities in the area of
vaccines & diagnostics, infectious disease biology,
chronic disease biology, stem cell research and
bioengineering. A new impetus has been given to
newer diagnostic approaches, better therapeutics,
vaccines, diagnostics, clinical proteomics, cancer
biology, cardiothoracic, bioengineering, neurological
disorders, RNAi, medical devices etc. that are aimed
through generation of good infrastructure, trained
manpower and high-class science. An active
collaboration with the industrial partners is being
sought in all product oriented projects. A major
emphasis has been given towards development of
newer vaccines dengue, chicken guinea, typhoid,
HPV, and continued efforts were made to carry out
clinical trials of rotaviral diarrhoea vaccine, malaria,
typhoid, rabies etc. The various Task Forces of
medical biotechnology met thrice during the year
alongwith expert committees, inter-disciplinary
research committees and more than 100 new
projects have been recommended for support they
reviewed the progress of ongoing projects. Follow up
action has been initiated wherever leads are
available.
The significant progress are highlighted below :
Vaccines & Diagnostics
Cholera
The oral, live, recombinant, non-residual cholera
candidate vaccine strain VA1.3 developed through
DBT's financial support using novel methods of
strain isolation and genetic manipulations completed
Phase 1 safety trials and Phase IIa efficacy trials
after detailed pre-clinical animal toxicology studies.
The vaccine has been patented in USA and India and
all necessary regulatory approvals required for
recombinant products as per EPA, 1986 obtained.
Fermentation conditions as well as a semi-synthetic
medium, which allows healthy growth of vaccine
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strain without loss of physiological viability ensuring
genetic stability, have been worked out. A site for
Phase III human clinical trials has been prepared with
all necessary demographic patterns in a slum
population of about 50,000 in Kolkata.
During the year, proposals were invited from
competent industries for licensing and/or contract
manufacture of the clinical grade material under
cGMP for conducting Phase III human clinical trials
following ICH-GCP guidelines. Shantha Biotechnics,
Hyderabad has been identified through a competitive
bidding for the pre-filled and finished product on a
contractual basis. Clear-cut “Product Development
Plan” and “Clinical Development Plan” have been
laid. Management Structures to monitor formulation,
regulatory and clinical trial issues are being
established outside DBT for ensuring quality and
timelines.
Typhoid Vaccine Development Technology
Transferred to Industry
Work towards development of Vi-Conjugate typhoid
vaccine has been carried out at the All India Institute
of Medical Sciences (AIIMS), New Delhi. The
conjugate typhoid vaccine has been developed. The
vaccine has shown promising results in animal
studies. This vaccine may be effective even in
children below two years of age and school going
children. Therefore, it has the potential to prevent
typhoid fever more effectively than Vi alone in
children and adults, thereby the morbidity and
mortality could be reduced to a greater extent. The
technology has been transferred to M/s. USV Ltd.,
th
Mumbai on 19 July 2006 through a License
Agreement with Biotech Consortium India Ltd.
(BCIL), New Delhi to upscale, manufacture (cGMP
grade), preclinical toxicological studies and human
clinical trials.
Tuberculosis
As a sequel to a “Brain storming” held in May 2005,
the approach towards research on tuberculosis has
been broadened and funding expanded during the
year. The department invited proposals through open