Utilizing the funding from BIPP, Tergene
Biotech initiated a project to develop an indigenous vaccine to tackle
pneumonia that kills more children under the age of five than any other
Pneumonia kills an estimated 1.6 million children under the age of five
globally, every year, according to statistics available with the World
Health Organization. The number is more than the combined deaths due to
AIDS, malaria and tuberculosis in this age group. The report card
released by the International Vaccine Access Center says, in India,
pneumonia claims lives of more than 3.7 lakh children every year.
The above facts together with the realities that indigenously
manufactured vaccines for the disease are non-existent in the country
and the high cost of imported vaccines necessitate the development of
affordable indigenous technology and manufacturing capabilities. Keeping
this in mind, Hyderabad-based company Tergene Biotech launched a project
to develop a 15-valent pneumococcal polysaccharide conjugate vaccine
with CRM 197 as the carrier protein. The objective is to make it
India-specific and affordable to the common man.
The company, a third generation technology development company in the
field of vaccines and therapeutic proteins, received a grant of `15 lakh
from the Department of Biotechnology (DBT) to demonstrate
proof-of-concept at lab-scale under the Biotechnology Industry
Partnership Programme (BIPP) scheme. The company received the grant
after the DBT called for affordable healthcare technologies with
specific reference to pneumococcal conjugate vaccine in November 2010.
Explaining the technology, Dr M Kuppusamy, managing director of Tergene
Biotech, says, “The 15 serotypes used in our vaccine account for 80
percent of the total serotype prevalence in India. The company has
developed its own in-house technology to manufacture the carrier
protein. CRM 197, the safest and highly immunogenic carrier protein of
choice, together with the flow chemistry-based conjugation constitutes
the platform technology for all its polysaccharide-based conjugate
Tergene also had the options to develop a Haemophilius influenzae B
conjugate vaccine and acellular pertussis vaccine directed to prevent
the main causative bacterial agents of pneumonia, but is presently
focused on the pneumococcal polysaccharide conjugate vaccine.
“We are thankful to the DBT for the timely initiative. A public private
partnership is a real opportunity for start-ups promoted by scientists
with technology as the prime investment,” says Dr Kuppusamy.
The way forward
The company is setting up a manufacturing facility (as per Good
Manufacturing Practices norms) near Chennai, Tamil Nadu. The
state-of-the-art facility will be operational by mid 2013 and will be
used to manufacture vaccines, biopharmaceuticals and probiotics. This
will give Tergene a manufacturing facility matching the specifications
of the US Food and Drug Administration.
The company is hopeful of receiving further support from the DBT to
complete the cGMP clinical lot manufacturing, clinical trials and
eventually commercial manufacturing. “According to estimates, we would
be in a position to launch the vaccine in 24 months,” says Dr Kuppuswamy.
He said they were confident of pricing the vaccine at one-third the cost
of the imported vaccine, which is available at an MRP of Rs 3,800 per
dose. “As per recommendations, infants require four doses of the
vaccine,” he adds.
Rahul Koul in NewDelhi