CPL Biologicals readies facility to produce 60 million vaccine doses

CPL Biologicals (CPLB), a joint venture of Ahmedabad based Cadila Pharmaceuticals Ltd and US based Novavax Inc has completed construction of its vaccine facility at Dholka near Ahmedabad that can produce up to 60 million doses of vaccines every year. The company said this in an announcement to Nasdaq.

A spokesperson of Cadila Pharma confirmed the development, but refused to divulge more details. The JV plans to produce seasonal and pandemic flu vaccines based on Novavax's advanced virus-like particle (VLP) technology which enables the rapid development and production of novel vaccines without the use of live virus.

Cadila's chairman I A Modi said in an e-mailed response, “The facility is undergoing the validation process. We will be able to start production on getting permission from FDA, Gujarat and DCGI.Vaccine against flu will be the first product to be launched. The VLP technology will enable us to respond fast in providing vaccine for emergency situations like pandemics. We will be the first company to launch a vaccine against flu employing recombinant VLP technology.”

After reporting 'favourable' results for H1N1 vaccine testing in Mexico, US-based $350 million biotech firm Novavax is hopeful of producing a similar feat in India, where it has a joint venture with Cadila Pharmaceuticals called CPL Biologicals. "We already have results from stage A trials that shows that the product is well tolerated and is producing the desired immunity levels. We are ready to roll out the product and our facilities in the US. We started registration trials in Mexico in October 2009 on 1000 people in stage A and another 3000 in stage B. The results of the stage A trials have already come on December 2, 2009", Rahul Singhvi, president and CEO of Novavax had indicated to Business Standard earlier. He had also added that the Dholka facility would come up with an investment of around Rs100 crore.

CPL Biologicals, however, did not get the requisite permission from the Drug Controller General of India to conduct clinical trials in the country for the Swine flu vaccine based on VLP technology.Meanwhile, another Ahmedabad based company Zydus Cadila rolled out the first indigenous swine flu vaccine based on egg-based technology recently.

Besides the Dholka facility, Novavax also has a facility in Rockville near Washington DC that has a capacity to roll out 30 million doses and has tied up with Xcellerex for contract manufacturing for Mexico.