India has a well-established small molecule generics and active pharmaceutical ingredients (APIs) industry but the recent approval of Biocon and Mylan’s biosimilar of Roche’s Herceptin, and the opening of Kemwell’s biologics plant shows evidence of a slow shift towards biomanufacturing.
In order to help bridge the gap between the needs of the industry and the shortfalls in local talent, Biocon has teamed up with the California, US-based Keck Graduate Institute (KGI) to form the Biocon Academy, devoted solely to bioscience education and discovery.
According to the firm’s Managing Director Kiran Mazumdar-Shaw, the academy “aims to bring world class training programs for biotech students in India through customized programs like the Biocon KGI Certificate program in Biosciences and make them employable.”
The application process closed last week, but the 16 week full-time course will commence in January and is aimed at making biotech graduates employable through advanced learning and industrial training.
The programme itself will consist of nine modules across all aspects of biopharmaceuticals, including studies on QA/QC, CMC regulations, fermentation, mammalian cell biotechnology, bioseperation and an introduction to US and European regulations.
“Biocon will offer a merit scholarship of 75% of the course fee for all the meritorious students selected through an intensive selection process,” Mazumdar-Shaw added, and on completion the firm said there will be job opportunities at both Biocon and other biotech firms.
India’s Contract Biomanufacturing Industry
When Kemwell announced its first contract to manke monoclonal antibodies with a Western biopharma firm back in September, Chairman Anurag Bagaria told this publication he was aware of only Biocon (through its subsidiary Syngene) offering contract biomanufacturing from india.
“On the pharmaceuticals side 99% of our business from our Indian facilities is with Western companies,” he said, adding that the firm hoped to replicate this in its new biologics business.
However, other than India suffering from an undertrained workforce, questions about quality in the country may be putting some Western firms off, according to delegates from a contract manufacturing conference in London, earlier this year.
Recently, Indian manufacturer Wockhardt was struck with a second import alert this year by the US Food and Drug Administration, whilst Ranbaxy too has had its fair share of quality problems.