The biomanufacturing facility in Bangalore, India, was constructed with collaboration from Boehringer Ingelheim and intended to marry European technology with Indian low cost manufacturing benefits in order to attract Western companies.
Following its recent completion, Kemwell Biopharma has completed a deal to manufacturing mAbs for a European “mid-size biopharma company,” Chairman Anurag Bagaria told Biopharma-Reporter.com though could not reveal who due to client confidentiality.
“Our biomanufacturing facility has just commenced operations and this is the first contract,” he told us. “We are targeting more customers from the West based on our established track record on the pharmaceutical development and manufacturing services, quality and cost.”
The deal will see Kemwell provide a fully integrated solution for developing and manufacturing mAb therapeutics, including technology transfer, process industrialization, scale-up, manufacturing of toxicology materials, cGMP manufacturing of clinical materials and commercial manufacturing.
Opening Up India to Biomanufacturing
Over the last decade, pharma companies from North America and Europe have been using Indian contract manufacturing organisations (CMOs) to supply small molecule drugs, generic and active pharmaceutical ingredient (API) thanks to the low costs associated with the region.
However, India is yet to have become an area for contract biomanufacturing partially due to quality concerns, bio-logistic costs and communication problems.
Yet one reason for minimal uptake of Indian contract biomanufacturing, Bagaria added, is the lack of options for Western biopharmas.
He said: “I am aware of only one other biomanufacturing service provider, Syngene. However, Syngene’s scale of manufacturing is only up to 300L whereas our scale goes up to 2000L. There is no other service provider in India as far as I know.”
The opening of Kemwell’s 15,000m2 cGMP plant, therefore, may help to change that, he said, as this will help increase Indian biomanufacturing services for Western firms, as evident with the mAb contract.
“On the pharmaceuticals side 99% of our business from our Indian facilities is with Western companies,” he told us. “We hope to create a similar customer base for the biologics business.”
This will be aided by an inspection from a European agency at the facility expected by the firm later on this year.
Biopharma-Reporter.com contacted Syngene - a subsidiary of Biocon - by telephone and email to clarify it was the only other biomanufacturing service provider in India but did not receive a response at the time of going to press.