Kemwell has added commercial-scale lyophilisation capacity at its plant in Bangalore, India citing growing demand from the sterile injectables sector.
The technology has capacity for 4,000 50ml vials or 29,000 2ml vials, cleaning in place (CIP) and sterilization in place (SIP) capabilities and means the contract manufacturing organisation (CMO) can provide freeze-drying from preclinical research through to commercial scale.
Managing director Anurag Bagaria said: “The outsourcing of services in bio/pharmaceutical industry is growing and Kemwell will continue to invest into technologies to support our customers’ needs.”
Kemwell set up the facility in Bangalore, India in 2008 with help from German privately-owned drugmaker Boehringer Ingelheim, which assisted with "technical design of the plant" according to spokeswoman Karan Bagaria who told Outsourcing-pharma.com about the expansion.
This site already features a BI HEX high expression system, which is designed to accelerate the development of high-titer processes for producing biologics from Chinese hamster ovary (CHO) cells.
Last year Kemwell signed its first biomanufacturing contract for the plant when it was hired by an unnamed mid-size European biopharma company.
At the time Bagaria told Outsourcing-pharma.com that: “On the pharmaceuticals side 99% of our business from our Indian facilities is with Western companies, We hope to create a similar customer base for the biologics business.”
Under that deal Kemwell agreed to provide tech transfer, process industrialization, scale-up, manufacturing of toxicology materials, cGMP manufacturing of clinical materials and commercial manufacturing for both drug substance and fill & finish in vials for the client.
The addition of freeze-drying technology has further expanded its fill finish offering.