The facility in Bangalore, India will use process technology from Boehringer, which should simplify transfer and scale-up if clients want to use the Germany-based company’s European commercial production capacity.
Kemwell’s clients will have preferred access to Boehringer’s facilities and this, coupled to the efforts to simplify transfer, is intended to help clients reduce time to market.
Use of Boehringer’s BI HEX high expression system, which speeds the development of high-titer processes for producing biologics from Chinese hamster ovary (CHO) cells, is also expected to cut time to market for the contract manufacturing organisation’s (CMO) clients.
The 15,000 sq m Kemwell facility, which the company plans to invest $50m (€36m) in, is designed for process development, production, purification and formulation of biologics for early-phase preclinical and clinical studies.
A current good manufacturing practice (cGMP) compliant facility and sterile fill and finish site are planned. In addition the site will house process development laboratories to support production of protein therapeutics from microbial fermentation or mammalian-cell culture.
Microbial fermentation of up to 1000L will be installed as well as cell culture bioreactors up to 2000L. Flexible downstream processing capacity is also in the plans.
For clients needing process development Kemwell is installing separate microbial and cell culture laboratories that will scale up to 80L and provide research and preclinical material using similar equipment to the cGMP plant.
In addition the site will have aseptic filling and lyophilisation capacity. This will be capable of handling fill volumes ranging from 2ml to 20ml and have a capacity of 30,000 vials per batch.
Biologics in India
The new facility marks Kemwell’s first move into biologics, a sector that it believes is currently untapped in India.
For clients to transfer work to the country they will have to be reassured that it is capable of handling biologics, a process that Singapore put significant effort into, and Boehringer’s presence should help with this.