East Meets West in Contract Biologics Manufacturing

A joint biopharmaceutical manufacturing facility in India by Kemwell and Boehringer Ingelheim ushers in a new era.
Aug 06, 2009

The contract manufacturing organization (CMO) Kemwell (Bangalore, Karnataka, India) and Boehringer Ingelheim (BI, Ingelheim, Germany) plan to jointly build a biopharmaceutical manufacturing plant in Bangalore, India. The joint facility provides BI with low-cost production in Asia for its contract biologics manufacturing business and adds contract biologics manufacturing to Kemwell's toolbox.

A biologics marriage

The 15,000-m2 facility will be designed for process development, fermentation, purification, and formulation of biologics for early-phase preclinical and clinical studies. The facility will have drug-substance manufacturing under current good manufacturing practices, sterile fill–finish, and process development to support production of therapeutic proteins from mammalian-cell culture or microbial fermentation. Kemwell will provide in-house expertise in toxicology and clinical development and partner with Indian contract research organizations (CROs) to manage toxicology and clinical studies in India.

Building the toolbox

Kemwell's contract-service capabilities are largely centered on formulation development and secondary manufacturing. Its Bangalore site manufactures tablets, semisolids, and liquids and provides pharmaceutical development services. It also performs contract manufacturing of small-molecule active pharmaceutical ingredients (APIs) at its facility in Uppsala, Sweden. The Uppsala facility also produces and packages tablets and suppositories and has annual capacity of one billion tablets. Kemwell acquired the Uppsala facility from Pfizer (New York) in 2006.

Kemwell's pact with BI is its third alliance with a Western CMO or Big Pharma company during the past 12 months. In November 2008, Kemwell set up a research and development (R&D) facility in Bangalore in partnership with GlaxoSmithKline (London) for developing oral healthcare products. In April 2009, Kemwell formed a strategic pact with the CMO Patheon (Toronto) for client referral and marketing services. The latter deal provides Kemwell with aseptic and high-potency manufacturing and gives Patheon low-cost manufacturing for solids, semisolids, and liquids and related development services in India.

The Kemwell–BI facility provides BI a low-cost manufacturing base in Asia. BI produces biologics captively for its own products and its contract-manufacturing business. BI's contract business produces biological drug substances, finished-drug products, and pharmaceutical chemicals. Under the pact, BI is contributing access to its BI-HEX cell-line development process, large-scale commercial production at its European facilities, and client referrals.

BI's European biopharmaceutical facilities are in Biberach, Germany, and Vienna, Austria. The Biberach facility focuses on mammalian-cell-culture technologies, which include the BI-HEX expression system, for producing high-volume protein therapeutics, primarily monoclonal antibodies. BI's Vienna facility uses microbial and yeast-based fermentation to produce therapeutic proteins, protein subunit vaccines, protein scaffolds, antibody fragments, and plasmid DNA for gene therapy, according to BI's 2008 annual report.