East Meets West in Contract Biologics Manufacturing - Pharmaceutical Technology

Latest Issue
PharmTech

Latest Issue
PharmTech Europe

East Meets West in Contract Biologics Manufacturing
A joint biopharmaceutical manufacturing facility in India by Kemwell and Boehringer Ingelheim ushers in a new era.


PTSM: Pharmaceutical Technology Sourcing and Management
Volume 5, Issue 8

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.


ADVERTISEMENT

blog comments powered by Disqus
LCGC E-mail Newsletters

Subscribe: Click to learn more about the newsletter
| Weekly
| Monthly
|Monthly
| Weekly

Survey
What role should the US government play in the current Ebola outbreak?
Finance development of drugs to treat/prevent disease.
Oversee medical treatment of patients in the US.
Provide treatment for patients globally.
All of the above.
No government involvement in patient treatment or drug development.
Finance development of drugs to treat/prevent disease.
27%
Oversee medical treatment of patients in the US.
14%
Provide treatment for patients globally.
8%
All of the above.
41%
No government involvement in patient treatment or drug development.
11%
Jim Miller Outsourcing Outlook Jim MillerCMO Industry Thins Out
Cynthia Challener, PhD Ingredients Insider Cynthia ChallenerFluorination Remains Key Challenge in API Synthesis
Marilyn E. Morris Guest EditorialMarilyn E. MorrisBolstering Graduate Education and Research Programs
Jill Wechsler Regulatory Watch Jill Wechsler Biopharma Manufacturers Respond to Ebola Crisis
Sean Milmo European Regulatory WatchSean MilmoHarmonizing Marketing Approval of Generic Drugs in Europe
FDA Reorganization to Promote Drug Quality
FDA Readies Quality Metrics Measures
New FDA Team to Spur Modern Drug Manufacturing
From Generics to Supergenerics
CMOs and the Track-and-Trace Race: Are You Engaged Yet?
Source: PTSM: Pharmaceutical Technology Sourcing and Management,
Click here