Kemwell sets up biopharmaceuticals facility on Boehringer Ingelheim’s Bi Hex platform technology

Indian contract manufacturing services provider Kemwell is building a new biopharmaceutical manufacturing plant in Bangalore, with technical assistance from the Germany-based Boehringer Ingelheim.

As per the terms of a strategic alliance Kemwell will get access to Boehringer Ingelham’s Bi Hex technology platform for cell line development.

Kemwell’s new 15,000 sq.mt. greenfield state-of-the-art facility will be designed for process development, fermentation, purification and formulation of biologics for early-phase preclinical and clinical studies. 

The Kemwell Biologics factory will be located on the Kemwell site in Bangalore as it will share synergies with the other facilities on the site. 

The facility will consist of a cGMP drug substance manufacturing facility and a sterile fill and finish facility for drug product with a floor for process development laboratories to support production of protein therapeutics from mammalian-cell culture or microbial fermentation.

Kemwell will also have preferred access to the large-scale commercial production of Boehringer Ingelheim at its facilities in Europe.  

Kemwell expects the collaboration would help make the best of both worlds:the high-end European manufacturing technology and India’s low cost edge.

“Most importantly, Kemwell and Boehringer Ingelheim will provide the customer with state-of-the-art technology from Europe along with the benefit of low cost manufacturing from India”, stated Anurag Bagaria, vice-president of Kemwell in a media release.
 
Kemwell could see high opportunities for supplying monoclonal antibodies and that too in a timely and cost-effective manner, said Mr Bagaria.
Kemwell will also provide in-house experts in toxicology and clinical development and partner with Indian CROs to help customers manage toxicology and clinical studies in India.

Kemwell will complement its early clinical supply services ranging from full-service process development, manufacture, formulation and fill & finish at the cGMP manufacturing facility in Bangalore, India as a one-stop-shop through this collaboration.
 
Kemwell has facilities dedicated for tablets, semi-solids and liquids manufacturing as well as pharmaceutical development services on the same site and can thus synergize its current competencies by using existing trained personnel in analytical and quality services at the new facility.  
 
Boehringer Ingelheim hoped to strengthen its presence for biologic services in Asia, providing state of the art technologies for economic manufacturing of innovative, high quality biopharmaceuticals, through the partnership with Kemwell Biologics, commented Prof. Dr. Dr. h.c. Rolf G. Werner, corporate senior vice president of the Corporate Division Biopharmaceuticals, Boehringer Ingelheim GmbH.
 
Bangalore-based Kemwell Pvt. Ltd. is a leading provider of formulations contract manufacturing and development services for multinational pharmaceutical companies for over 20 years.  From facilities in India and Sweden, Kemwell manufactures tablets, capsules, liquid orals, external drops, ointments, gels and creams. Kemwell’s customers include 5 of the top 10 pharmaceutical companies in the world, manufacturing 5 of the top 10 brands in India.  Kemwell’s Pharmaceutical Development Unit provides services in clinical manufacturing and packaging, formulation and analytical development, stability studies, regulatory documentation etc. Kemwell has no branded products of its own in the market.  
 
Headquartered in Ingelheim, Germany, Boehringer Ingelheim group is one of the world’s 20 leading pharmaceutical companies. It operates globally with 138 affiliates in 47 countries and 41,300 employees. Boehringer Ingelheim is into researching, developing, manufacturing and marketing novel products of high therapeutic value for human and veterinary medicine.
 
Boehringer Ingelheim is one of the leading companies for industrial customer manufacturing of biopharmaceuticals by offering the entire production technology chain in development and production at its biopharmaceutical facilities in Biberach (Germany) and in Vienna (Austria). 

Boehringer Ingelheim’s large scale manufacturing sites deliver biopharmaceutical products like therapeutic proteins, fusion proteins, protein scaffolds, monoclonal antibodies, antibody fragments and plasmid DNA.
The Biberach site is specialized in highly efficient mammalian cell culture systems with yields well above industry standard in animal component free media.

The Austria site offers high-expression in bacteria and yeast with exceptionally high productivities using proprietary systems. In the plasmid DNA manufacturing arena Boehringer Ingelheim in Austria has set the standard and supplies early to late-stage clinical trials with gene-therapeutics and DNA vaccines for its international clients.