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Kemwell to build Biopharmaceutical Manufacturing Facility in India in Collaboration with Boehringer Ingelheim, Germany
Kemwell to build Biopharmaceutical Manufacturing Facility in India in Collaboration with Boehringer Ingelheim, Germany
Kemwell completed the groundbreaking ceremony of a new biopharmaceutical manufacturing plant in Bangalore, India, in a strategic collaboration with Boehringer Ingelheim, Germany.
With this collaboration, Kemwell will complement their 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 access to Boehringer Ingelheim’s cell line development with the BI HEX® technology platform, followed by a preferred access to the large-scale commercial production of Boehringer Ingelheim at its facilities in Europe. “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”, says Anurag Bagaria, Vice-President of Kemwell.
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 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.
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. 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.
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. Thus, the customer can benefit from low costs through the development process.
“Kemwell will continue its commitment to pure-play contract manufacturing and build on its extensive experience in contract manufacturing. We find high opportunities for supplying monoclonal antibodies and are committed to provide these services in a timely and cost-effective manner”, says Anurag Bagaria, Vice-President of Kemwell.
”Through the partnership with Kemwell Biologics, Boehringer Ingelheim will strengthen its presence for biologic services in Asia, providing state of the art technologies for economic manufacturing of innovative, high quality biopharmaceuticals,” comments Prof. Dr. Dr. h.c. Rolf G. Werner, Corporate Senior Vice President of the Corporate Division
Biopharmaceuticals, Boehringer Ingelheim GmbH, who was present at the groundbreaking ceremony in Bangalore.
India is fast developing into a low-cost manufacturing partner for biopharmaceutical companies. The vast pool of scientific talent, a world-class information technology industry, and a vibrant domestic market are positioning India to emerge as a significant spot on the global biotech map. India is also home to the largest number of English speaking scientists outside the U.S. The growth has been tremendous and today India has the largest number of USFDA facilities outside of the U.S.
Bangalore, the capital of Karnataka in south India, is touted as India’s biotechnology capital. It boasts Biocon India Ltd., the first and largest biotech player in India, Astra Zeneca’s Research Headquarters, the Indian Institute of Science, the National Center of Biological Sciences, scores of startups oriented to informatics and genomics, and a number of venture companies looking to diversify from IT to the life sciences.
About Kemwell Pvt Ltd (www.kemwellpharma.com):
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. With a 100% commitment to pure play contract manufacturing, Kemwell has no branded products of its own in the market, thereby avoiding any conflict of interests with its customers.
About Boehringer Ingelheim (www.boehringer-ingelheim.com):
The Boehringer Ingelheim group is one of the world’s 20 leading pharmaceutical companies. Headquartered in Ingelheim, Germany, it operates globally with 138 affiliates in 47 countries and 41,300 employees. Since it was founded in 1885, the independent, family-owned company has been committed to 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).
The 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.
Ämnen
- Medicin, läkemedel
Kategorier
- kemwell
- biopharmaceutical manufacturing plant
- bangalore
- germany
Kemwell AB är en del av Kemwell Group och det familjeägda Kemwell Pvt Ltd i Indien med huvudkontor i Bangalore. Kemwell Group är en ledande tillverkare inom kontraktstillverkning av läkemedel för global distribution. Företaget tillverkar läkemedel till fem av världens tio största läkemedelsföretag, exempelvis GlaxoSmithKline, Johnson & Johnson och Pfizer. Kemwell Pvt Ltd är en av Indiens största kontraktstillverkare av läkemedel med över 25 års erfarenhet. Koncernen har mer än 1000 anställda och sju produktionsanläggningar år 2011, fem anläggningar i Indien och en i Sverige. Kemwell Group är godkänd läkemedelstillverkare för den amerikanska, europeiska, japanska och indiska marknaden. Läs mer om Kemwell på www.kemwellpharma.com
Kemwell AB is a part of the Kemwell Group and the family owned Kemwell Pvt Ltd of India with its’ head office in Bangalore. Kemwell Group is a leading contract manufacturer of pharmaceuticals for global distribution. The company produces pharmaceuticals for five of the ten largest pharmaceutical companies in the world such as GlaxoSmithKline, Johnson & Johnson and Pfizer. Kemwell Pvt Ltd is already one of the largest contract manufacturers of pharmaceuticals in India with more than 25 years experience. The company has more than 1,000 employees worldwide and will by 2011 have seven production units - five in India and one in Sweden. Kemwell is licensed to develop pharmaceuticals for the American, European, Japanese and Indian markets. For more information about Kemwell: www.kemwellpharma.com