Contract Manufacturing with Eastern Advantages and Western Standards

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Kemwell Biopharma is a single-source service provider supporting early product development to commercial supplies of biopharmaceutical products.

Founded in 1980, Kemwell is a 100% customer-oriented company with expertise in contract development and manufacturing services for pharmaceutical and biopharmaceutical products. Throughout its journey, Kemwell has maintained its pure-play status as a 100% contract services provider. Their core values and work culture being: “Customer Comes First. Always.” Kemwell has been successfully serving Big Pharma customers, including AstraZeneca, Bayer, GSK, Merck, Novartis, Pfizer, and many small and mid-pharma companies from its FDA and EMA certified facilities in India and Sweden.

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Kemwell now extends its reach to allow the biotechnology industry to take better advantage of the eastern promise of cost savings combined with the support and technology of the west. To offer these services, Kemwell has built a new 135,000- ft2 biopharmaceutical development and manufacturing facility in Bangalore, India. It was designed in collaboration with Boehringer Ingelheim under a strategic alliance. This facility offers services ranging from full-service process development, manufacture, formulation and fill and finish.

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Development Services

  • Process development

  • Formulation development

  • Analytical development and validation

  • Pre-clinical manufacturing

GMP Manufacturing Services

  • Drug substance (80-L, 400-L, and 2 × 2,000-L stainless steel)

    • Clinical and commercial manufacturing

  • Drug product

    • Vials

    • Lyophilization

    • Pre-filled syringes

  • Support services

    • Analytical and stability testing

    • cGMP cell banking and storage

    • Regulatory submission support

Why Kemwell?

Since this expansion into the biologics space builds on the sterling service Kemwell already provides to the pharmaceutical sector, the company can draw on its over 30-year experience of customer service and knowledge of global compliance requirements, including FDA and EMA requirements. The company boasts a deep understanding of customers’ requirements and prides itself on excellent quality service. These same values will be extended into the biotech services assuring affordable prices.

About the Author

Author Details
Christian Ahlmark (1-919-397-3000, [email protected]) and Bhaskar Viswanathan (91-96864-46433, [email protected]) are in business development at Kemwell Biopharma Pvt. Ltd., India, USA, and Sweden; www.kemwellbiopharma.com.

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