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Provider profile

Kemwell Biopharma.

Biologics CDMOs

Kemwell Biopharma describes cell line, process, analytical and formulation development and cGMP drug substance and drug product manufacturing (liquid and lyophilized vials, prefilled syringes) for mammalian cell culture proteins, including monoclonal antibodies, fusion proteins and bispecifics, with Phase III and commercial supply. It lists its headquarters and facilities in Bengaluru, India.

Website
kemwellbiopharma.com (opens in a new tab)
Sources reviewed
November 3, 2026 · Source pages re-checked within 4 months
First published
November 3, 2026

This profile summarizes what public sources state about the provider, mostly its own website. It is not an audit, qualification or endorsement by ArgusBio. Confirm capabilities directly with the provider before contracting.

Services and capabilities

Services and capabilities

  • Analytical development and QC testing1,2
  • Cell line development3
  • Formulation development3,4
  • GMP drug product manufacturing1,6
  • GMP drug substance manufacturing1,5
  • Lyophilization1,3Lyophilized vial filling and lyophilization cycle development
  • Process development1,2
  • Stability studies3,4
  • Technology transfer2,3

Platforms and methods

  • Mammalian cell culture2,7
  • Single-use bioreactors1,7

Drug substance / drug product

  • Drug product1,6
  • Drug substance1,5

Development experience

Development experience

Development stage

  • Commercial1,3
  • Phase 35,8Stated as Phase III batch manufacturing for US IND trials
  • Preclinical3Stated as generation of toxicology study material within process development

Modality

  • Monoclonal antibodies1,7
  • Recombinant proteins1,5

Locations

Locations

  • Bengaluru, India · Headquarters1
  • Bengaluru, India · Manufacturing site9Listed as Bangalore; drug substance (stainless steel 80–2,000 L and single-use 200/1,000 L bioreactors) and drug product (liquid and lyophilized vials, prefilled syringes) at the same site

Quality and regulatory

Quality and regulatory

The provider’s own materials state that it works to, or holds, the following. ArgusBio has not inspected or audited these claims.

  • 21 CFR Part 117Stated for the central data management system in drug substance manufacturing
  • GMP / cGMP1,3

Unknowns and questions to ask

Unknowns and questions to ask

Public sources rarely establish what matters most for a specific project. Confirm directly:

  • Available capacity, slot timing and scale for your next campaign
  • Recent experience with your specific modality and expression system or chemistry
  • Regulatory inspection history of the specific site that would manufacture your product
  • Technology-transfer approach, timeline and who owns the resulting process knowledge
  • Analytical and QC release testing done in-house versus subcontracted
  • Quality agreement terms, batch-failure responsibility and change-order mechanics

Choosing a CDMO: a practical guide

Evidence and sources

Evidence and sources

  1. 1Kemwell Biopharma Facility in Bengaluru Successfully Completes U.S. FDA Inspection for Commercial Drug-Product Manufacturing - Kemwell Pharma (opens in a new tab)Kemwell Biopharma · Provider website · retrieved November 3, 2026 · last checked November 3, 2026
  2. 2Biologics Process Development Services | Kemwell (opens in a new tab)Kemwell Biopharma · Provider website · retrieved November 3, 2026 · last checked November 3, 2026
  3. 3USFDA Biologics Manufacturing Company | Kemwell Biopharma (opens in a new tab)Kemwell Biopharma · Provider website · retrieved November 3, 2026 · last checked November 3, 2026
  4. 4Drug Product Formulation Development | Contract Formulation Development (opens in a new tab)Kemwell Biopharma · Provider website · retrieved November 3, 2026 · last checked November 3, 2026
  5. 5Biologics cGMP Manufacturing | Kemwell (opens in a new tab)Kemwell Biopharma · Provider website · retrieved November 3, 2026 · last checked November 3, 2026
  6. 6Drug Product Manufacturing Services | Kemwell (opens in a new tab)Kemwell Biopharma · Provider website · retrieved November 3, 2026 · last checked November 3, 2026
  7. 7Drug Substance Process Development & Manufacturing | GMP Clinical Manufacturing (opens in a new tab)Kemwell Biopharma · Provider website · retrieved November 3, 2026 · last checked November 3, 2026
  8. 8Biologics CDMO | Biologics Contract Manufacturing Organization | Kemwell (opens in a new tab)Kemwell Biopharma · Provider website · retrieved November 3, 2026 · last checked November 3, 2026
  9. 9Kemwell Biopharma page: kemwellbiopharma.com/about (opens in a new tab)Kemwell Biopharma · Provider website · retrieved November 3, 2026 · last checked November 3, 2026

“Last checked” means we confirmed the page was still available and still contained the cited statement. It does not mean ArgusBio verified the provider or its capabilities.

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Contact

Contact

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