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Provider profile

Aragen.

Biologics CDMOs

Aragen, a CRDMO that also serves small-molecule programmes, describes biologics cell line development (CHO) in Morgan Hill, California and upstream, downstream and analytical development and cGMP clinical drug substance manufacturing of monoclonal antibodies in single-use bioreactors at Jigani, Bengaluru, India. Biologics drug product manufacturing is not documented. Its global headquarters is in Hyderabad, India.

Website
aragen.com (opens in a new tab)
Sources reviewed
November 4, 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
  • Cell line development1,2Cell line development performed in Morgan Hill, California (Aragen Bioscience campus)
  • Formulation development4Listed as formulation screening within biologics process research and development
  • GMP drug substance manufacturing3Clinical drug substance; GMP capacity of 2.50 KL in Jigani, Bengaluru, commissioned in the third quarter of fiscal 2026
  • Process development3
  • Stability studies4Listed within biologics process research and development
  • Technology transfer5Stated for biosimilars

Platforms and methods

  • Mammalian cell culture5
  • Single-use bioreactors3

Drug substance / drug product

  • Drug substance3cGMP drug substance manufacturing stated for clinical supply (single-use bioreactors)

Development experience

Development experience

Modality

  • Monoclonal antibodies5mAb process development and manufacturing stated for the Bengaluru facility

Locations

Locations

  • Hyderabad, India · Headquarters2Global headquarters (Nacharam); the Hyderabad sites are listed for small-molecule R&D and manufacturing
  • Bengaluru, India · Manufacturing site2Biologics process development and GMP drug substance manufacturing (Jigani); single-use, 2.50 KL installed capacity
  • Morgan Hill, United States · Laboratory2Operated as Aragen Bioscience: biologics R&D, cell line development and non-GMP small-scale manufacturing

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.

  • GMP / cGMP3Stated for biologics clinical drug substance manufacturing

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

Not established from reviewed sources: development stage.

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Evidence and sources

Evidence and sources

  1. 1Biologics GMP Manufacturing | Single-Use Bioreactors | Aragen (opens in a new tab)Aragen · Provider website · retrieved November 3, 2026 · last checked November 3, 2026
  2. 2CRDMO Services | Contract R&D Manufacturing Solutions - Aragen Life Sciences (opens in a new tab)Aragen · Provider website · retrieved November 3, 2026 · last checked November 3, 2026
  3. 3Large Molecule Biologics & Manufacturing Solutions - Aragen Life Sciences (opens in a new tab)Aragen · Provider website · retrieved November 3, 2026 · last checked November 3, 2026
  4. 4Large Molecule Drug Development Research - Aragen Life Sciences (opens in a new tab)Aragen · Provider website · retrieved November 3, 2026 · last checked November 3, 2026
  5. 5Cell Line Development Services - Aragen Life Sciences (opens in a new tab)Aragen · 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

Contact the provider directly through its public contact page (opens in a new tab). ArgusBio does not forward inquiries to providers and does not receive referral fees.

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