Provider profile

KBI Biopharma.

Biologics CDMOs · Part of JSR Life Sciences12

KBI Biopharma documents cell line development, process, analytical and formulation development, and cGMP drug substance manufacturing for biologics from first-in-human to commercial supply. It lists mammalian (CHO, single-use) manufacturing in Durham, NC, microbial (E. coli) manufacturing in Boulder, CO, and laboratories in Louisville, CO and Geneva, Switzerland. It names JSR Life Sciences as its parent company.

Website: kbibiopharma.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

Analytical development and QC testing3,4
Cell line development2
Formulation development7
GMP drug substance manufacturing5,6
Lyophilization7Stated as lyophilization cycle development; KBI states lyophilized formulations are transferred to fill/finish CMOs
Process development1,2Microbial process development stated for the Colorado (Boulder) site
Stability studies7,9
Technology transfer8

Platforms and methods

Mammalian cell culture5,10
Microbial fermentation2,11Stated for the Boulder, CO facility
Single-use bioreactors5,6

Drug substance / drug product

Drug substance5,6

Development experience

Development stage

Commercial1,2,5
Phase 12,6
Preclinical11Stated for microbial programs; development and preclinical activities are executed as non-GMP studies

Modality

Monoclonal antibodies1,4
Peptides7Stated for formulation development programs only; peptide manufacturing not established
Recombinant proteins8,11
Vaccines1,10Stated as expression and site project experience (SUREtechnology platform; Colorado site)

Locations

Durham, United States · Headquarters13Listed as Corporate HQ (Venture Center Facility, RTP/Durham, NC), with process and analytical development
Geneva, Switzerland · Laboratory13Listed for cell line development and manufacturability assessment
Boulder, United States · Manufacturing site13Microbial cell line development, process development and cGMP manufacturing
Durham, United States · Manufacturing site13Mammalian clinical and commercial cGMP manufacturing (Hamlin Road and Patriot Park facilities)
Louisville, United States · Laboratory13Analytical and biophysical characterization laboratory (Colorado)

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 / cGMP1,2,5

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

1Microbial Commercial Manufacturing - KBI Biopharma (opens in a new tab)KBI Biopharma · Provider website · retrieved November 3, 2026 · last checked November 3, 2026
2Cell Line Development Services - KBI Biopharma (opens in a new tab)KBI Biopharma · Provider website · retrieved November 3, 2026 · last checked November 3, 2026
3Biopharmaceutical Process Development and Manufacturing - KBI Biopharma (opens in a new tab)KBI Biopharma · Provider website · retrieved November 3, 2026 · last checked November 3, 2026
4Purification Process Analytical Development - KBI Biopharma (opens in a new tab)KBI Biopharma · Provider website · retrieved November 3, 2026 · last checked November 3, 2026
5Commercial Mammalian Manufacturing - KBI Biopharma (opens in a new tab)KBI Biopharma · Provider website · retrieved November 3, 2026 · last checked November 3, 2026
6Mammalian Clinical Manufacturing - KBI Biopharma (opens in a new tab)KBI Biopharma · Provider website · retrieved November 3, 2026 · last checked November 3, 2026
7Pharmaceutical Formulation | Drug Research Formulation Lab – KBI Biopharma (opens in a new tab)KBI Biopharma · Provider website · retrieved November 3, 2026 · last checked November 3, 2026
8Cell Culture Process Development – KBI Biopharma (opens in a new tab)KBI Biopharma · Provider website · retrieved November 3, 2026 · last checked November 3, 2026
9Analytic Development Process | Analytical Laboratories - KBI Biopharma (opens in a new tab)KBI Biopharma · Provider website · retrieved November 3, 2026 · last checked November 3, 2026
10Mammalian Cell Line Development - KBI Biopharma (opens in a new tab)KBI Biopharma · Provider website · retrieved November 3, 2026 · last checked November 3, 2026
11Microbial Clinical Manufacturing - KBI Biopharma (opens in a new tab)KBI Biopharma · Provider website · retrieved November 3, 2026 · last checked November 3, 2026
12About Us - KBI Biopharma (opens in a new tab)KBI Biopharma · Provider website · retrieved November 3, 2026 · last checked November 3, 2026
13Our Locations - KBI Biopharma (opens in a new tab)KBI 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

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