Provider profile

Bionova Scientific.

Biologics CDMOs · Part of Asahi Kasei4,10

Bionova Scientific describes mammalian cell line development, process, analytical and formulation development, and GMP manufacturing of monoclonal antibodies and recombinant proteins from DNA to bulk drug substance in single-use bioreactors, at a facility described as commercial-ready and producing clinical supply. It lists headquarters in Fremont, CA, and is described as a subsidiary of Asahi Kasei.

Website: bionovascientific.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

Analytical development and QC testing1
Cell line development6
Formulation development3
GMP drug substance manufacturing2
Process development1
Stability studies1,3

Platforms and methods

Mammalian cell culture4,5
Single-use bioreactors2

Drug substance / drug product

Drug substance2

Development experience

Development stage

Commercial2Stated as a capability of the GMP facility; commercial products made there are not named in reviewed sources
Phase 31Stated for assay validation (analytical services) only

Modality

Monoclonal antibodies3,5Stated for formulation development experience
mRNA and nucleic acids8Plasmid DNA manufacturing processes stated in a January 2026 partnership announcement; not mRNA manufacturing
Recombinant proteins6,7

Locations

Fremont, United States · Headquarters11

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 / cGMP2,9

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

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Evidence and sources

1Analytical Sciences: Driving Quality and Efficiency in Biopharmaceutical Development - Bionova Scientific (opens in a new tab)Bionova Scientific · Provider website · retrieved November 3, 2026 · last checked November 3, 2026
2GMP Manufacturing of Biologics - Bionova Scientific (opens in a new tab)Bionova Scientific · Provider website · retrieved November 3, 2026 · last checked November 3, 2026
3Formulation Development - Bionova Scientific (opens in a new tab)Bionova Scientific · Provider website · retrieved November 3, 2026 · last checked November 3, 2026
4Bionova: Advancing Biologics Development and Manufacturing - Bionova Scientific (opens in a new tab)Bionova Scientific · Provider website · retrieved November 3, 2026 · last checked November 3, 2026
5Biologics CDMO: Empowering Innovation in Therapeutic Proteins - Bionova Scientific (opens in a new tab)Bionova Scientific · Provider website · retrieved November 3, 2026 · last checked November 3, 2026
6Cell Line Development - Bionova Scientific (opens in a new tab)Bionova Scientific · Provider website · retrieved November 3, 2026 · last checked November 3, 2026
7Bionova Scientific Licenses ATUM’s Proprietary Transposon-Based Gene Delivery Technology to Accelerate & De-Risk Cell Line Development - Bionova Scientific (opens in a new tab)Bionova Scientific · Provider website · retrieved November 3, 2026 · last checked November 3, 2026
8Bionova Scientific and Syenex Forge Strategic Alliance to Expand Access to High-Quality Plasmid DNA for Advanced Therapies - Bionova Scientific (opens in a new tab)Bionova Scientific · Provider website · retrieved November 3, 2026 · last checked November 3, 2026
9Quality Control - Bionova Scientific (opens in a new tab)Bionova Scientific · Provider website · retrieved November 3, 2026 · last checked November 3, 2026
10Bionova Scientific page: bionovascientific.com/2025/03/20/bionova-appoints-bionique-testing-laboratories-as-preferred-provider-for-mycoplasma-testing-services-for-biologics-manufacturing (opens in a new tab)Bionova Scientific · Provider website · retrieved November 3, 2026 · last checked November 3, 2026
11Contact Bionova: Get in Touch with Our Team - Bionova Scientific (opens in a new tab)Bionova Scientific · 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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