Our quality commitment.

At Core Bio, our dedication to guarantee the highest level of excellence in our quality standards is present every day, in every action. 

We take our responsibility to support the robustness of your projects and technology, by de-risking every aspect related to the use of raw and ancillary materials in your process. 

As such, we lead the industry in supplying extensively qualified plant-derived recombinant proteins, with the appropriate grades to be compatible with your cell manufacturing, discovery or therapeutic technology.

    • Animal-derived component free

    • Tag-free

    • Expression system free of endotoxins

    • Statements and technology documentation available

    • High purity (> 95-97%)

    • High bioactivity (EC50 < 0.5 -1 ng/mL)

    • Superior stability

    • Biologically tested with validated methods and additional cell lines for end applications

    • Released with CoAs and SDS

    • Lyophilzed powder (high homogeneity and recovery)

    • Liquid (defined concentration and activity)

    • Flexible packaging and solutions for closed systems

    • Standardized documentation filings

    • Consistent analytical testing procedures

    • Manufacturing batch records

    • Materials traceability (USP and DSP)

    • Stability studies

    • Regulatory documentation packages available

Our center of excellence for recombinant protein production.

Core Bio has implemented a cGMP system and follows corresponding guidelines for raw materials manufacturing, such as USP Chapter <1043> or Ph. Eur. General Chapter 5.2.12.

Our headquarters in Strasbourg, France, are equipped with:

  • Validated cleanroom areas including Class A, C and D.

  • ISO Class 7 + 8 for purification.

  • Final filling under ISO 5.

I Products manufactured under ISO 9001:2015 quality management system certification I

Statements and Certificates

Ensuring quality requires open communication and a strong partnership between you—the manufacturer—and us as your supplier. As you transition from discovery and proof-of-concept to cell manufacturing or clinical trials for a cell therapy program, we support you at every stage, starting from your first interactions with regulatory agencies.

A robust manufacturing process demands rigorous raw material qualification. To support this, we provide comprehensive documentation, including in-depth QC studies, batch-to-batch consistency records, and full material traceability. Our commitment is to ensure the safety and reliability of your cell-based product.

Request quality support

Request quality support

Our QA and QC teams are here to help for questions related to product documentation, certifications and regulatory support