Good Manufacturing Practice (GMP) Antibody Services

Custom GMP Antibody Services

Develop validated, GMP-compliant antibodies for use in drug discovery, diagnostic, and cell & gene therapy manufacturing processes. All GMP antibodies are manufactured recombinantly, to ensure consistent performance and secure supply.

We have expertise at all stages of reagent development – from protein generation and validation, to downstream analytics and regulatory support. Choose consistent, scalable, and customizable raw materials when you choose Bio-Techne as a partner.

Request a Custom GMP Antibody
Good Manufacturing Practice (GMP) Antibody Services

Established GMP Quality Management and Regulatory Support

Our USA based, state-of-the-art facilities in Saint Paul Minnesota are licensed by the FDA and include quality-controlled manufacturing spaces dedicated to production under animal-free conditions.

Certifications and regulatory guidelines include:

  • ISO 9001:2015, ISO 13485:2016 certified facility
  • USP Chapter <1043>, Ancillary Materials for Cell, Gene, and Tissue-Engineered Products
  • Ph. Eur. General Chapter 5.2.12, Raw Materials of Biological Origin for the Production of Cell-based and Gene Therapy Medicinal Products
Learn more about our QMS and documentation

FDA/USDA Licensed Facilities 

ISO 9001 & 13485

 

Experienced manufacturing of raw materials

Our teams have decades of experience in reagent development and IVD-certified manufacture, as well as a proven track record producing GMP-grade ancillary reagents for cell therapy clients.

Flexibility to fit into your processes

Start from an existing antibody or generate one from scratch. Customize vial size and formulation to streamline and de-risk your process. Scale up and scale out at your own pace. Tell us your needs – and we’ll customize your project.

Expert support for regulatory affairs

Use our dedicated team for support with process validation and regulatory affairs, to help your reagent transition from initial submission to market authorization. We’ll provide complete documentation every step of that way.