GMP Protein Production
Recombinant proteins, such as cytokines, growth factors, and enzymes, are indispensable in pharmaceutical and biotechnology sectors, serving vital roles in therapeutics, vaccines, diagnostics, research, and bioprocessing. GMP (Good Manufacturing Practice)-certified proteins are meticulously manufactured under precise guidelines to guarantee product quality and consistency for safe and effective use in these applications.
Whether you need to convert one of our RUO (Research Use Only)-grade catalog proteins to GMP-grade or develop a custom GMP-certified protein, our experts are here to help.
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Why You Should Choose Our GMP Protein Production Service
Our state-of-the-art GMP protein manufacturing facility is equipped to meet the escalating demand for top-quality proteins. With the capacity to support mid-to-large-scale production, we offer the perfect balance in quantity while ensuring the highest quality.
As a global provider of >7000 cataloged recombinant proteins, our team has accumulated years of experience in protein expression and manufacturing. This empowers us to produce the highest quality proteins, in strict compliance with GMP guidelines, thanks to our comprehensive quality management system and rigorous quality controls.
- 300 sq. ft. dedicated facility space for GMP protein production with expansion potential to accommodate future supply demands.
- ISO 13485:2016, cGMP, and ISO 17025:2017 certifications.
- ISO 6 clean rooms.
See What Our GMP Protein Production Service Can Do For Your Research
GMP Quality Management
- Comprehensive audits conducted both on-site and online.
- Continuous adherence to cGMP compliant environmental monitoring.
- A team of qualified and highly trained GMP production personnel.
- All production and quality control procedures conducted in strict compliance with GMP regulations.
- Full traceability of production and quality control records.
- Review and approval of quality-related documents by our Quality Assurance team.
- Production processes free of animal-derived components.
- Rigorous inspection of incoming materials to ensure their quality.
- Regular maintenance and calibration of equipment.
- Validation of analytical procedures to ensure accuracy.
- Use sterile water for injection throughout production.
- Material procurement from approved suppliers.
GMP Quality Assurance and Testing Capabilities
- N-terminal sequence analysis.
- SDS-PAGE for protein analysis.
- Endotoxin level testing.
- Host cell DNA content evaluation.
- Host cell protein content measurement.
- Biological activity and functionality assessment.
- Microbial and mycoplasma testing.
- Comprehensive stability data.
- Documentation (lot specific COAs).
Ready to see what our GMP protein production service can do for your research?
How Our GMP Protein Production Service Works
Frequently Asked Questions
Still have questions?
Our facility is equipped to handle batches of 10 liters and 40 liters in culture size for each production run.
Bacterial, HEK293, CHO cells and insect cells.
The development timeframe varies by project and is influenced by factors like the provided raw materials (e.g., template DNA or pre-optimized constructs). Typically, the process takes around 6 to 9 months from start to finish.
The costs vary depending on the specific protein and project requirements. Please contact us for an accurate quote - quote request form.
Yes, we can tailor our services to meet the quality control testing and assay needs of your project. Please contact us to discuss the detailed requirements.
While our GMP-grade proteins are crucial components in your final product manufacturing, their direct use in clinical or human injections is not recommended.
Yes, we offer the conversion of any of our RayBiotech cataloged RUO proteins to GMP-grade proteins.
RayBiotech offers end-to-end services, including gene synthesis, protein expression, and purification. Alternatively, you can supply template DNA or a ready-to-use plasmid, or stable cell lines for us to initiate expression and purification.
Yes, we do accept customer audits.
Still have questions?
Featured Resources
Get additional information to help you advance your studies from articles on the science underlying antibody-based techniques to video protocols, application notes, and more.
