GMP Protein Production

Q: What is the production capacity of your facility?

Our facility is equipped to handle batches of 10 liters and 40 liters in culture size for each production run.

Q: What protein expression systems do you offer for GMP proteins?

Bacterial, HEK293, CHO cells and insect cells.

Q: What is the typical lead time for producing GMP-grade proteins?

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.

Q: What are the costs associated with your GMP protein production services?

The costs vary depending on the specific protein and project requirements. Please contact us for an accurate quote - quote request form.

Q: Can you accommodate specific quality control testing or assays required for my project?

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.

Q: Are there any restrictions or limitations on the intended use of the GMP-grade proteins?

While our GMP-grade proteins are crucial components in your final product manufacturing, their direct use in clinical or human injections is not recommended.

Q: Do you offer scale-up services for transitioning from research-grade to GMP-grade protein production?

Yes, we offer the conversion of any of our RayBiotech cataloged RUO proteins to GMP-grade proteins.

Q: What materials are necessary to initiate a project?

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.

Q: Does RayBiotech welcome customer audits?

Yes, we do accept customer audits.

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.

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.

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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?

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How Our GMP Protein Production Service Works

Frequently Asked Questions

Still have questions?

What is the production capacity of your facility?

What protein expression systems do you offer for GMP proteins?

What is the typical lead time for producing GMP-grade proteins?

What are the costs associated with your GMP protein production services?

Can you accommodate specific quality control testing or assays required for my project?

Are there any restrictions or limitations on the intended use of the GMP-grade proteins?

Do you offer scale-up services for transitioning from research-grade to GMP-grade protein production?

What materials are necessary to initiate a project?

Does RayBiotech welcome customer audits?

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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.

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.

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