Reliable GMP-grade sgRNA and SpCas9 for your CRISPR-based therapeutics.
Synthego is your trusted guide for your CRISPR-based therapy development. With our proven track record of successful GMP production, extensive testing and stability studies, and expert quality team to guide regulatory filings for your CRISPR-modified therapy, Synthego can help make your transition to the clinic seamless and rapid.
With 200+ batches of true GMP sgRNAs produced, 12 IND submission approvals supported, and 40+ successful customer audits, it's clear that our CRISPR expertise makes Synthego the leading provider of GMP CRISPR solutions.
Planning to start a GMP project? Contact us to learn more.
Jump to Product Specifications, GMP SpCas9 Nuclease Product Configuration, and GMP Services.
Synthego's full continuum of RUO-to-GMP CRISPR solutions includes high-quality sgRNAs and Cas9 nuclease for use in CRISPR-based therapeutic development. Synthego’s sgRNAs transition seamlessly from RUO for early preclinical work, INDe for IND-enabling studies, and GMP for early clinical trials and our SpCas9 nuclease is offered in both RUO and GMP grades, so you can advance from preclinical to clinical without sacrificing performance or safety.
Synthego's GMP sgRNAs comply with the FDA and ICH current Good Manufacturing Practices (cGMP) regulations including Chemistry, Manufacturing and Controls (CMC) for gene editing components and are manufactured under cGMP to support CRISPR-based therapeutic development. Our GMP sgRNAs provide comparability necessary for successful clinical trials, demonstrating product equivalence when scaling up from INDe or RUO sgRNAs. We recommend use of GMP sgRNA for Phase 1 to pivotal trials.
Synthego’s GMP SpCas9 nuclease is engineered for exceptional ribonucleoprotein (RNP) editing efficiency. Manufactured under stringent cGMP conditions, it complies with the FDA and ICH GMP regulations including Chemistry, Manufacturing and Controls (CMC) for gene editing components. Tailored to support CGT development and clinical research, our GMP SpCas9 ensures reliability and consistency in therapeutic applications.
GMP AccuBase CBE delivers high efficiency and exceptional fidelity, ensuring precise genetic modifications with minimal off-target activity. Manufactured under stringent cGMP standards for therapeutic development compliance, AccuBase provides a safe and reliable solution for advancing clinical and commercial applications. Its RNP format enhances delivery efficiency and reduces potential immunogenicity, supporting seamless therapeutic workflows.
IND-enabling (INDe) sgRNAs comply with the equipment, facility, and material controls in the relevant sections of 21 CFR part 58 on guidelines for Good Laboratory Practice (GLP) for nonclinical laboratory studies. INDe sgRNAs provide comparability for nonclinical to clinical materials, demonstrating product equivalence when scaling up to the GMP-grade sgRNAs necessary for successful clinical trials. We recommend use of INDe sgRNA for IND-enabling studies.
| GMP Gene Editors (SpCas9 & AccuBase) | GMP sgRNA | INDe sgRNA | |
|---|---|---|---|
| Regulatory Compliance | Complies with FDA and ICH cGMP regulations including Chemistry, Manufacturing and Controls (CMC) for gene editing components used in cell and gene therapies | Complies with FDA and ICH cGMP regulations including Chemistry, Manufacturing and Controls (CMC) for gene editing components used in cell and gene therapies | Complies with equipment, facility, material controls in 21 CFR part 58 and provides comparability for nonclinical vs clinical materials |
| Quality Management System |
ISO 13485 21 CFR part 210/211 ICH Q5, ICH Q7, ICH Q9, ICH Q10 |
ISO 9001 21 CFR part 210/211 ICH Q5, ICH Q7, ICH Q9, ICH Q10 |
ISO 9001 ICH Q10 |
| Raw Material Source |
Qualified and QA approved vendors Traceable under QMS Material Oversight by QA QC Identify Testing |
Qualified and QA approved vendors Traceable under QMS Material Oversight by QA QC Identity Testing |
Qualified and QA approved vendors Traceable under QMS Material Oversight by QA |
| Validated Cleaning Process | Yes | Yes | No |
| Manufacturing Space |
GMP suites segregated for manufacturing steps Upstream:
|
GMP suites segregated for manufacturing steps Synthesis and Purification:
|
Synthesis and Purification:
|
| Delivered Documentation |
Certificate of Analysis Certificate of Conformance with TSE/BSE statement |
Executed batch records Certificate of Analysis Certificate of Conformance with TSE/BSE statement |
Executed batch records Certificate of Analysis |
| Gene Editor | GMP SpCas9 | GMP AccuBase |
|---|---|---|
| Origin | E. coli | E. coli |
| Concentration | 10.0 mg/ml | 10.0 mg/ml |
| Fill Volume (mL) | 0.3 | 0.1 |
| Storage Buffer | 30 mM Tris, pH 7.4, 300 mM NaCl, 50% Glycerol, 0.1 mM EDTA | 30 mM Tris, pH 8.0, 300 mM NaCl, 1 mM DTT, 0.1 mM EDTA, 50% Glycerol |
| Storage | Recommended storage at -20±5°C. Avoid repeated freeze-thaw cycles | Recommended storage at -80±10°C. Avoid repeated freeze-thaw cycles |
| Stability | At storage temperature of -20±5°C, the shelf life is 18 months from the manufacturing date. | At storage temperature of -80±10°C, the shelf life is 2 years from the manufacturing date. |
| Shipping | Shipped with dry ice package and temperature sensor tracking. | Shipped with dry ice package and temperature sensor tracking. |
At Synthego, our comprehensive analytical and regulatory services for GMP and INDe sgRNA and GMP SpCas9 are designed to ensure unparalleled quality, compliance, and reliability for clinical applications.
With fully customizable study designs, we offer flexibility in setting specific temperatures, timepoints, and release criteria to align with your project’s needs. Paired with stability-indicating analytical methods, our services provide the robust data you need to support regulatory submissions and ensure reliable therapeutic performance.
Performed under GMP conditions, our advanced analytical services to ensure compliance in accordance with FDA and ICH guidelines for gene editing components used in cell and gene therapies.
| GMP sgRNA Available Quality Tests | GMP Gene Editor Quality Tests |
|---|---|
| Appearance | Appearance |
| Concentration by UV-Vis | Concentration by UV-Vis |
| pH | pH |
| Purity by HPLC-UV | Identity by electrophoresis |
| Identity by ESI-MS | Purity by RP-HPLC |
| NGS | Purity by SEC-HPLC |
| Residual water content | Purity by NR-CE |
| Residual solvent content | Purity by R-CE |
| Elemental impurities | Activity |
| Endotoxin Testing | Residual DNase |
| Bioburden Testing | Residual RNase |
| Sterility Testing | Residual Host Cell Protein |
| CCIT | Residual Host cell DNA |
| Endotoxin Testing | |
| Sterility Testing |
In complement with GMP sgRNAs and nucleases, Synthego provides pre- and post-IND/IMPD regulatory expertise and support, including translating feedback from the regulatory bodies, as well as authoring the relevant gRNA CMC sections, referencing our Drug Master File (DMF) for convenient and comprehensive IND/IMPD submission.
Learn more about Synthego’s Regulatory Expertise and Support
Gene knockout efficiency was analyzed in nucleofected 293T, Jurkat, and primary T cells using TIDE analysis. Results show >85% editing efficacy across all three cell types, comparable to a leading supplier.
Every batch of GMP SpCas9 activity is assessed using an in vitro cleavage assay. The results indicate that the activity of three different batches (Lots 1-3) exceeds 85% and is consistent across different batches.
GMP SpCas9 purity assessed by Tris-Bis-PAGE against a reference standard (RS). The results indicate the purity exceeds 95%.
Long-term stability data (0-18 months) of three batches of GMP SpCas9 nuclease shows high stability and batch-to-batch consistency. As shown in the figure, purity remains higher than 95% (by RP-HPLC and SEC-HPLC) over 18 months. Additionally, the in vitro cleavage activity shows that the product maintains high activity over 18 months, with no obvious downward trend.
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