Reliable GMP-grade sgRNA 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.
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.
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 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 equipment, facility, material controls in 21 CFR part 58 and provides comparability for nonclinical vs clinical materials |
| Quality Management System |
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 Identity Testing |
Qualified and QA approved vendors Traceable under QMS Material Oversight by QA |
| Validated Cleaning Process | Yes | No |
| Manufacturing Space |
GMP suites segregated for manufacturing steps Synthesis and Purification:
|
Synthesis and Purification:
|
| Delivered Documentation |
Executed batch records Certificate of Analysis Certificate of Conformance with TSE/BSE statement |
Executed batch records Certificate of Analysis |
| GMP sgRNA Available Quality Tests |
|---|
| Appearance |
| Concentration by UV-Vis |
| pH |
| Purity by HPLC-UV |
| Identity by ESI-MS |
| NGS |
| Residual water content |
| Residual solvent content |
| Elemental impurities |
| Endotoxin Testing |
| Bioburden Testing |
| Sterility Testing |
| CCIT |
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.
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
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