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- Platform not qualified, operations non-cGMP
- Change notifications via Quality Agreement
- The same manufacturing processes as GMP
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.
When it comes to advancing your CRISPR-based therapies, one size doesn’t fit all. That’s why Synthego offers a tiered approach to gRNA manufacturing, designed to meet the unique needs of every stage in your clinical journey. From the speed and flexibility required for early-phase work to the rigor and reliability needed for commercial supply, our three tiers—IND-Enabling, GMP Clinical, and GMP Commercial—provide tailored solutions to support your milestones with precision, compliance, and scalability.
Speed and flexibility for early-phase work with a focus on speed-to-clinic priorities.
Qualified platform for Phase1-Phase 2a with a balance of innovation and transparency.
Strategic partnership for commercial supply.
| 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