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Complete Clinical CRISPR Solutions

Empowering CRISPR-based therapeutic developers with best-in-class cGMP gRNAs and nucleases, unmatched expertise, and proven clinical results.

Backed by our industry-leading cGMP production capabilities, regulatory expertise, and proven track record, Synthego is the trusted partner of choice for organizations around the world. By choosing Synthego, you’re gaining access to a proven engine for clinical success, backed by documented results.

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Setting the Standard for cGMP CRISPR

500+

cGMP Batches Delivered

14 IND

Submissions Approved

40+

Customer Audits Passed with Excellence

At Synthego, quality is the foundation of every solution we deliver. Our cGMP-grade CRISPR gRNA solutions are manufactured to meet the highest levels of regulatory compliance and reliability. By adhering to FDA regulatory requirements and maintaining globally recognized cGMP certifications, we ensure that every batch we produce meets the exacting needs of therapeutic developers.

We implement extensive quality control testing with innovative analytical methods, compliant with the most current regulatory requirements. Our validated analytical and quality assurance framework guarantees that our clinical solutions consistently meet cGMP specifications and global regulatory standards, reducing risks for your therapeutic program.

Tier 1: IND-Enabling

Speed and flexibility for early-phase work with a focus on speed-to-clinic priorities

  • Platform not qualified, operations non-cGMP
  • Change notifications via Quality Agreement
  • The same manufacturing process as GMP
Tier 1: IND-Enabling

Tier 2: GMP Clinical

Qualified platform for Phase1-Phase 2a with a balance of innovation and transparency

  • Fully qualified manufacturing platform
  • cGMP compliance and documentation
  • Platform improvements with client notification
Tier 2: GMP Clinical

Tier 3: GMP Commercial

Strategic partnership for commercial supply

  • Full Process validation (PPQ)
  • Reserved capacity agreement
  • Locked process with client approval for changes
  • Multi-year life cycle management commitment
Tier 3: GMP Commercial

Flexible Support for Clinical and Commercial Tiers

At Synthego, we understand that every clinical program is unique. That’s why we offer a suite of customizable services designed to meet your specific needs at every stage of development. Whether you’re transitioning from research to GMP production, preparing regulatory submissions, or ensuring long-term stability, our expert team and proven processes are here to support your success.

  • Process Development Optimization: Seamlessly integrate your molecule into Synthego’s platform when transitioning from academic or small-scale manufacturers to commercial GMP production.
  • Regulatory Documentation: Comprehensive CMC/Module 3 Technical dossiers ready for IND or BLA filing, addressing the challenge many biotech companies face in preparing regulatory submissions.
  • Tech Transfer: Process transfer to Synthego’s partner sites for capacity or geographic requirements, demonstrating our commitment to your long-term success.
  • ICG Stability Program: Comprehensive stability studies per ICH Q1A/Q1B guidelines including long-term, intermediate, and accelerated testing to support IND, BLA, and MAA submissions.

Experience True GMP Quality

Step inside Synthego and see quality in action. Join us for a Quality Open House to meet our expert team, explore our GMP capabilities, and gain an inside look at the systems that ensure the highest standards for your clinical programs.
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GMP & Engineered Gene Editors

Your nuclease selection and optimization should be integrated into your development strategies early in the therapeutic design process. By evaluating factors like fidelity, delivery compatibility, and efficiency upfront, you can mitigate potential challenges that could derail clinical translation.

  • GMP SpCas9 bundled with GMP gRNAs are a proven and efficient system.
  • Engineered for CRISPR therapies, novel nucleases, hfCas12Max and eSpOT-ON, are deliver cutting-edge safety and efficiency with simplified licensing to more easily bring therapies to market.
  • Accubase™ is a clinically validated Cytosine Base Editor ensuring better safety with significantly fewer off-targets and chromosomal rearrangements

GMP CRISPR Editors for Every Stage

Manufactured under ISO 13485 and cGMP conditions, Synthego's GMP AccuBase CBE and GMP SpCas9 deliver the quality, consistency, and scalability your clinical programs demand, from early-phase trials to commercialization.
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Learn More About Our Clinical-Grade sgRNA Offerings

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