cGMP Batches Delivered
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.
cGMP Batches Delivered
Submissions Approved
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.
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
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.
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.
CRISPR is shaping the future of cell and gene therapy, turning long-held promises into realities. Advances in genome editing and a deeper understanding of the human genome are driving breakthroughs, with therapies now in clinical trials showing the potential to transform patient outcomes.