Empowering CRISPR-based therapeutic developers with best-in-class cGMP gRNAs and nucleases, unmatched expertise, and proven clinical results.
Synthego is setting a new benchmark in clinical genome editing with cutting-edge CRISPR solutions designed to drive therapeutic breakthroughs. Whether navigating the complexities of regulatory pathways or ensuring the highest standards of clinical-grade manufacturing, we are the trusted partner of choice for organizations around the world. Backed by our industry-leading cGMP production capabilities, regulatory expertise, and proven track record, Synthego empowers researchers to deliver therapies quickly and with confidence. Our credentials make us the logical choice for developers at any stage of their therapeutic pathway. By choosing Synthego, you’re gaining access to a proven engine for clinical success, backed by documented results.
At Synthego, quality is not an afterthought - it’s the foundation of every solution we deliver. Our cGMP-grade CRISPR solutions are manufactured and tested under rigorous standards 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.
Choosing the right GMP supplier requires more than a surface-level review. Not all products labeled "GMP" are created equal. In fact, regulators will hold your organization ultimately accountable for the quality of materials used in your clinical program. It is critical to follow a thorough, step-by-step evaluation process to qualify a GMP supplier.
When choosing a CRISPR partner for clinical development, reliability, expertise, and innovation are non-negotiable. Synthego checks all the boxes, delivering unmatched solutions that put you a step ahead in the race to therapeutics.
Read more about how Synthego can simplify your path to clinic success.
You’ll want to start planning for clinical-grade gRNAs early. This is the time to evaluate scalability, batch-to-batch consistency, and regulatory expectations, as well as factors like cGMP quality, purity, and performance - because the last thing you need is delays or setbacks in your development timeline.
Synthego’s INDe and cGMP-certified gRNAs comply with with the strictest FDA and ICH regulations, integrating seamlessly into your therapeutic development. Both options are fully customizable, aligning with your project’s specific goals while ensuring regulatory compliance and scalability.
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.
Establishing a strong regulatory foundation early in your development process is critical to long-term success. Proactive planning ensures that you can anticipate shifting regulatory expectations and align your methodologies accordingly, minimizing risk and avoiding unexpected setbacks or costly rework later on.
We provide end-to-end regulatory support tailored to the unique complexities of your CRISPR-based therapeutic development, guiding you from strategic pre-IND planning through comprehensive IND submission and post-IND interactions to streamline the process, saving you time and ensuring accuracy on your path to regulatory approval.
Addressing analytical and quality standards early in your development process enables you to identify and resolve potential quality issues before clinical implementation. Doing so ensures regulatory compliance, product consistency, and patient safety, setting a strong foundation for your therapeutic program.
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 regulatory standards, reducing risks for your therapeutic program.
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.
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