CRISPR Solutions For Every Milestone

Determining the correct quality level for your CRISPR products at every phase of development can be challenging. From early proof-of-concept experiments to clinical trials, choosing appropriately can significantly impact timelines, costs, and regulatory readiness. Synthego’s suite of offerings - including Research-Grade, INDe, and GMP products - provides flexible, scalable solutions for every stage of your clinical and commercial pipeline.

Each phase of development has unique needs. Here’s a suggested framework to guide your decision:

1. Early Preclinical
   Use Research-grade for cost-effective early research, but be cautious about relying on these for pivotal studies or submission data.
2. Late Preclinical and IND-Enabling Studies
   Transition to Synthego INDe products for pivotal studies and preclinical work where regulatory documentation and consistency are critical.
3. Clinical Trials to Market
   Initiate GMP-grade production as soon as your program transitions to clinical success. From early-phase trials to large-scale manufacturing, this ensures regulatory approval and patient safety.

At the foundation of Synthego's continuum lies our research-grade product suite, designed to provide consistent, high-quality solutions for the early preclinical phase. These products offer an ideal balance between performance and affordability, empowering researchers to confidently explore new therapeutic targets while refining CRISPR workflows. Additionally, every product is crafted using the same attention to quality as our GMP-grade offerings, setting Synthego apart in providing research-grade tools built with clinical rigor in mind.

Our research-grade gRNAs are trusted by leading academic institutions, biotech companies, and pharmaceutical innovators worldwide. With customizable formats and rapid production times, researchers can meet their milestones without delays, knowing they are backed by the gold standard in CRISPR synthesis.

Bridging the gap between early-stage preclinical work and regulatory compliance can be one of the most challenging aspects of developing a CRISPR therapy; it’s the stage where therapy developers often face bottlenecks that can delay or derail progress. Synthego’s INDe (IND-enabling) solutions are specifically designed to address this critical stage, offering a tailored balance of affordability, scale, and rigorous quality to meet the needs of preclinical optimization. Our INDe gRNAs help you validate lead candidates, refine processes, and set a strong foundation for clinical manufacturing.

Synthego’s GMP-grade gRNAs and nucleases set the benchmark for quality, reliability, and compliance in CRISPR clinical manufacturing. Developed under strict Good Manufacturing Practice (GMP) guidelines, these products are tailor-made to meet the precise standards required for IND submissions and therapeutic-grade applications. With Synthego as your partner, you’ll benefit from cutting-edge manufacturing capabilities coupled with the assurance of meeting even the most demanding regulatory requirements.

Having supported over 12 IND submissions for CRISPR therapies, Synthego has become a trusted name in the industry. Leaders continue to rely on us not just for our products, but for the assurance that their work is built on a foundation of excellence. Our GMP offering stands as a testament to our commitment to revolutionize the field of gene editing with therapeutic outcomes in mind.

From the outset, Synthego has been dedicated to building a reputation for quality that is as comprehensive as it is unyielding. Every step of our manufacturing process is designed to exceed industry standards, from initial synthesis through final quality assurance. Our commitment to quality is more than a checkbox; it is integral to maintaining your trust and ensuring the success of your therapies.

Our commitment to excellence means we actively work to innovate our quality control processes, leveraging automation, advanced analytics, and continuous improvement strategies to push the boundaries of what’s possible. These efforts not only enhance product performance but also help you save valuable time and resources by delivering materials that integrate seamlessly into your workflows.