CRISPR, an acronym for "Clustered Regularly Interspaced Short Palindromic Repeats," refers to an adaptive immune mechanism found in bacteria and archaea. This system comprises Cas nucleases and guide RNAs (gRNAs) and was initially utilized by microorganisms to recognize and cleave viral DNA, thereby providing immunity against viral infections. It has since been engineered into a powerful gene-editing tool. Following the seminal discovery by Drs. Doudna and Charpentier in 2012 of the molecular mechanism underlying DNA cleavage mediated by the CRISPR-Cas9 system, extensive research and optimization efforts by the global scientific community have advanced this technology into a highly precise and broadly applicable genomic editing platform. Currently, CRISPR-based technologies are widely employed across diverse fields, including gene editing, RNA editing, base editing, molecular diagnostics, and live-cell imaging. They have enabled genetic modifications in a wide range of organisms, including humans, thereby accelerating advancements in both basic research and clinical applications.

To achieve precise gene editing using CRISPR technology, the design of guide RNA (gRNA) and the selection of Cas nucleases are two critical factors. The choice of gRNA depends primarily on the specific type of genetic modification required, such as gene knockout (KO), gene knock-in (KI), base editing, prime editing, CRISPR interference (CRISPRi), or CRISPR activation (CRISPRa). Synthego offers a freely accessible CRISPR design tool available to researchers worldwide, which facilitates the design and selection of optimal gRNA sequences for targeted editing of over 120,000 genes. Furthermore, the appropriate selection of Cas enzymes is essential for experimental success. Cas9, originally derived from Streptococcus pyogenes (SpCas9), was the first widely adopted nuclease and remains the most commonly used. However, a growing range of natural and engineered Cas variants are now available for specialized applications. For example, Cas9 nickase induces single-strand breaks to enhance editing precision, while high-fidelity Cas9 variants significantly reduce off-target effects. Additionally, Cas13, a naturally occurring nuclease, demonstrates considerable potential in molecular diagnostics.

In advancing the application and development of CRISPR technology, Synthego serves not only as a leading provider of integrated CRISPR solutions but also as a strategic partner committed to innovation and customer success. The company supplies all key components required for CRISPR-based gene editing, including gRNA design and synthesis services, as well as a comprehensive portfolio of natural and engineered gene editing enzymes. Its product offerings span research-grade, clinical-grade, and GMP-grade materials, supporting researchers throughout the entire pipeline—from basic research to clinical translation.

Research-grade product for preclinical research and development

Within Synthego's product portfolio, research-grade products hold a central position, specifically developed to support early-stage preclinical research. Notably, these products are manufactured under the same rigorous quality control standards as GMP-grade materials, ensuring high reliability and reproducibility of experimental outcomes. Synthego's research-grade gRNAs have been widely adopted by leading academic institutions, biotechnology firms, and pharmaceutical R&D organizations globally, and are recognized as an industry benchmark in CRISPR-based reagent synthesis. This positions Synthego as one of the few companies capable of delivering research tools that meet clinical-level standards of rigor.

The INDe solution helps optimize the early clinical stage

Establishing a robust bridge between early preclinical research and regulatory compliance remains one of the most significant challenges in the development of CRISPR-based therapies. This transitional phase often acts as a critical bottleneck, potentially resulting in project delays or developmental stagnation. Synthego's INDe solution is specifically designed to address this pivotal stage by providing cost-effective, moderately scalable, quality-controlled, and customizable options tailored to the demands of preclinical optimization. Synthego's INDe gRNAs enable researchers to validate candidate therapeutics, refine editing processes, and establish a solid foundation for clinical-scale manufacturing.

GMP-Grade Products for Clinical Trials

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.

Synthego is a pioneering force in the biotechnology industry, dedicated to advancing the frontiers of CRISPR cell and gene therapies through cutting-edge CRISPR technology and expertise. Our mission is to provide unparalleled access to best-in-class CRISPR solutions at scale, empowering agility in life science research and development from discovery through clinical trials. From streamlined approaches to licensing through full technical and regulatory support from our industry-leading experts, Synthego is enabling greater access to CRISPR technology driving to improved outcomes in patient therapeutic treatments. With its technologies cited in hundreds of peer-reviewed publications and utilized by thousands of commercial and academic researchers and therapeutic drug developers, Synthego is at the forefront of innovation, enabling the next generation of medicines by delivering genome editing at an unprecedented scale.

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