Engineered from PsCas9 (ePsCas9), eSpOT-ON is a high-fidelity CRISPR nuclease validated for developing cell and gene therapies or CRISPR-based therapeutics offered as recombinant protein or mRNA format.
Engineered from the CRISPR Cas12i nuclease, hfCas12Max expands gene editing to new targets with its flexible PAM sequence, ideal for next-generation therapeutic development.
SpCas9 has been extensively studied and is a widely used CRISPR nuclease that enables high-precision gene editing. Cas9 was used in the first FDA-approved CRISPR-based therapy, Casgevy™.
GMP SpCas9 is engineered for exceptional RNP editing efficiency. Manufactured under stringent cGMP conditions, it complies with the FDA and ICH GMP regulations.
Selecting the right CRISPR nuclease is critical to the efficacy and success of your CRISPR experimental goals. Whether you are focused on research, drug discovery, or therapeutic applications, having the right CRISPR nuclease is critical.
CRISPR offers you a whole toolbox of nucleases, each with unique features to tackle specific editing challenges. Whether you're aiming for high precision in therapies or need flexibility to reach tough targets, there's a nuclease to fit your needs perfectly. Think of it as choosing the right tool to power your breakthroughs. Curious to see what’s possible?
Check out all the CRISPR nucleases and find the perfect match for your next big step!
The intellectual property landscape for CRISPR technology is highly fragmented, with overlapping patents and unclear ownership often creating significant barriers to entry. These complexities can lead to extended negotiations, uncertainty around access, and potential delays in program timelines.
Restrictive licensing terms and substantial costs, such as high upfront fees or royalties, strain budgets and limit the scalability of therapeutic programs. Regulatory compliance further adds to the equation, as navigating the approval process requires clear, defensible licenses to avoid potential delays or legal conflicts. Addressing these hurdles requires not only access to high-performance reagents but also transparent licensing models that support scalability, reduce financial strain, and enable seamless regulatory alignment.
With our novel nucleases, you gain access to straightforward IP and licensing solutions tailored to fuel your success. These tools are designed to remove barriers, helping you innovate faster and achieve your therapeutic goals. Explore how our approach to licensing gives you the freedom to focus on groundbreaking advancements.
Choosing a CRISPR nuclease that consistently delivers accurate, precise edits not only streamlines regulatory approvals but also leads to better patient outcomes. Without proven performance data, however, you risk setbacks, particularly when tackling complex genome editing challenges. By selecting nucleases with a demonstrated track record of success across diverse applications and therapeutic advancements, you can confidently address your unique editing needs. Equally important is flexibility; your nuclease must have the versatility to achieve exceptional performance across diverse therapeutic contexts, such as distinct delivery methods, cell types, and genomic targets. A lack of versatility may restrict your ability to address different conditions, reducing the broader utility of your solutions.
SpCas9, the first CRISPR nuclease in an FDA-approved therapeutic, delivers high on-target editing but faces limitations with fidelity and PAM range. To overcome these, our engineered nucleases, eSpOT-ON and hfCas12Max, are tailored for therapeutic use. eSpOT-ON excels in precision, while hfCas12Max offers flexibility with a broader PAM profile, enabling precise edits across diverse genomic regions.
Nuclease production must meet stringent quality control standards, critical to maintaining therapeutic safety and efficacy. Developers must implement robust processes that support consistent, high-quality manufacturing and align with strict regulatory frameworks, which can vary across geographic regions. Scaling requires flexibility to adapt production methods for both preclinical optimization and clinical trials, and adherence to current Good Manufacturing Practices (cGMP) standards. Furthermore, effective documentation and validation processes are essential for regulatory approvals, as any deviation in quality or compliance can delay timelines and increase costs.
At Synthego, quality is embedded in everything we do. Our state-of-the-art technology, rigorous validation processes, and uncompromising standards ensure that every product delivers the precision and reliability you need to achieve your objectives. By prioritizing consistency and innovation, we provide you with tools and services you can trust for reproducible results in even the most complex genome editing projects.
We help you tackle regulatory hurdles by offering nucleases designed for smooth transitions to larger-scale operations and clinical-grade applications. Our team provides tailored support and insights to ensure your projects meet the highest standards while staying on track to achieve your goals. From documentation to navigating precise regulatory pathways, we’re with you every step of the way.
Learn more about how we can simplify the process and empower your success.
You need a partner with a successful track record in delivering high-quality CRISPR solutions including proven nucleases that consistently perform with minimal off-target effects. The right partner provides not only reliable solutions but also technical expertise necessary to address challenges and drive the success of your gene editing projects. Equally crucial is the availability of robust customer support, including technical guidance, troubleshooting, and tailored solutions to address specific project needs. Comprehensive resources, such as detailed product documentation, regulatory compliance insights, and scalable manufacturing processes, further ensure seamless integration into your therapeutic pipelines.
Our CRISPR expertise is focused on empowering you to achieve your genome editing goals with confidence. We bring deep technical knowledge and innovative solutions to support your unique challenges, working closely with you to craft strategies that fit your needs. With our commitment to collaboration and your success, you’ll have the tools, guidance, and partnership needed to tackle even the most complex editing projects.
We’re here to help you achieve your goals with confidence. We understand the unique challenges that come with selecting, adopting, and integrating new nucleases. Whether you’re navigating compatibility issues, optimizing performance to minimize off-target effects, or addressing scalability and regulatory considerations, our team is equipped with the expertise to provide tailored solutions to these complex hurdles. Reach out to connect with us - our goal is to ensure seamless integration of the right nuclease into your therapeutic development. Your success is our priority, and we look forward to partnering with you to solve challenges and achieve impactful results.
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