Clinical CRISPR Solutions

Your Guide To GMP CRISPR Success

Your Trusted Partner To The Clinic

Your success is our priority. From the initial stages of planning to the delivery of GMP-ready CRISPR solutions, our mission is to simplify your path to clinical success. With a proven track record of providing GMP-grade materials for groundbreaking therapies, we ensure your projects are backed by unwavering reliability and precision. In fact, we have produced 200+ batches of GMP-grade guide RNAs successfully delivered since 2020, supported 12 approved IND submissions, and excelled in 40+ customer quality audits - clear proof of our commitment to excellence in clinical-grade manufacturing. Our tailored regulatory guidance helps you meet FDA and global compliance standards, while our engineered CRISPR nucleases enhance the safety and efficacy of your therapies. But what truly sets us apart is our commitment to full collaboration, clear communication, and unwavering support to keep your program on track and focused on achieving its therapeutic milestones.

Dedicated Customer Success

We prioritize your goals, working closely with your team to ensure the success of your program. Our team provides:

Expert Consultation
Direct access to scientific advisors, regulatory experts, and quality assurance specialists who help design and optimize your GMP project. From guide RNA design to IND preparation, our experts offer actionable guidance tailored to your objectives.
Best-In-Class Support
A dedicated account manager and highly responsive technical support team that proactively addresses any challenges quickly and thoroughly. We’re with you throughout troubleshooting issues, assisting with documentation, and ensuring you always have the answers and resources you need.
Transparent Communication
Regular updates and clear dialogue throughout production so you’re never in the dark about your project’s status. We maintain open lines of communication to keep your project on track, adjust to your feedback, and provide full visibility into timelines and results.

Simplified, Reliable Processes

We focus on simplifying your workflows, delivering exceptional quality, and supporting faster, more reliable outcomes for your program.

Tailored Project Plans
Custom-designed strategies built around your specific requirements to meet program goals effectively. We integrate your unique needs - from selecting the optimal guide RNAs and nucleases to aligning with your regulatory strategy-into a plan that positions you for success.
Streamlined Workflows
Efficient processes that reduce delays and maintain consistency throughout production. We ensure every step—from sample preparation to data analysis—is optimized for speed and accuracy, minimizing bottlenecks and maximizing productivity.
Flexible Solutions
Adaptable services that make it easy to scale capabilities as your program matures. Whether you need to increase batch size, incorporate new CRISPR innovations, or navigate evolving regulatory requirements, we adjust our process to support your next steps seamlessly.

Step-by-Step Guide to Starting Your GMP Project With Synthego

Verify that the supplier follows a validated QMS with stringent controls at every stage of production. A true GMP manufacturer will have an established QMS that covers deviation management, proper environmental monitoring, equipment validation, change control systems, and more. For example, formal change control procedures should be in place to evaluate and approve any changes to materials, processes, or analytical methods before implementation. The QMS should align with industry guidelines like ICH Q10 and ensure compliance at every stage of production.

1. Initial Consultation

Your GMP project with us begins with a comprehensive consultation to ensure we fully understand your clinical goals and operational needs. During this kick-off session, you’ll speak directly with our experts about your target timelines, regulatory strategies, and any specific challenges you are facing. Whether you’re navigating your first IND application or advancing a late-stage clinical trial, we’ll outline a clear and efficient path tailored to your success, providing actionable insights based on our extensive GMP expertise.

2. Customized Project Design

Collaborating closely with you, we co-develop a detailed project plan that aligns with your clinical goals and addresses your specific needs. This collaborative approach ensures that every detail - from production timelines, batch scale, and QC assays to regulatory documentation and recommended CRISPR solutions - is designed to support your therapeutic development. By working together, we create a clear roadmap that integrates your project’s unique requirements, helping you stay on track to meet critical milestones and satisfy regulatory expectations confidently.

3. GMP CRISPR Synthesis Execution

After you approve the project design, we move into the manufacturing phase. Your specific CRISPR molecules will be produced in our state-of-the-art, GMP-qualified facilities, utilizing validated processes built to meet the highest standards of quality and consistency. Throughout this step, we maintain transparent communication - you’ll receive regular updates so you always know the status of production and can plan accordingly.

Learn more about Synthego's cGMP Manufacturing & Quality Process

4. Molecule & Documentation Delivery

When your GMP materials are ready, we’ll deliver your molecules along with a comprehensive documentation package to support your regulatory filings. This includes Certificates of Analysis (CoA), batch records, disposition forms, Certificates of Conformance and any other required documents to certify that your product meets all specifications. Each document is prepared to facilitate smooth regulatory review and give you confidence in the integrity and compliance of your therapeutic materials as you move forward to clinical application.

5. Ongoing Support

Our partnership doesn’t end with the delivery of your guide RNAs - we continue to support you through regulatory submission and beyond. We provide expert assistance with Chemistry, Manufacturing, and Controls (CMC) documentation to simplify your IND or CTA submissions, along with access to a comprehensive Drug Master File (DMF) for reference in your regulatory package. Post-delivery, our team remains available to support you with regulatory inquiries and resolve any technical challenges that may arise during your project. By maintaining open communication and offering tailored guidance even after production, we help ensure your project stays on course, keeping you focused on achieving your therapeutic milestones efficiently and with confidence.

Contact a GMP Specialist

Learn more about our clinical-grade sgRNA offerings.

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