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CRISPR to the Clinic and Beyond
Synthetic sgRNA GMP Manufacturing for CRISPR-based Therapeutics and Diagnostics
Synthego is proud to announce a new state-of-the-art Good Manufacturing Practice (GMP) production facility for clinical-grade synthetic single guide RNA (sgRNA). The CRISPR sgRNA GMP manufacturing capability positions Synthego as an ideal partner for biopharmaceuticals and academic entities working towards the development of CRISPR-based therapies and diagnostics.
The Need for GMP-Grade sgRNA in Cell and Gene Therapies
GMP is a set of quality guidelines—developed by the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH)—for ensuring that pharmaceutical products are produced according to quality standards.
GMP-grade guide RNAs may be required, or desired, by researchers who are developing regulated therapeutic or diagnostic products. After they validate their research experiments, they approach a phase 1 clinical trial of therapy, wherein they must develop and validate their manufacturing processes to ensure regulatory compliance.
At this stage, they need trusted partners that can provide high-quality material at scale and be flexible enough to accommodate changes in their product design. Currently, there are a very limited number of GMP facilities that support the growing need for higher purity and GMP grade guide RNA manufacturing for translational research groups that are approaching a clinical trial of their CRISPR-based cell & gene therapy or diagnostic tool.
Synthego’s CRISPR GMP sgRNA Manufacturing for All Stages: Early Phase Research to the Clinic
Synthego has been at the forefront of genome engineering innovation by enabling research in the field through the production of high-quality sgRNAs. With the expanded GMP sgRNA manufacturing facility, Synthego can now provide high-quality sgRNA for every stage of the research phase. Whether you need small or large scale research-grade sgRNA, an intermediate grade “GMP-like” sgRNA, or full GMP-grade sgRNA, Synthego has a custom solution for you, as well as the manufacturing capacity to take on your project.
Our streamlined process, strictly controlled by our manufacturing and quality experts, will ensure that your order runs seamlessly from project initiation through product delivery. Synthego is also flexible to adapt to your sgRNA manufacturing needs, in case your desired sgRNA quantity, quality-grade, or quality needs change through the course of your project.
Our reliable documentation, streamlined process, and flexibility make Synthego an ideal partner for your therapeutics and diagnostic project needs.
"Flexibility, customer support, and rapid turnaround time are key reasons why PACT Pharma selected Synthego."
-Kyle Jacoby, Gene Editing associate director, PACT Pharma
Synthego’s GMP Manufacturing Facility
Synthego’s newly built GMP-compliant facility is located in Silicon Valley and ready to serve you and your needs for high-quality sgRNA. The GMP facility is equipped with the following:
- ISO 7 and 8 clean rooms
- Packout in ISO 5 Class II BSC
- Compliance with ICH Q7, Section 19, ICH Q9, ICH Q10
- Single-pass, HEPA filtered air system
- Continuous monitoring for temperature, relative humidity, and differential pressure
- Fully gowned staff
Synthego’s new GMP facility will enable translational research groups who are developing CRISPR-based cell & gene therapies and diagnostics to move their projects into the clinic. Further queries? Reach out to our genome engineering experts to get your project started.
