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CGMP CRISPR Manufacturing & Services

Accelerate your CRISPR therapeutic development with our CGMP gRNA manufacturing, CGMP Cas enzyme services, and regulatory support for IND applications. Our end-to-end services ensure compliance, efficiency, and a faster path to clinical trials.

“We’ve looked at every angle that CRISPR is being used by researchers and sought ways to make that process better, more efficient, and safer."

Mark Behlke, MD, PhD

Chief Scientific Officer
IDT

Support at every stage

Transition seamlessly from discovery to therapeutic development with our custom RUO, engineering run, and CGMP CRISPR manufacturing solutions.
Research (RUO) Engineering Run cGMP
Compliance ISO 9001-2015
ICH Q7 for pre-clinical and early phase clinical trail material
Quality Control Basic characterization tests*
Qualified Testing Methods
Quality Control Testing*
Out-of-Specification Investigation
Customized Part Number with Customized Final Specification
Certificates Certificate of Testing
Certificate of Origin (TSE/BSE Certificate)
Batch Record Traceable
Custom
QA Review and Release
Raw Materials Traceable
Inspection and Release #
Environment Temperature and Humidity Controls
ISO Class 8 Clean Rooms
Environmental Monitoring
Dedicated Laboratory Suite During Manufacturing
Additionals Regulatory support

* = ESI-MS and OD to confirm identity and yield
• Standard Quality Control Testing includes: Concentration, Appearance, Elemental Impurities per , Residual Solvents per , Endotoxin per and Bioburden per
W = Inspection of release for RUO will follow ISO 9001 standard and ICH Q7 process for Engineering run and cGMP manufacturing
† IDT Controlled
CGMP gRNA products are manufactured in accordance with ICH Q7, 21CFR210, 211, and parts of 600. IDT engineering runs and CGMP gRNA are for development and investigational use only. The performance characteristics of this product have not been established.  This product is not intended to be used as final drug product. The purchaser is solely responsible for all decisions regarding the intended use of the product and any associated legal or regulatory obligations.