Overview

GenScript is your trusted partner for custom manufacturing of clinical-grade synthetic guide RNA (gRNA), supporting the development of non-viral gene and cell therapeutics using a variety of CRISPR gene editing systems, including Cas9, Cas12a, prime editing, base editing, and more. We offer current Good Manufacturing Practice (cGMP) manufacturing from our state-of-the-art production facility, featuring multiple dedicated cGMP production lines. Our cGMP gRNA is provided with comprehensive documentation necessary for successful IND submissions and clinical trials, including a Drug Master File (DMF) to streamline your regulatory review process.

Our standard turnaround time for cGMP gRNA is just 30 days.

Partner with GenScript to accelerate your therapeutic pipeline from early-phase research to clinical applications.

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State-of-the-Art Production Facility

  • cGMP manufacturing of 40 mg to grams quantities per batch
  • Compliant with FDA/EMA/PMDA/NMPA regulations
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Comprehensive QA/QC Documentation

  • 10+ QC options supporting global IND filing needs
  • US Type II DMF and/or CMC filing support
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Trusted Partner from Bench to Clinic

  • Successfully delivered 100+ cGMP batches
  • 9 global IND approvals
cGMP Production Facility cGMP Production Facility

cGMP production environment

Class A (ISO 5) isolators & segregated manufacturing in Class C (ISO 7) clean rooms

Sterile filtration and aseptic fill finish

Process development and optimization

CQA/CPP confirmed

Flexible batch scale from 40 mg to grams

QA/QC & Documentation Banner QA/QC & Documentation

Manufacturing Summary Report, TSE/BSE Statement

Batch Records based on Master Batch Record and Change Control System

Identity, purity, sterility, etc. clearly defined

cGMP-compliant material and supplier management

Validated QC testing procedures

Long-term stability testing under various solutions and storage conditions

Established QMS for training, process deviations, and CAPA

GenScript Expands cGMP Capabilities for CRISPR gRNA and payloads manufacturing

Specifications

RUO INDEdit cGMP
Production Site RUO site cGMP site cGMP site
Application/ Purpose Discovery & development Preclinical research to ​
IND enabling studies
Phase I, II, III ​
& commercial
Production Scale µg to g scale 35 mg – 5 g 35 mg – 5 g
Purification Desalt/ HPLC HPLC HPLC
Quality Management ​
System (QMS)
ISO 9001 cGMP-compliant​
(simplified)
cGMP-compliant
Batch Record x
Analytical Method​
Qualification/ Validation​
Not required​ Not required​
​ (Platform Standards)​
Validated
QC Tests​ Basic Basic + Advanced​ Basic + Advanced + Premium​
QA Release​ Yes Yes Yes
Delivered ​ Documentations​ 1.Cert. of Analysis (CoA)​
2.TSE/BSE Statement​
1.Cert. of Analysis (CoA)​ ​
2.TSE/BSE Statement​ ​
1.Cert. of Analysis (CoA)​ ​
2.TSE/BSE Statement​ ​
3.Cert. of Compliance (CoC)​ ​

Note: *Engineering Run service also available upon request​

cGMP Production Workflow

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Your reliable partner from bench to clinic

GenScript offers the manufacturing expertise, capacity, and validated platform processes to accelerate your non-viral gene and cell engineering from early-phase research to the clinic. Our complete suite of phase-specific CRISPR gene editing solutions provides the flexibility to support your project at any stage.

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Partner with GenScript to reliably source CRISPR gene editing materials in the quantity and purity you need, and with the documentation required for successful IND submission and clinical trials.

Strategic Cooperation

Resources

White Paper: From Concept to Clinic: Navigating the Regulatory Path of CRISPR-based Therapeutics

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White Paper: Ensuring Quality and Compliance: CMC Strategy for CRISPR-based Therapeutics

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White Paper: Ensuring Translational Success: Preclinical Study Design for CRISPR-based Therapeutics

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FAQs

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with GenScript
GenCRISPR cGMP gRNA Services

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