GenScript is your trusted Cell and Gene Therapy partner for custom manufacturing of synthetic single guide RNA (sgRNA) supporting non-viral gene and cell therapeutics development. GenScript is offering now current Good Manufacturing Practices (cGMP) manufacturing from our newly added State-of-the-Art Production Facility with multiple dedicated cGMP production lines providing CRISPR sgRNA with the necessary documentation required for successful IND submission and clinical trials, including Drug Master File (DMF) to streamline your regulatory review process.

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


State-of-the-Art Production Facility

  • cGMP manufacturing of 30mg up to gram quantities per batch
  • Compliant with FDA/EMA/PMDA/NMPA regulations

Comprehensive QA/QC Documentation

  • 10+ QC options supporting global IND filing needs
  • US Type II DMF and/or CMC filing support

Trusted Partner from Bench to Clinic

  • Successfully delivered 100+ cGMP batches
  • 6 IND approvals
Production Facility Banner Production Facility
cGMP manufacturing facility opened 2022

cGMP production environment

Clean suite with class A isolator in a class C background

Sterile filtration and aseptic fill finish

Process development and optimization

CQA/CPP confirmed

Flexible batch scale from 30 mg – 1 g

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 sgRNA and payloads manufacturing


Quantity µg - mg mg - g mg - g
Purification & Analysis Desalt or HPLC 90% NGS Full Report
Analytical Methods Suitably Verified Qualified Validated
Documentation COA Customizable Full GMP
Facility Controlled, Unclassified Classified upon request Grade C+A (Isolator), capable of sterile product
Materials Traceable with vendor management Traceable with vendor management Traceable with vendor management + ID testing

cGMP Production Workflow


Support from Research 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.


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.



Get in Touch
with GenScript
GenCRISPR cGMP sgRNA Services

Get in Touch with GenScript GenCRISPR cGMP sgRNA Services
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