Overview

GenScript is proud to offer current Good Manufacturing Practice (cGMP) manufacturing of synthetic single guide RNA (sgRNA) supporting non-viral gene and cell engineering development. Our State-of-the-Art Production Facility operates dedicated cGMP production lines to reliably provide CRISPR sgRNA with the necessary documentation required for successful IND submission and clinical trials.

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

State-of-the-Art Production Facility

cGMP manufacturing
in batches of 30mg – 1g

Comprehensive QA/QC Documentation

10+QC options supporting
global IND filing needs

Trusted Partner from Bench to Clinic

Successfully delivered
30+ cGMP batches

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

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

RUO GMP-like cGMP
Quantity µg - mg mg - g mg - g
Purification & Analysis Desalt or HPLC 90% NGS Full Report
Analytical Methods Suitably Verified Qualified Validated
Documentation CofA 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
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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.

Get in Touch
with GenScript
GenCRISPR cGMP sgRNA Services

Get in Touch with GenScript GenCRISPR cGMP sgRNA Services
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