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 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 |
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.
Recent FDA guidelines recommend GMP reagents be used prior to IND enabling studies and clinical trials of novel cell and gene engineering, including for master cell bank generation. To prevent potential regulatory issues, researchers will need to source phase-appropriate GMP reagents and submit detailed production documentation with their IND filing.
Unlike other suppliers, GenScript has the capacity to begin your GMP synthesis project without delay. Contact our VP of Commercial cGMP Operations, Michael Lau, PhD ( [email protected] ) to ensure your project stays on schedule.
