Home » CRISPR Services » Homology-Directed Repair (HDR) Knock-in Templates » cGMP ssDNA and dsDNA Services

Overview

CRISPR non-viral gene insertion methods have gained popularity among researchers. GenScript, as the leading provider of non-viral HDR template solutions, now offers cGMP GenExact™ single-stranded DNA (ssDNA) and GenWand™ closed-end linear double-stranded DNA (dsDNA) services, and GenCircle™ miniaturized circular dsDNA services. These services will enable newer gene and cell therapy R&D programs to advance to IND filing and clinical trials faster and more efficiently.

GenScript’s cGMP manufacturing lines are located in ISO Class 7 cleanrooms, and include ISO Class 5 isolators for aseptic processing operation. The cGMP manufacturing lines operate a Quality Management System that meets the requirements for APIs for use in clinical trials as defined by ICH Q7 Good Manufacturing Practice for Active Pharmaceutical Ingredients, Section 19.

Why partner with GenScript for your non-viral gene and cell therapy reagents?

Non-viral Payload Leader

Innovator and leader in providing long and complex ssDNA and dsDNA HDR templates

Documentation Support

Comprehensive documentation supporting the IND filing process

Enabling Faster Cell Therapy R&D

Non-viral HDR templates in combination with CRISPR technology accelerates cell engineering compared to traditional viral-based engineering.

Early Discovery to Clinical Trials

Different grades of non-viral HDR materials that support your research from early discovery to process development to clinical studies

Fully Customized

Quality, quantity, and product specifications according to your needs

  • GenExact™ ssDNA up to 5000nt in length, 100mg/batch production scale
  • GenWand™ closed-end linear dsDNA up to 10,000nt in length, gram level/batch production scale
  • GenCircle™ miniaturized circular dsDNA up to 50kb in length, gram level/batch production scale

High Quality

Optimized production process to deliver high quality materials

  • Validated QC method for measuring product purity, identity, endotoxin, sterility, residual protein, and stability.
  • Sequence-specific process development ensures high-quality, large-scale production

Our Track Record

  • Successfully delivered 76+ cGMP HDR template batches
  • 4 global IND approvals
Contact An Expert
CRISPR Gene Editing

GenScript Expands cGMP Capabilities for CRISPR sgRNA 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
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​

GenScript’s cGMP Capabilities

Production Environment Banner Production Environment

cGMP designated manufacturing lines/rooms

Controlled production environment

Cleaning process and cleaning records in place

Qualified sterile filtration and aseptic processing fill/finish process

Rx-360 Audit Report (JA-3136) available for licensing—streamline auditing and ensure regulatory confidence, without the need for an on-site audit.
Process Development BannerProcess Development

Process development and optimization

Analytical test method development and optimization

CQA/CPP Confirmation
Quality Assurance & Documentation Banner Quality Assurance & Documentation

Material management and supplier management in compliance with cGMP regulations

Phase appropriate cGMP deployment based on stage of clinical trial and process understanding

Basic Quality Management Systems in place (Training, Deviations, CAPA,...)

Manufacturing Summary Report, TSE/BSE Statement

Batch Records based on Master Batch Record and Change Control system
Quality Control BannerQuality Control

Identity, purity, sterility, etc. clearly defined

Scientific sound QC test methods

Stability Test BannerStability Test

Stability test under various solutions and storage conditions

Prepare/initiate long term stability studies

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.

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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Strategic Cooperation

 "We were very happy to partner with Genscript on critical experiments demonstrating high efficiency and yield of CAR knock-in cells at clinical scale. The long ssDNA produced by Genscript exceeded our expectations and helped us clearly demonstrate the potential for future therapeutic applications using these methods.“

Related reading: Cell and Gene Therapy Companies Leverage GenScript’s cGMP sgRNA Capability to Accelerate Speed to Market




Customers

Brian Shy, MD, PhD

University of California, San Francisco

On November 5, 2024, BRL Medicine Inc. announced that its developed "Targeted CD19 Non-Viral PD1 Site-Specific Integration CAR-T Cell Injection" (BRL-203) has officially received Investigational New Drug (IND) approval from China National Medical Products Administration (NMPA) for the clinical treatment of "moderate to severe refractory systemic lupus erythematosus (SLE).“

GenScript provided core materials, GMP sgRNA, and gene knock-in templates (dsDNA) for this approved non-viral CAR-T therapy. This contributes to the development of safer, more efficient, and cost-effective cell therapies based on CRISPR technology and supports the treatment of a more diverse range of diseases.

Customers

BRL Medicine Inc.,

“GenScript Biotech is a world-leading life science service provider. We fully recognize the services and products that GenScript provides, and expect that our joint efforts will make Boan Biotech’s cell therapy products benefiting patients in clinical practice as soon as possible.”

Related reading: GenScript and Boan Biotech reached a strategic partnership on GMP level GenCircleTM dsDNA, accelerating the process of non-viral CGT development




Customers

Ms. Jiang Hua

CEO - Boan Biotech

Want to know more about our cGMP ssDNA and dsDNA services?

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EMAIL

crispr@genscript.com

PHONE

1-877-436-7274

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