cGMP ssDNA And dsDNA Services Are Here!

Enabling faster CAR-T drug development

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. 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

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

CRISPR Gene Editing

Specifications

	RUO	GMP-like	cGMP
Analytical Methods	Suitably Verified	Qualified	Validated
Documentation	CofA	Customizable	Full GMP
Facility	Controlled, Unclassified	Classified upon request	Grade C+A (isolator), capable for sterile product
Materials	Traceable with vendor management	Traceable with vendor management	Traceable with vendor management + ID testing