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

GenScript Expands cGMP Capabilities for CRISPR sgRNA and payloads manufacturing

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

Strategic Cooperation

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

Get in Touch with GenScript Custom Protein Services
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