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![cGMP ssDNA And dsDNA Services Are Here!]( "cGMP ssDNA And dsDNA Services Are Here!")
GenScript’s cGMP Capabilities for CRISPR Guide RNA and HDR Template Manufacturing
Specifications
cGMP INDEdit RUO Production Site cGMP site cGMP site RUO site Application/ Purpose Phase I, II, III
& commercialPreclinical research to
IND enabling studiesDiscovery & development Quality Management
System (QMS)cGMP-compliant cGMP-compliant
(simplified)ISO 9001 Batch Record √ √ x Analytical Method
Qualification/ ValidationValidated Not required
(Platform Standards)Not required QC Tests Basic + Advanced + Premium Basic + Advanced Basic QA Release Yes Yes Yes Delivered Documentations 1.Cert. of Analysis (CoA)
2.TSE/BSE Statement
3.Cert. of Compliance (CoC) 1.Cert. of Analysis (CoA)
2.TSE/BSE Statement 1.Cert. of Analysis (CoA)
2.TSE/BSE StatementNote: *Engineering Run service also available upon request
GenScript’s cGMP Capabilities
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
- Process development and optimization
- Analytical test method development and optimization
- CQA/CPP Confirmation
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
- Identity, purity, sterility, etc. clearly defined
- Scientific sound QC test methods
Stability 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.
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
Free Download
White Paper: Ensuring Quality and Compliance: CMC Strategy for CRISPR-based Therapeutics
Free Download
White Paper: Ensuring Translational Success: Preclinical Study Design for CRISPR-based Therapeutics
Free DownloadStrategic Cooperation
Brian Shy, MD, PhD
Evotec (France) SAS
"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
BRL Medicine Inc.,
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.
Ms. Jiang Hua
CEO - Boan Biotech
“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 developmentWant to know more about our cGMP ssDNA and dsDNA services?
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