Pharmaceutical NGS Safety Testing Services

With the continuous expansion of cell and gene therapy (CGT) in clinical applications, the demand for quality control of these advanced therapeutic products is also increasing. Next Generation Sequencing (NGS) technology is gradually becoming a key analytical tool in the field of CGT due to its high throughput, accuracy, and sensitivity. NGS can deeply analyze nucleic acid sequences to identify structural variations, insertion or deletion mutations, point mutations, fusion genes, etc. in the genome, comprehensively evaluating the safety, stability, and effectiveness of cell and gene therapy products.

At present, regulatory agencies in various countries are gradually increasing their requirements for quality testing of CGT products and advocating the use of advanced technologies such as NGS. Regulatory agencies such as the US FDA, European EMA, and Chinese NMPA are actively encouraging the use of NGS as an analytical and testing tool to improve the quality control level and patient safety of therapeutic products. For example, NGS technology can be used to verify the insertion location of therapeutic genes, detect potential off target effects, evaluate the efficiency of gene editing, and monitor genomic integrity during the treatment process. The application of NGS technology in biopharmaceutical analysis and testing not only promotes the optimization of CGT product development and production processes, but also provides solid data support for ensuring product safety and effectiveness in regulatory audits and clinical applications.

GentleGen launches innovative NGSafety to meet the quality analysis and testing needs of CGT products ™ Technical platform, including mRNA NGSafety ™、CRISPR-NGSafety ™、AAV-NGSafety ™、Lenti-NGSafety ™ To meet the requirements of regulatory agencies with strict quality control systems, precise sample preparation processes, and bioinformatics analysis capabilities. GentleGen platform has assisted multiple clients in the CGT field to successfully apply for IND in China or the United States for their R&D pipelines.

Service Type

NGS mRNA drug safety testing

NGS CRISPR therapy safety testing

NGS cell therapy safety testing

NGS protein drug safety testing

Safety evaluation of protein drug NGS^{Coming Soon}

Service type	service content	Sample requirements	Delivery Content	Complete cycle
Safety evaluation of NGS nucleic acid drugs	MRNA full-length sequence validation	In vitro transcription of mRNA; Concentration ≥ 200ng/μ l; Volume ≥ 25 μ L; LNP sample submission requirements: ≥ 0.3mg/mL, ≥ 200 μ L	Experimental report on sequence splicing results and raw sequencing results (optional)	Evaluate based on actual project
	CircRNA sequence validation/circRNA interface validation
	Confirmation of mRNA full-length sequence
	Analysis and detection of residual sequences of IVT mRNA and dsRNA		Original sequencing results, dsRNA analysis and detection report
	Integrity analysis of T7 RNA polymerase		Polymerase Authenticity Analysis Test Report
Safety evaluation of gene editing NGS	Gene editing efficiency testing - amplicon sequencing	Provide PCR products or genomic DNA; The amount of genome provided is determined by the number of loci that need to be detected	Original sequencing results, analysis and testing reports
	Off target validation of gene editing - high-throughput amplification sequencing
	Whole genome WGS off target detection	Provide cellular or genomic DNA
	Off target detection of gene editing in vivo
	Off target detection of gene editing in vitro
Safety evaluation of gene therapy drug NGS	Purity testing of AAV virus genome	Provide AAV virus or AAV genomic DNA	Original sequencing results, analysis and testing reports
	AAV sequence accuracy verification
	AAV virus genome integrity testing
	Detection of AAV virus genome insertion sites	Provide cells, tissues, or corresponding genomic DNA treated with AAV virus
Safety evaluation of cell therapy drug NGS	Detection of virus vector integration sites	Provide cells, tissues, or corresponding genomic DNA treated with lentiviral vectors	Original sequencing results, analysis and testing reports

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Service Process

Sample Acceptance

Sample quality control

Sample Preparation

Sequencing of specimens

Issue a report

Service Advantages

One stop production and analysis testing

Meet the requirements of mRNA analysis and detection from R&D to commercialization stage from compliance requirements, process development, analytical method development, and quality analysis platform.

01/04

quality standard

The quality standards strictly follow the guiding principles of the National Center for Drug Evaluation, and the processes are regularly optimized

02/04

Innovative mRNA full-length sequence detection method

Innovative mRNA full-length sequence detection method: One experiment can complete full-length detection

03/04

Can provide diversified sequencing platforms

We can provide diversified sequencing platforms: first generation, second generation, and third generation sequencing.

04/04

Application Area

Gene Therapy

Antibody Drugs

Cell Therapy Solutions

Nucleic Acid Drugs

Service&Support

询价与订购

Directly log in to GentleGen GBS Online Ordering System，Automatically obtain quotes and place orders;stay“Data Download”Download the corresponding service subscription form and send an email. We will provide you with a quotation as soon as possible.

资料下载

Product manual download、Order Form

订购信息

mailbox:marketing@gentlegen.com Phone: 0512-67998818, ext. 8888

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