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NGS cell therapy safety testing

NGS cell therapy safety testing

Adeno associated virus (AAV) is a structurally simple single stranded DNA virus. Recombinant adeno-associated virus vector (rAAV) is derived from non pathogenic wild-type adeno-associated virus, which has good safety, wide host cell infectivity, and long in vivo expression time. Currently, the scientific community generally believes that AAV does not cause human diseases and is therefore considered the most promising gene therapy vector.

Recombinant adeno-associated virus (rAAV) has been widely used in gene therapy due to its safety and efficacy. However, in the packaging and clinical process of AAV virus, there are issues such as high shell rate, low integrity, high impurity DNA residue, and potential genome integration risks, which seriously affect the safety and effectiveness of clinical treatment. To this end, GentleGen has launched the AAV high-throughput sequencing safety assessment platform AAV NGSafety™。 This platform utilizes second-generation and third-generation sequencing technology to analyze the purity of AAV virus packaging, the integrity of AAV target sequences, the accuracy of ITR regions, and potential insertion sites of AAV genomes. Its aim is to help customers in gene therapy drug development optimize AAV production processes, characterize potential safety risks of AAV gene therapy vectors, and accelerate the faster and safer delivery of AAV gene therapy drugs to patients.
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Service Advantages

Validate according to FDA, EMA, and ICH guidelines to ensure that the method meets regulatory requirements at different stages of drug development

Validate according to FDA, EMA, and ICH guidelines to ensure that the method meets regulatory requirements at different stages of drug development

01/04
Strict methodological validation based on standard samples to ensure the accuracy, sensitivity, and stability of the method process

Strict methodological validation based on standard samples to ensure the accuracy, sensitivity, and stability of the method process

02/04
Rich project experience: We have collaborated with multiple leading clients in the AAV gene therapy industry to assist in the clinical application of multiple AAV gene therapy drugs

Rich project experience: We have collaborated with multiple leading clients in the AAV gene therapy industry to assist in the clinical application of multiple AAV gene therapy drugs

03/04
One stop AAV quality testing service, short cycle, visualized project analysis report

One stop AAV quality testing service, short cycle, visualized project analysis report

04/04

Service Period

Service type Sample requirements Detection method Completion cycle (working days)
AAV virus genome purity detection Provide AAV virus or AAV genomic DNA Second generation sequencing Evaluate based on specific project
AAV sequence accuracy verification Second generation sequencing
AAV virus genome integrity detection Third generation sequencing
AAV virus genome insertion site detection Provide cells, tissues, or corresponding genomic DNA treated with AAV virus Second generation sequencing

 

Service Process

Sample reception

Sample reception

Sample quality inspection

Sample quality inspection

Library preparation

Library preparation

Library sequencing

Library sequencing

Issue a report

Issue a report

Delivery Results

If you have any other requirements, please send an email to order@gentlegen.com,We will serve you as soon as possible.

Original sequencing results

Analysis and Testing Report

Service&Support

Inquiry and ordering

Inquiry and ordering

 

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.

Download

Download

Product manual download、order form

ordering information

ordering information

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

Sample Preparation

Provide AAV virus or AAV genomic DNA

Provide AAV virus or AAV genomic DNA

Provide cells, tissues, or corresponding genomic DNA treated with AAV virus

Provide cells, tissues, or corresponding genomic DNA treated with AAV virus

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