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NGS mRNA drug safety testing

NGS mRNA drug safety testing

RNA drugs are a new type of biotechnology drug, whose core is to use synthesized mRNA molecules to transmit specific genetic information to promote the production of specific proteins in cells. During the preparation of these mRNA drugs, double stranded RNA (dsRNA) residues are often generated, which may trigger adverse immune reactions or potential cytotoxicity. Therefore, it is crucial to avoid the production of dsRNA as much as possible in mRNA sequence design and optimization, remove dsRNA residues during mRNA purification, and detect dsRNA residues after purification to ensure quality control in the production process and the safety and effectiveness of the final drug product. At present, the industry generally uses ELISA and other methods to detect residual dsRNA, but there is a lack of in-depth understanding and research on the sequence types and characteristics of dsRNA itself.

GentleGen has launched a unique and innovative IVT mRNA dsRNA residue analysis and detection method in the industry, which utilizes emerging high-throughput sequencing technology (NGS) combined with a self-developed bioinformatics analysis process to analyze the hotspots of dsRNA production in in in vitro transcribed mRNA, assisting in mRNA sequence design optimization and improvement, and reducing the production of dsRNA. GentleGen is committed to promoting the application of emerging technologies such as high-throughput sequencing in the quality and safety evaluation of biomedicine, accelerating the research and application of nucleic acid drugs.
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Service Advantages

Industry innovative mRNA full-length sequence confirmation technology, comprehensive mRNA analysis and detection solution

Industry innovative mRNA full-length sequence confirmation technology, comprehensive mRNA analysis and detection solution

01/03
MRNA sequence coverage is comprehensive, and one sequencing can cover 5'UTR, CDS, 3'UTR, and Poly (A) tail

MRNA sequence coverage is comprehensive, and one sequencing can cover 5'UTR, CDS, 3'UTR, and Poly (A) tail

02/03
Scheme compatibility, detection with or without poly (A), complete experimental records and reports, supporting drug application

Scheme compatibility, detection with or without poly (A), complete experimental records and reports, supporting drug application

03/03

Service Period

Service type Service Content Sample requirements Delivery Content Price
NGS safety evaluation of nucleic acid drugs Full length mRNA sequence confirmation (Sanger method) In vitro transcription of mRNA; Concentration≥ 200ng/μ l. Volume≥ 25μ L. LNP sample delivery requirements≥ 0.3mg/mL,≥ 200μ L Experimental report on sequence splicing results and raw sequencing results (optional) Evaluate based on actual project
mRNA full-length sequence characterization (high-throughput sequencing method)
IVT mRNA dsRNA residue analysis and detection (high-throughput sequencing method) Original sequencing results, dsRNA analysis and detection report
T7 RNA polymerase fidelity analysis Polymerase Fidelity Analysis Test Report

Service Process

Sample reception

Sample reception

Sample quality inspection

Sample quality inspection

Sample preparation

Sample preparation

Sample sequencing

Sample 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.

Sequence stitching result

Original sequencing results

DsRNA analysis and detection report

Verification report (optional)

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.

Data Download

Data Download

Product manual download、order form

ordering information

ordering information

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

Case Sharing

Confirmation of mRNA full-length sequence using Sanger method

Confirmation of mRNA full-length sequence using Sanger method

Characterization of mRNA full-length sequence using high-throughput sequencing method

Characterization of mRNA full-length sequence using high-throughput sequencing method

IVT mRNA dsRNA residue analysis and detection (high-throughput sequencing method)

IVT mRNA dsRNA residue analysis and detection (high-throughput sequencing method)
Antisense RNA ratio

Integrity analysis of T7 RNA polymerase

Integrity analysis of T7 RNA polymerase
The effect of different RNA base modifications on the error rate of T7 polymerase

Integrity analysis of T7 RNA polymerase

Integrity analysis of T7 RNA polymerase
The effect of different RNA base modifications on the types of error rates of T7 polymerase

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