Nucleic acid drugs are a new class of biopharmaceuticals that have been extensively researched and developed for the treatment of a wide range of diseases, including cancer, infectious diseases, and genetic disorders. Currently, the forms of nucleic acid drugs mainly include small nucleic acid drugs (siRNA, ASO, miRNA, tRNA, etc.), linear mRNAs (non-self-replicating and self-replicating mRNAs) and cyclic RNA drugs. The quality and safety validation of mRNA drugs is particularly important due to their R&D advantages and potential application value in the field of disease prevention and treatment. Currently, different national pharmacopoeias and drug regulatory agencies have issued a number of guidelines for mRNA drug development and mRNA quality analysis and testing, which provide preliminary guidance and recommendations for mRNA drug development and quality analysis methods.

Taking the U.S. Pharmacopoeia as an example, specific recommendations for mRNA sequence accuracy, concentration, integrity, purity, potency, safety, appearance and other characteristics and the corresponding commonly used testing methods are given, and the following summarizes the content and recommended methods for release testing of mRNA raw materials.

Currently, traditional platforms such as molecular biology, cell biology, biochemistry and physicochemical analysis are mainly used for biologics analysis and testing in the industry. However, with the rise of new therapeutics such as nucleic acid drugs and Cell & Gene Therapy (CGT), the potential of high-throughput sequencing (NGS) and other cutting-edge technologies in biopharmaceutical analysis, detection and safety evaluation is gradually being emphasized by the industry. JUNJI BIO will launch a series of services focusing on the application of NGS and other cutting-edge technologies in the field of mRNA and CGT analysis and detection. In this issue, we will launch JUNJI BIO's innovative mRNA sequence full-length confirmation service (Sanger method), which comprehensively covers mRNA 5'UTR, CDS, 3' UTR and Poly (poly) sequencing. UTR, CDS, 3' UTR and Poly(A) tail sequences.

Sequence accuracy of mRNA is one of the key quality attributes in the quality and safety evaluation of mRNA drugs, and it is a basic requirement of drug regulatory agencies to perform comprehensive and accurate sequence confirmation and validation to ensure the quality and safety of drugs.Sanger sequencing is a recognized means of corroboration of sequences; however, methods based on traditional post-reverse transcription PCR and sequencing are unable to detect the mRNA poly(A) tail information, and need to identify the number of poly(A) by other means after cutting the poly(A) tail separately. In order to solve this challenge, JunBio has launched an innovative mRNA full-length sequence corroboration service, which can comprehensively cover mRNA 5'UTR, CDS, 3'UTR and Poly(A) tail sequences by Sanger sequencing through technological upgrades and unique sample preparation solutions, providing mRNA drug discovery and development with efficient, accurate and comprehensive sequence confirmation solution for mRNA drug discovery and development.

1. Industry innovative mRNA full-length sequence confirmation technology, comprehensive mRNA analysis and detection solutions

2. Comprehensive mRNA sequence coverage, one sequencing can cover 5'UTR, CDS, 3'UTR and Poly(A) tail.

3. High accuracy, using the gold standard Sanger sequencing method

4. Convenient and fast, as fast as 2-3 working days

5. Compatible protocols, detection with or without poly(A), complete lab records and lab reports, support for drug reporting

For details of related services, you can send an e-mail toorder@gentlegen.com or call.0512-6799 8818 ext. 8888.