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Nuclear Acid Drug

mRNA, siRNA, etc

As a novel class of pharmaceuticals, nucleic acid drugs use DNA/RNA as active ingredients. However, they present unique biosafety challenges: molecular instability, delivery risks, and manufacturing variability. To ensure safety, a comprehensive quality control system spanning raw materials to final products must be implemented using advanced analytical technologies.

Biosafety Strategy for Nucleic Acid Drug

Nuclear Acid Drug

Microbial Bank Characterization

E. coli and its plasmids play an important role in biopharmaceuticals, which are used in the research, development and production of different biological modalities to meet the requirement of large-scale clinical applications.

Biosafety Consideration of Plasmid Process

Purityof Microbial Bank
Plasmid Retention Ratein HostStra
Antibiotic Residual Testing
Lysis Efficiency of Bacteria
Endotoxin Residual
Plasmid Construction
Genetic Stability of E.coli
Bacteriophage Contamination
......

Regulatory Requirement

All viral seed stock shall be characterized according to the requirements of European Pharmacopoeia 2.6.16 and FDA2010 Guidelines for the management and quality control of bacterial/viral seed banks. Regulations require the use of neutralizing antiserum for post-neutralization tests.

BRC Solutions for Microbial Bank Characterization

BRC Bio offers quality testing for E. coli and plasmid products, meeting the requirement of gene therapy, gene-modified cell therapy, vaccine, nuclear acid drug etc.

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