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Vaccine

Attenuated, Inactive, Subunit Vaccine

Vaccines provide active acquired immunity to diseases. Since vaccines are directly given to healthy populations, R&D and production of vaccines demand extremely stringent biosafety requirements. A closed-loop quality control system spanning the entire workflow- from raw material control and process monitoring to product release- must be established to comprehensively reduce biosafety risks.

Biosafety Strategy for Cell and Gene Therapy

Vaccine

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

According to the general requirements of ICHQ5B, ICHQ5D, WHO TRS814 on recombinant products, as well as the relevant requirements of Chinese Pharmacopoeia, European Pharmacopoeia and US pharmacopoeia, the microbial production system should be fully characterized of master microbial bank, working microbial bank and end of production cells.

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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