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Cell and Gene Therapy

Viral Vector, Oncolytic Virus, Stem Cell, CAR-T/TCR-T, CAR-NK, TIL, etc

Cell and gene therapies (CGT) are advanced biological products including viral vectors, oncolytic viruses, stem cells, CAR-T/TCR-T, CAR-NK, and tumor-infiltrating lymphocytes (TILs). Due to their unique mode of action (MOA), the manufacturing processes of these emerging biologics are more complex compared to traditional biologics and small molecule therapeutics. They require stringent GMP controls while experiencing rapid market growth. To ensure final product quality, developing science-driven, process-informed biosafety testing strategies that meet global regulatory standards is essential.

Biosafety Strategy for Cell and Gene Therapy

Cell and Gene Therapy

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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