Methods and Analysis of Biological Contaminants in the Biomanufacturing Industry

The advent of bioprocessing has revolutionized the biomanufacturing industry, leading to rise biotherapeutics derived from biologic products such as chimeric antigen receptor (CAR) T-cells used for targeted cancer treatment and Vero cell line production viral vectors vaccines. Despite these promising developments, most are characterized by fragile macromolecular structures that heterogenous with a purity profile varies each batch making them susceptible microorganism contamination. Regulatory oversight is imperative ensure adherence good manufacturing practices compliance quality management systems. Current assurance protocols during include monoclonality development, real-time monitoring process parameters, flow cytometry microbial monitoring, polymerase chain reaction, immunoassay techniques amplify DNA sequences related bacterial or biological contaminants. FDA guidance recommends implementation analytical technology within measure critical which includes screening potential Future advancements in bioprocess control should capitalize on providing cheap, real-time, sensitive detection. Biosensors, mass spectrometry, reaction present robust, rapid, capabilities multiplexed detection contaminant analytes have shown promise meeting needs. This review discusses main contaminants bioprocesses, European Union regulatory guidelines biologics production, existing methods their limitations, future contamination