Laboratory automation and miniaturization to overcome the challenges of quality control in lentiviral vectors

Advanced Therapy Medicinal Product (ATMPs) has been positioned as the most promising pharmaceutical tool to cure an endless number of diseases such as Alzheimer´s, cancer and rare diseases that currently have no effective treatment. The manufacturing and the quality control (QC) of these novel products presents challenges due to the complexity of the analytical assays, online monitoring, and the need of rapid batches release to meet with the expected timeline of the treatment.
Laboratory automation and digitalization are advancing faster than ever before and can now support the process development and characterization of advanced therapies. Indeed, automation and digitalization can increase the facility throughput and make QC faster, more agile, more compliant, and more efficient by reducing manual errors and variability, as well as allowing faster and effective resolution of problems in the process development.
VIVEBIOTECH, as CDMO of gene therapy products, is integrating new technologies and automation to improve the analytical characterization and the release of the lentiviral product. VIVEBIOTECH is integrating liquid handlers (Biomek i5) and microfluidic technology (Gyros® platform) to automate and miniaturize both purity and potency assays critical aspects for product release. Here, we present some case studies of how these technologies have improved the quality, the efficiency, and the reliability of the analytical results for functional and physical lentiviral titter.