The manufacturing processes and analytical methods for engineered T-cell therapies (e.g. CAR-T) and autologous ex vivo gene therapies are complex. Cells are first collected from patients via apheresis, modified ex vivo with lentiviral vector (LVV) or other gene addition/gene editing methods, expanded in culture, and frozen as a living drug product. With the rapid growth of the cell and gene therapy field, the demand for LVV has increased exponentially. Current LVV production methods using transient transfection are robust but will ultimately be constrained volumetrically and temporally. To overcome these constraints, alternative production processes may be required to meet future demand. Autologous drug products present a tremendous opportunity for understanding critical quality attributes (CQAs), by correlation of drug product attributes with clinical results and via advanced cell characterization. Although most commercial manufacturers utilize a centralized manufacturing approach, there is a lot of interest in advancing manufacturing beyond decentralized manufacturing to point-of-care or even bedside manufacturing. This presentation will provide an overview of the analytical and process development challenges for cell and gene therapy and opportunities for advancing the technologies to enable these therapies to reach all patients who can benefit from them.

Analytical and process development challenges and opportunities in cell and gene therapy

Macromolecular Chemistry: The Second Century

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ACS Spring 2020 National Meeting & Expo

The official archive and repository for all ACS Meetings & Expositions abstracts and select posters or presentations.