As cell and gene therapies (CGT) transition from scientific promise to clinical and commercial impact, the field faces a new imperative: how do we scale with precision, speed, while reducing cost of goods sold (COGS)? From AAV-based gene therapies to CAR T and stem cell-based treatments, the success of these modalities depends on our ability to deeply understand and guide cellular manufacturing systems in real time.

This keynote will examine the evolving cell and gene therapy (CGT) landscape through the lens of Laser Force Cytology (LFC), a novel label-free technology that quantitatively measures the intrinsic biochemical and biophysical properties of single cells using optical and hydrodynamic forces. By eliminating the need for dyes, antibodies, or genetic reporters, LFC enables non-invasive, real-time analysis of cellular function across the entire therapeutic manufacturing lifecycle.

Beyond descriptive analytics, LFC enables machine learning (ML)-driven predictive and prescriptive analytics, enabling identification of high-quality starting material, real-time potency tracking, and adaptive process control to minimize out-of-trend and out-of-spec batches. We will highlight applications across gene therapy (e.g., AAV transduction efficiency), CAR T manufacturing (e.g., donor characterization and functional prediction), and stem cell therapies (e.g., differentiation monitoring), demonstrating how LFC and ML together unlock new levels of process insight and control.

The convergence of label-free biophysics and ML is now driving a new generation of real-time process analytical technologies (PAT), aligned with regulatory priorities for adaptive manufacturing and quality-by-design. As the CGT field matures, these capabilities will be essential to delivering safe, effective, and scalable advanced therapies to patients worldwide.

Sean Hart

LumaCyte Inc

Appearances