Automated, Scalable, And GMP-Compliant MSC Cell Therapy And EV Manufacturing Using Lonza TheraPEAK® MSC-VIVO™

By Iva Klevernic2, Nyiah Jordan1, Ilaria Passalacqua2, Giulio Nanni2, Dammar Thapa2, Marthe Quintens2, Ingrid Vernooij2, Shannon Noble2, and Pascal Yazbeck1 (1 Lonza Bioscience, Specialized Modalities R&D; 2 Lonza Specialized Modalities CGT Development Services)

Many mesenchymal stromal cell (MSC) processes still rely on 2D culture and supplements such as fetal bovine serum (FBS) or human platelet lysate, which raise regulatory concerns and are incompatible with extracellular vesicle (EV) manufacturing. Establishing scalable, GMP-compliant 3D production processes therefore remains a challenge as interest in cell-free, EV-based products grows.

This white paper from scientists at Lonza Bioscience and Lonza CGT Development Services, including Iva Klevernic, Nyiah Jordan, and Pascal Yazbeck, investigates a xeno-free medium across multiple stages of MSC culture and scale-up. The work follows bone marrow-, adipose-, and umbilical cord-derived MSCs from 2D culture through spinner flasks to automated 3D runs at volumes of up to 1.4 L. The study compares performance in a stirred-tank vessel and the 3D Scalable Automated Bioreactor, examining EV integrity, tetraspanin expression, and functional potency using a wound healing assay. These assessments provide a basis for evaluating how the two bioreactor formats perform under the conditions tested.

Explore the data for a side-by-side comparison of the results and their relevance to developing scalable MSC-derived EV manufacturing processes.