Gene therapies are the red-hot growth areas in pharmaceuticals today. The Levitronix® LFS Single Use flowmeter is an essential component in VERDOT Ips2 systems supporting this industry. Manufacturing Adeno-Associated Virus (AAV) and other gene therapies requires multiple purification and concentration steps to remove host-cell proteins, nucleic acid, and other contaminants.
Low Pressure Liquid Chromatography (LPLC) is established as the effective, reproducible, and robust solution while preserving the efficacy of the vaccine particles. Like antibody-based therapies, LPLC applications must also meet stringent regulatory standards, including traceability of components, prevention of cross-contamination between batches, and cleanliness. Unlike antibody-based therapies, gene therapies are effective at much smaller doses, so their manufacturing processes are done at much smaller scale. With the exponential growth in the number of promising gene therapies targeting critically ill patients, multi-product manufacturing plants become essential. The prevailing industry trends are towards smaller-scale, multi-product capable manufacturing technology solutions.
The FlexiPro Single-Use Chromatography system by VERDOT Ips² allows users to quickly adapt manufacturing scale from very small (8 ml columns running 10 ml/min) to very large (60 liter columns running 600 liters/hour). Product integrity is maintained in a fully-disposable, cleanable flow path.
The presentation explains how VERDOT leverages the excellent dynamic range of the Levitronix® LFS Single-Use flowmeter to precisely control flow, increase system reliability, and minimize product change-over time.