LVV Development And Manufacturing: The Beauty Of An Established Platform Process

Developing a cell therapy product is incredibly complex. Speed to clinic and market is imperative to reduce overall costs and maintain competitive market advantages. Leveraging an established lentiviral vector (LVV) process accelerates drug product development. The LVV platform from Miltenyi Bioindustry provides turnkey solutions for scalable preclinical batches, validated release assays, a fast track to GMP manufacturing, and regulatory support.

After establishing clinical efficacy, the LVV platform will continue to provide value as the product development lifecycle enters process characterization and validation activities. Guided by the site validation plan and process validation master plan, the sponsor’s quality target product profile will be weighed against platform risk assessments. For unit operations in need of characterization, established small-scale models and in-process analytics will be used for design-of-experiment studies, which will ultimately drive the process control strategy.

Altogether, the beauty of an established LVV platform is that it is focused on the development of technical prerequisites and infrastructure in favor of executing key activities in the context of the sponsor’s LVV.