From research to clinical application, a successful & reproducible continuum process for lentiviral vector manufacturing
Gene and cell therapies have emerged as a viable medical and commercial modality for treating not only genetic diseases but also cancers. As such, Flash Therapeutics, a French biotech company, is positioned as a global CDMO expert in the manufacturing of lentiviral vectors used for gene addition or gene editing therapeutic approaches. Our proprietary lentiviral platform includes both regular integrative lentiviral vectors (iLV) and our proprietary non-integrative LentiFlash® technology. Through a continuum from research to clinic, we offer high quality vector manufacturing and personalized support.
Our patented production and purification process guarantees the same specifications from R&D to GMP grade, thus ensuring the success of your clinical study. Our successful and reproducible continuum includes 4 bio-production steps from small scale research to large scale GMP. These stages are supported by regulatory documentation based on quality controls, equipment qualification and certificates of analysis. Each of these stages is punctuated by regular meetings with the scientific team, global account manager and project manager.
Since 2005, Flash Therapeutics has produced more than 9,000 custom batches including 50 large scale (30 to 200mL at about 1E9 IG/mL). A detailed analytical characterization of product titer, process impurities & quality attributes was established, showing the removal of 99% of proteins and DNA impurities. The methodology allows an efficient gene transfer even into delicate or hard-to-transduce cells, while preserving the viability and phenotypic profile of transduced cells.
Combining know-how and high-tech processes, Flash Therapeutics provides small, medium and large-scale production of high-quality lentiviral vectors with the same attribute specifications throughout the process from small scale R&D grade to large scale GMP grade.
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Lucille Lamouroux, PhD Project Manager Flash Therapeutics expert since 2012 |