Building a LVV characterization and process validation strategy

Burnham, Michael

doi:10.18609/cgti.2019.056

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2021

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“…The need to urgently implement more precise control systems, mainly in USP phases, has recently become a topic of discussion within the industry [34,35]. Biomanufacturers are shifting from "Quality by Testing" where product quality is assessed at the end of the process, to "Quality by Control," where product quality is monitored and adjusted during the process [36].…”

Section: Analyticsmentioning

confidence: 99%

Lentiviral vectors: key challenges and new developments

Elizalde¹,

Ramı́rez²

2021

Cell Gene Therapy Insights

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Gene therapy is no longer an experimental approach. We are now witnessing the advent of genes as medicinal products, based on stable expression of therapeutic genes. Laboratoryborne viruses, also known as viral vectors, can efficiently deliver genes to the cells they infect, with lentiviral vectors (LVVs) one of the most widely used. This article will review existing lentivirus-manufacturing technologies and how they need to be adapted to meet the current market demand, from the perspective of VIVEbiotech -a CDMO manufacturing LVVs to EMA and FDA standards for use in clinical trials.

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Section: Analyticsmentioning

confidence: 99%