Accelerator℠ Integrated Platform Solution for Adherent Lentivirus (LV)
While there is a lot of experience from the field of recombinant antibodies that can be bridged to this evolving industry, manufacturers are facing differences and challenges at various stages of the drug marketing journey, from development and manufacture, to the regulatory approval of LV for in-vitro and in-vivo use.
The global viral vector manufacturing capacity is estimated to be 1–2 orders of magnitude lower than what is needed to support commercial supply requirements both today and in future. Academics and industry are therefore putting focus on measures for the most durable capacity increase; improving manufacturing practices to increase productivity through engineering cell lines, refining plasmid constructs, and enhancing process recovery in downstream processing.
Moving LV products into the highly regulated GMP production environment puts a spotlight on the rising expectations in drug reviews, as the understanding in industry and regulatory bodies is building. The much-needed regulatory framework is rapidly developing and is supported through multiple guidance documents that have been published recently. Part of the challenge to obtain regulatory approval is paired with analytical constraints: viral titer, quality and impurity assays require lengthy off-line processes and come with limited sensitivity.
Learn more about our end-to-end process support, from development to industrialization with a set of scalable solutions for lentivirus production.
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