Advancing its LV Edge Producer technology, the synthetic biology company dealing with design and manufacture of therapeutics, has achieved unconcentrated titers with 1E9 transduction units per mL (TU/mL) for therapeutic transgenes. According to Asimov, the LV edge Producer technology eliminates GMP plasmids, which reduces costs and mitigates supply chain and product variability risk.
“LV Edge Producer System achieves E9 TU/mL unconcentrated lentiviral titers for clinically relevant chimeric antigen receptor (CAR) transgenes,” Alec Nielsen, CEO of Asimov told BioProcess Insider.
“The system integrates viral genes into the host cell line, which reduces costs and the variability associated with complex transient processes. The service takes less than six months from sequence transfer to a stable, clonal cell line and is performed in our Boston, [Massachusetts, US], cell line development facility. The 1E9 TU/mL title is 10x higher than comparable transient based processes. A step-change increase in titer enables lower-cost lentivirus production and unlocks applications for larger therapeutic indications.”
According to the firm, when a customer requests a cell line development campaign, they first transfer the sequence of the therapeutic gene of interest (GOI). Then Asimov uses its design software to optimize the sequence to improve functional titer, generating stable pools by simultaneously transfecting the four plasmids containing viral genes.
The pools are then cloned with instrumentation to allow verification of monoclonality, and a screening method to enrich high-performance clones. These clones are shipped as research cell banks to its customers or their preferred GMP manufacturing partner within four months of transfection.
The system does not have the same transfection-based limitations at larger scales, which can unlock applications in larger disease indications, says the firm.
“The system simplifies the manufacturing process by eliminating complex transient transfection protocols and reducing supply chain risks associated with GMP plasmids. This approach not only ensures uninterrupted production but also maintains speed to market without compromising manufacturing efficiency. Additionally, variability between batches is minimized, ensuring more reliable and predictable outcomes,” Nielsen said.
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