Advances in LV EdgeProducer technology, a synthetic biology company that designs and manufactures therapeutics, have achieved unconcentrated titers of 1E9 transducing units/mL (TU/mL) for therapeutic transgenes. According to Asimov, LV Edge Producer's technology eliminates his GMP plasmids, lowering costs and reducing risk of fluctuations in his supply chain and products.
“The LV Edge Producer System achieved unconcentrated lentiviral titers of E9 TU/mL against a clinically relevant chimeric antigen receptor (CAR) transgene,” said Asimov CEO Alec Nielsen. Ta. Bioprocess Insider.
“This system integrates viral genes into host cell lines, reducing the cost and variability associated with complex transient processes. It will be completed within the next few days and will be conducted in Boston. [Massachusetts, US], Cell Line Development Facility. The 1E9 TU/mL title is 10 times higher than comparable transient-based processes. The stepwise increase in titer allows for low-cost production of lentiviruses, allowing their application in larger therapeutic indications. ”
According to the company, when a customer requests a cell line development campaign, the sequence of the gene of interest (GOI) is first transferred. Asimov then uses its design software to optimize the sequences to improve functional titers and generate stable pools by simultaneously transfecting his four plasmids containing viral genes.
The pool is then cloned using equipment that allows verification of monoclonality and screening methods to enrich for high-performing clones. These clones will be shipped to the customer or his preferred GMP manufacturing partner within 4 months after transfection as a research cell bank.
The company says the system does not have limitations based on large-scale transfection, allowing it to be applied to larger disease indications.
“This system simplifies the manufacturing process by eliminating complex transient transfection protocols and reducing supply chain risks associated with GMP plasmids. This approach ensures uninterrupted production. “In addition, speed to market is maintained without compromising manufacturing efficiency. Additionally, batch-to-batch variation is minimized, ensuring more reliable and predictable results.” says Mr.
