LV-SMART™ LVVs Suspension Production Platform

In the early stages of viral vector preparation, adherent cells containing bovine serum were most commonly used for production. However, not only were the costs high, but this also proved difficult to scale up and posed great challenges to safety assurance, specifically exogenous factors. This method set higher requirements for material control, production process control, and cost control. To solve those issues, the suspension production of viral vectors was an inevitable change. The senior experts and technical team at Porton Advanced have developed a proprietary suspension serum-free production platform called LV-SMART™, which is based on relevant regulations and our rich experience accumulated in virology, bioprocesses, and quality over the years.

Porton Advanced’s proprietary HEK293TG2S cell line enables a high virus titer and is easy to scale up. We have also developed a unique purification technology that has high recovery rates, low residues, and high infectious titer. Our platform is in compliance with industry standards, and PCT patent application has been submitted.

The HEK293TG2S cell line used in our LV-SMART™ platform was developed through clonal screening and suspension adaptation. It has clear traceability and complete records of the cell line development, cell recovery, and passage. The cell line established two-tiered cell banks (master cell bank and work cell bank), which are both applicable for IND application in the US and China. The master files for MCB and WCB have been received by the Center for Biologics Evaluation and Research (CBER).

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The MASTER FILE
ACKNOWLEGEMENT is as follows: