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 it also proved difficult to scale up and posed great challenges to safety assurance, specifically in the form of exogenous factors. This method also has high requirements for material, production process, and cost control. To address these challenges, the switch to suspension production of viral vectors was an inevitable change. Our senior experts and technical team at Porton Advanced have developed a proprietary suspension serum-free production platform called LV-SMART®, which adheres to relevant regulations and builds off our experience in virology, bioprocessing, and quality control.
Our LV-SMART® platform simplifies the production process for fast project delivery. Porton Advanced’s proprietary HEK293T cell line enables a high virus titer and is easy to scale up without animal-derived components as raw materials. Additionally, we have developed a unique purification technology with high recovery rates, low residues, and a high infectious titer. With this innovative and well-established platform, it takes us only 7 months to go from microbial banking to the first cell product primary batch delivery.
Ready-to-use Cell Bank with Registered FDA DMF Files
The HEK293T cell line used in our LV-SMART® platform was developed through clonal screening and suspension adaptation. It has clear traceability and full records of 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).
The LV-SMART® Platform has been used for different Lentiviral vectors' envelopes with different GOIs projects.
The crude titer for lentiviral vectors pseudotyped with VSV-G, BAEV, and Cocal and with different GOIs is over 5E07TU/mL.
