Fig. 4

Select patients who will respond to treatment with universal CAR-modified cells or a particular CAR product. To select responders for a particular CAR treatment, tumor cells or plasma can be isolated from 8 ml of peripheral blood from each patient. CAR cell IS quality can be assessed by lipid bilayer and VCP device. Briefly, blood is collected into a 10 ml tube with anticoagulant as a regular specimen collection procedure. The tube can be sent directly to the synapse testing lab without transferring to a secondary tube. PBMCs, plasma, and tumor cells can be enriched. Plasma can be used later for mimicking the tumor microenvironment by adding the patient’s plasma to the imaging system on both the lipid bilayer system and VCP system. Meanwhile, the enriched PBMCs are placed in culture and expanded. The viral vector containing the universal CAR construct such as CD19-CAR, is added to generate CAR products. These universal CAR products are subjected to IS quality testing. Both the lipid bilayer chip and VCP device can be used to evaluate the IS quality of universal CAR products in response to tumor cells isolated from each individual patient. IS quality ranking reports can be presented to physicians who will base their decision of which CAR product to prescribe. The informed physicians can select a particular patient (responder) for a particular CAR treatment or clinical trial. Meanwhile, for non-responders, IS testing can identify another suitable CAR therapy. The manufacturing company generates the prescribed CAR for this patient with proper quality control release testing and quality assurance review. The final product is cryopreserved and delivered to infusion sites, where the CAR T medicine is infused