This document describes the process for manufacturing and delivering NexCAR19, a CAR T-cell therapy. The process involves:
1. Extracting a patient's white blood cells through leukapheresis at the hospital.
2. Shipping the extracted cells to the manufacturing site for selection, activation, and genetic modification of T-cells to target B-cell cancer.
3. Testing and cryopreserving the manufactured product before shipping back to the hospital within 9-19 days for intravenous infusion into the patient.
This document describes the process for manufacturing and delivering NexCAR19, a CAR T-cell therapy. The process involves:
1. Extracting a patient's white blood cells through leukapheresis at the hospital.
2. Shipping the extracted cells to the manufacturing site for selection, activation, and genetic modification of T-cells to target B-cell cancer.
3. Testing and cryopreserving the manufactured product before shipping back to the hospital within 9-19 days for intravenous infusion into the patient.
This document describes the process for manufacturing and delivering NexCAR19, a CAR T-cell therapy. The process involves:
1. Extracting a patient's white blood cells through leukapheresis at the hospital.
2. Shipping the extracted cells to the manufacturing site for selection, activation, and genetic modification of T-cells to target B-cell cancer.
3. Testing and cryopreserving the manufactured product before shipping back to the hospital within 9-19 days for intravenous infusion into the patient.
NexCAR19 Actalycabtagene autoleucel From Vein-to-Vein
Hospital Manufacturing Site
Patient consent & enrollment
Day 0 Shipping Day 1 - Day 9
Leukapheresis (The Leukopak is shipped Manufacturing (White Blood Cells to ImmunoACT’s (ImmunoACT’s scientists select and activate the T-cells, then modify them using a safe are extracted by a manufacturing facility lentiviral vector. This makes the T-cells express special connectors, called Chimeric Antigen machine at the under refrigerated Receptors (CARs) that target your B-cell cancer. The cells are then cultured and expanded Hospital, in a conditions) until they reach a target dose) Leukopak)
Product Quality Formulation and
Assurance Cryopreservation
Infusion Day 9-19
(The Product is administered via Shipping intravenous infusion. Prior to this, (The Product is shipped in (The Product is cryopreserved, and the patient is given a conditioning an Infusion bag under undergoes extensive testing to ensure its chemotherapy to ready their body cryopreserved conditions to Identity, Purity, Safety, & Potency) for the treatment) the hospital)