Cell Therapy Manufacturing
The Guide to Gene Therapy and Cell Therapy Solutions
What Is Cell Therapy Manufacturing?
Cell therapy manufacturing is the process of turning cells into therapeutic agents through a number of bioprocessing steps that starts from collecting cells from a patient and ends with the administration or infusion of the final cell therapy product (CTP) to the patient.
Cell Collection & Cryopreservation
Cell therapy manufacturing starts with the isolation of specific cells like stem cells, cancer-killing T-cells or natural killer (NK) cells. Cryopreservation at temperatures below −130°C is a key enabling technology that provides stable and secure cell storage.
Cell Reprogramming & Genetic Modification
At the heart of cell therapy manufacturing is cell reprogramming. Cells are genetically modified to increase their immune potency to kill disease-causing cells or to target a specific type of cancer by adding a certain receptor.
What are the steps in cell therapy manufacturing?
Cell Selection & Modification
Cell therapy manufacturing begins with the collection of cells from the patient which often takes place in a clinical or apheresis facility. Specific cells are isolated to collect the needed components and then modified in order to target a specific type of cancer or other disease.
Cells are then cultured and transferred into a growth medium in order to generate enough cells for a single dose in an autologous therapy or hundreds of doses in an allogeneic therapy.
The cells are placed in an incubator where they continue to divide and grow in number which can take multiple weeks.
Cell Harvest, Formulation, Fill & Finish
The cultured cells are washed, harvested, concentrated, and then formulated into the final therapeutic dose.
Packaging, Shipping & Cryopreservation
The cell therapy products are transferred into vials and bags to begin preparation for delivery to the clinical setting.
The cell therapy products are then placed in a controlled-rate freezer (CRF) or cryobank for preservation without damaging the cells or placed in a cryo-shipper for delivery to the clinical setting.