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Cell Therapy Manufacturing

Cell and gene therapy (CGT) manufacturing is a fast-growing field that offers new hope for the treatment of diseases. Choosing the right monitoring system is critical to ensuring the successful delivery of life-saving therapies.
a row of small test tubes on a rack

The Guide to Gene Therapy and Cell Therapy Solutions

Cell and gene therapies are innovative solutions that offer huge potential for preventing and treating many diseases and disorders based on genes, tissues, or cells. Get ahead of the evolving requirements of cell and gene therapy manufacturing, research, development.
a pipette dropping a red solution into test tubes

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.

a plate containing different cell cultures

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.

an abstract image of a test tube with a large dna strand in the center of it

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?

a lab technician using a microscope with red blood cells animated on the left of the image

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.

a lab worker placing a tray in a compartment

Cell Culture

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.

a pipette extracting solution from Petri dishes

Cell Harvest, Formulation, Fill & Finish

The cultured cells are washed, harvested, concentrated, and then formulated into the final therapeutic dose.

assorted trays containing clear solutions

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.