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Also known as cellular therapy or cryotherapy, cell therapy is any technique in which viable cells are introduced into a patient’s body through injection, grafting, or implantation to produce a medicinal outcome. Good examples include the transplanting of T-cells with the capability to fight cancer cells during immunotherapy or grafting stem cells to help regenerate damaged tissue. Bone marrow transplantation is also a form of cell therapy.

Types of cell therapy

In allogeneic cell therapy, patients are treated with cells derived from other donors. Scale-up for allogeneic therapies is important, as these are typically intended to treat many people.

Autologous cell therapies are made from a patient’s own cells. Because this type of therapy is patient-specific, large-scale manufacturing of one cell line is unlikely. Instead, autologous therapy manufacturing should accommodate scaling out production, for example with many smaller bioreactors. Chimeric antigen receptor (CAR) T cell therapy, in which a patient’s T cells are engineered to attack cancer cells, is an example of an autologous therapy.

Cell therapy manufacturing workflows

The major steps of cell therapy manufacturing include isolation of cells from tissue or blood, gene transfer (for genetically engineered cells such as CAR-T), expansion of cells, harvest and formulation of cell therapy, cryopreservation for storage or transport, and administration of therapies at point of care. We offer a range of cell therapy solutions for research, process development, and scale-up or scale-out.

Cell therapy processes

The commercialization of cell therapies calls for optimization at all stages, including process development, cell processing, testing, and manufacturing. Considerations during cell therapy manufacturing include:

  • Media and reagent preparation: Expansion and processing media, reagents, and supplements should be validated for each application and type of expansion. Consider the set-up requirements, product storage, and vendor compatibility.
  • Expansion: The type of cell expansion protocol and system you use depends on the type of cell therapy you’re producing. Cells can be expanded manually or using automated systems like our Xuri™ cell expansion systems.
  • Harvesting and formulation: For efficient and cost-effective large-scale production of cell cultures, high yields are crucial. Functionally closed, automated systems can help improve efficiency and reproducibility in cell therapy harvesting and formulation.
  • Cryopreservation: Management of the supply chain ensures samples remain viable at manufacturing facilities and at hospitals. Combined with quality reagents, cryopreservation helps preserve sample integrity.
  • Process development: Process development and workflow bottlenecks are avoidable with the right planning and support.

We offer cell and gene therapy process development services and training, as well as configurable platforms for cell therapy GMP production.

Cell therapy solutions FAQs

Here are answers to some frequently asked questions about cell therapy solutions.

What is cell therapy?
Cell therapy uses living or viable cells to produce a therapeutic effect. Production and manufacturing of these therapies is a complex process with multiple steps. We offer a range of cell therapy solutions to support reproducibility, consistency, and efficiency in your cell therapy workflows.

What are the applications for cell therapy?
Clinical applications of cell therapy include:

  • Regenerative medicine (e.g., cord blood cell therapies)
  • Hematopoietic and immunologic reconstitution
  • Treatment of cancers such as leukemias or lymphomas