What Is Cell Therapy Manufacturing?

Cell therapy manufacturing involves several complex steps that require specialized training, equipment and quality measures to manage risk in order to ensure the safety, efficacy, and consistency of the final product.  A cell therapy process differs from biologics manufacturing in that it leverages living cells that can be used to treat a variety of diseases and conditions.

A cell therapy process involves taking cells from a patient or donor, growing them in a lab or GMP manufacturing facility, and then re-introducing them back into the patient's body to repair or replace damaged tissue.

Autologous vs Allogenic Cell Therapy

There are two general types of cell therapy processes: autologous and allogenic.  The difference between these processes depend on the origin of the cells.

Autologous Cell Therapy Manufacturing

An autologous cell therapy process uses a patient's own cells for treatment. These cells are collected from the patient's body, processed in a lab or manufacturing production facility, and then reintroduced into the patient's body.

Allogenic Cell Therapy Manufacturing

An allogenic cell therapy process involves using cells from a donor for treatment. These cells are harvested from a healthy donor, processed in a lab, and then introduced into the patient's body.

Common Steps in a Cell Therapy Manufacturing Process

While the specifics of cell therapy manufacturing can vary depending on the type of therapy being produced, there are some common steps that are typically involved in the cell therapy manufacturing process.

These steps include:

Cell Sourcing

The first step in the process is obtaining the cells that will be used for the therapy. This may involve harvesting cells from a patient's body or obtaining cells from a donor.

Isolation and Selection

Cell selection or isolation is the process of identifying and separating specific cells from a larger population for use in cell therapy manufacturing. This may involve using specific markers or other characteristics to identify the desired cells, and then separating them from other cells in the population using techniques such as fluorescence-activated cell sorting (FACS) or magnetic-activated cell sorting (MACS).

Activation

Activation is the process of stimulating cells to become more active or responsive. In cell therapy manufacturing, activation may be used to enhance the therapeutic properties of the cells, such as increasing their ability to target specific tissues or improving their ability to migrate to damaged areas of the body.

Gene Transfer

The gene transfer step introduces genetic material into cells using a viral vector. This technique is used in cell therapy manufacturing to modify cells in a way that enhances their therapeutic properties. The viral vector is engineered to carry the desired genetic material, which is then introduced into the cells. Once the genetic material has been introduced, the newly modified cell population is expanded.

Cell expansion

Cell expansion in cell therapy manufacturing is very similar to small scale bioreactor operations in biologics processes.  Expansion is the process of creating an environment in which the cells can grow and multiply. This involves providing the cells with the necessary nutrients and growth factors to encourage their growth, as well as controlling the environment to ensure that the cells remain healthy and functional. 

Harvest and Formulation

After the cell expansion step is completed, the cells are usually collected from the bioreactor and then formulated. Formulation prepares the cells for use in the patient's body. This may involve washing the cells to remove any impurities, exchanging fluids and adjusting the cell concentration to ensure that they are at the appropriate dosage level. Once the cells have been formulated and are at the right dosage they are ready to be reintroduced into the patient's body to treat the disease or condition but first they must be filled into sterile containers and cryopreserved.

Aseptic Fill

Aseptic fill is the process of filling a sterile product into a sterile container in a way that maintains the sterility of both the product and the container. This process is used in cell therapy manufacturing to ensure that the final product is free of contaminants that could compromise its safety or efficacy. Aseptic fill typically involves the use of specialized equipment and facilities to maintain a sterile environment, as well as rigorous quality control measures to ensure that the final product meets the required standards.

Cryopreservation

Cryopreservation is the process of freezing cells at very low temperatures, typically -80°C or lower, in order to preserve them for future use. Cryopreservation is an important technique in cell therapy manufacturing, as it allows for the storage of large quantities of cells that can be used for future treatments. The freezing process can damage cells, so special techniques and solutions are used to minimize this damage. Once the cells are frozen, they can be stored for long periods of time and then thawed and used when needed.

Cell therapy involves using living cells, such as stem cells or immune cells, to treat diseases or repair damaged tissues. The process of manufacturing cell therapies involves several complex steps and requires adherence to strict quality control measures to ensure the safety, efficacy, and consistency of the final product.