Cell therapy initiated its journey in the USA and Europe with Autologous chemical antigen receptors like T-Cell therapies like Yescarta and Kymerah. Thereafter the treatment traveled through different tests and trials to reach clinical perfection.
The worldwide study of CAR T-cell therapies has also increased, and they open doors for the development of other therapies. Cell therapies using stem cells are a new hope for patients. Therefore, stakeholders like researchers, clinical laboratory companies, and the government invest their resources to broaden research opportunities and bring out innovative strategies and technologies.
The ultimate aim in bringing in an evolution of cell therapy is to broaden or diversify its utilization (for example, in the treatment of Alziermers. The article discusses Cell Therapy Manufacturing and things to consider for successful cell therapy manufacturing.
What Is Cell Therapy Manufacturing?
Cell therapy manufacturing includes the collection of stem cells from the patient. This takes place in a technically equipped clinical facility. It covers different steps and ends with the administration of drugs to the patient.
What Are The Things To Consider With Cell Therapy Manufacturing?
The point between a collection of cells to the final manufacturing faces numerous challenges for the manufacturing teams. Though there are diverse challenges, they are mainly concentrated in the supply chain and the manufacturing and administration phases.
Acquiring comprehensive knowledge of the technicalities, technologies, risks, and others requires thorough engagement and reciprocation of ideas. Therefore, therapy professionals can use platforms and be a part of the vibrant community and discuss the various aspects of autologous cell therapy. This section discusses some of the factors in cell therapy manufacturing.
Cell therapy is represented by Allogeneic bone marrow, that is, the collection of healthy cells from the bone marrow. It needs to be done under a well-equipped medical setup. The use of plastic flasks for the culture is a must. This is because the MSCs (isolated from the 10 ml of the bone marrow ) can grow under the plastic flaxes.
At this point, it is important to note that the MSCs constitute 0.01% of the bone marrow white blood cells. Therefore they have to be cultured.While selecting these plastic components, the manufacturers must consider animal product-free materials. They must meet the USP VI requirement.
2. Safety And Sterility
Safety and sterility are important factors to consider in cell therapy manufacturing, and there are some serious reasons behind them. The materials used in collecting the stem cells from the bone marrow to that of the other process before manufacturing introduces contamination as it moves to the final stage of CTP.
Therefore it becomes a must for the experts to sterilize the containers and equipment used in the process. Sterilization alleviates impurities and increases the safety of the final CTP.
Another aspect that clinical experts must consider in Cell Therapy manufacturing is the safety measure. They are a must for single used components used in clinical trials.
The manufacturers must consider the expiration dates provided by the equipment manufacturer. They must abide by the integrity and the manufacturing protocols to ensure utmost safety.
The equipment used in the collection, processing, culture, manufacturing, and injecting back of healthy stem cells should not introduce particulate matter. This particulate matter may affect the final product.
Hence steps have to be taken so that the removal of the sub-visible particles is done through filtration. This is a challenge, and new technologies are being developed so that it meets the standards and expectations.
Cell therapy manufacturers are working to identify the particulates that might compromise the quality of CTP.
They are also trying to identify the particles that make their way into the equipment. They are also working on implementing control in their manufacturing process to avoid the risks of contamination of particles.
The points that are discussed in this article are major factors that cell therapy manufacturers consider in cell therapy manufacturing.
Apart from them, some others are related to the clinical procedure, including Extractable and Leachables, Toxicity of the chemical sterilants, and performance equipment are also important. All these factors open new routes towards stronger protocols and better results.