Discussion of cell therapy from the point of standardization, scale and industrialization

What is cell therapy?

Cell therapy refers to the transplantation or entry of normal or bioengineered human cells into a patient’s body and newly imported cells can replace damaged cells or involve a stronger immune-killing function, to achieve the purpose of treating diseases. Cell therapy has shown greater application value in the treatment of cancer, hematological diseases, cardiovascular diseases, diabetes, Alzheimer’s disease, etc. Generally, cell therapy includes tumor cell immunotherapy and stem cell therapy. There are two sources of cells for cell therapy, one from the patient himself and the other from allogeneic tissue.

The defects of cell therapy

The cell is the most basic unit that contributes to a living organism, however, it does not mean that everyone shares the same cells. On the contrary, there is a great difference in each individual that can be compared with the differences between humans, that is, there are never two identical people. The big difference between cells and cell preparations is the biggest drawback of cell therapy. In this post, we will discuss various topics that need attention in the current stage of cell therapy.

Difficulties in standardizing cell therapy

Cancer cell immunotherapy cannot be standardized from the raw material acquisition stage. The cell treatment material for each patient is their own blood leukocytes. The condition and physical condition of each patient is different, and the amount of white blood cell growth collected and the killing activity are not uniform and cannot be standardized. As it is impossible to standardize raw materials, preparation processes and product specifications, it cannot be standardized, industrialized and expanded. Every tumor cell immunotherapy laboratory complies with the GMP level with the hardware environment, and it can be more like a cell preparation workshop. The researchers ranged in number from a few to a dozen and couldn’t really meet the division of labor standards of industrialized pharmaceutical companies. Taking as an example stem cell therapy using mesenchymal stem cells from the umbilical cord, the raw material of which is an umbilical cord, and a cell produced by the umbilical cord, many patients can use it. The way of standardization is more advanced than tumor cell immunotherapy, and the raw materials can be standardized to some extent.

Difficulties on the scale of the cell therapy industry

At present, the mode of production of the cell therapy industry depends mainly on technicians. In the 10,000 grade clean lab, cells are run on a class 100 clean bench, grown in a carbon dioxide incubator, spun in a centrifuge, viewed through an inverted microscope, and drug reagents are stored in a medicine refrigerator. All these devices are operated by biological laboratories independent of the individual and are interconnected through the operations of scientists. This type of production model is small-scale and similar to workshop-type production. Although there are some large scales, the essence is a collection of many small workshops. Due to the small scale, the instruments used are laboratory instruments and many of the reagents used are scientific reagents, which will lead to the problem of low efficiency but high cost.

Autologous or allogeneic

There are two types of cell sources for cell therapy, one from patients and one from allogeneic tissue. Autologous cell therapy cannot be standardized from the raw material acquisition stage, and is only applied to the patient himself, the essence is essentially medical technology. The prevalence of autologous cell therapy as a medical technology is mainly due to the magnitude of the situation. Allogeneic therapy, cells derived from allogeneic. Taking tumor cell immunotherapy as an example, the cell source can be from umbilical cord blood and the larger scale cell source can be a filter plate for leukocyte filtration in the blood bank. Taking the mesenchymal stem of the umbilical cord as an example, the cell source is the umbilical cord and an umbilical cord producing cell can be used by more than one person. If flakes can be grown, although quality standards cannot be well quantified, the scaled products themselves have a certain degree of standardized properties.

The cellular industry, as an industry, is not the path to advancing cell-based therapeutics. If advanced technology cannot be mass-produced on a large scale, it can only remain in the laboratory and become an object of research for scientists, it will never have a chance to become a drug for most patients. For allogeneic cell therapy using allogeneic cells as raw materials, standardized properties of scaled products can be realized if large-scale cultures are prepared, then scale and standardization can be mutually promoted. Current progress in cell standardization is not easy, but progress on scale should be relatively easy to achieve.

Natural cytokine supernatants with more standardized and standardized properties

Cytokines are a class of small molecule proteins with broad biological activity synthesized and secreted by immune cells (such as monocytes, macrophages, T cells, B cells, NK cells, etc.) and certain non-immune cells (endothelial cells, epidermal cells, etc.). fibroblasts, etc.) Immune responses are regulated by binding to the respective receptors to regulate cell growth, differentiation, and effects. Cytokines (CKs) are low molecular weight soluble proteins that are produced by various cell types induced by immunogens, mitogens, or other stimulants. They have the ability to regulate innate immunity. [1] and adaptive immunity [2], hematopoiesis, cell growth and repair of damaged tissues and other functions.

Cytokines can be divided into interleukins, interferons, tumor necrosis factor superfamily, colony stimulating factors, chemokines, growth factors, etc. Cytokines form a highly complex cytokine regulatory network in the body and are involved in many important physiological functions in the human body. Where stem cells and immune cells cannot reach the body, cytokines can easily reach target tissue sites due to their small size.

In recent years, recombinant gene cytokines have made remarkable achievements in clinical applications as a new modifier of biological response. A large part of the effects of stem cell therapy and immunotherapy arises from the action of cytokines secreted in the body. Stem cells and immune cells from the body are reintroduced into the body to secrete a variety of natural structural cytokines. Although the amount of these cytokines is relatively small, they are synergistic and act directly on the cytokine network in the body due to their high naturally-occurring structure activity, lack of antigenicity but diversity. Due to the standardization, standardization, industrialization, and scaling of natural compound cytokines, it is more cost-effective than cell therapy, allowing more needy patients to enjoy cell-like therapeutic effects.

Although natural complex cytokines can largely replace cell therapy, there are still conditions that require the presence of cells to exert a therapeutic effect. We hope that cell therapy can break out of the current situation, become high-efficiency and low-cost with a large scale, more standardization, and then be applied to more disease treatments.

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