
The Complete Guide to Know about Cell Therapy from the Point of Standardization - benniebio
https://www.creative-bioarray.com/oncology.htm
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benniebio
What is cell therapy? Cell therapy refers to the transplantation or input 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,
so as to achieve the purpose of treating diseases. Cell therapy has shown
higher application value in the treatment of cancer, hematological diseases,
cardiovascular diseases, diabetes, Alzheimer's disease etc. In general, cell
therapy includes tumor cell immunotherapy and stem cell therapy. There are two
cell sources for cell therapy, one from the patient itself and the other from
the 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 huge difference in each individual which
can be compared to human-to-human differences, that is, two identical people
never exist. The huge difference between cells and cell preparations is the
biggest drawback of cell therapy. In this post, we will discuss several issues
that need attention in the current stage of cell therapy.

Difficulties in the Standardization of Cell Therapy Cancer cell immunotherapy
cannot be standardized from the stage of raw material acquisition. The cell
treatment materiasl for each paitient are their own blood leukocytes. The
condition and physical condition of each patient are different, and the
collected white blood cell growth quantity and kill 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 scaled up. Each tumor cell immunotherapy laboratory meets
the GMP level with the hardware environment, and it can be more like a cell
preparation workshop. Researchers ranged in number from a few to a dozen and
could not really meet the standards of division of labor of industrialized
pharmaceutical companies. Taking stem cell therapy that using umbilical cord
mesenchymal stem cells as an example, which raw material is an umbilical cord,
and one umbilical cord-produced cell can be utilized by many paitients. The
standardization path is more advanced than the immunotherapy of tumor cells,
and the raw materials can be standardized to some extent.

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benniebio
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, fibroblasts, etc.) Immune
responses are regulated by binding to the respective receptors to regulate
cell growth, differentiation and effects. Cytokines (CK) are low-molecular-
weight soluble proteins that are produced by various types of cells induced by
immunogens, mitogens, or other stimulants. They have the ability to regulate
innate immunity [1] and adaptive immunity [2], hematopoiesis, cell growth, and
damage tissue repair and other functions.

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

In recent years, recombinant gene cytokines have made remarkable achievements
in clinical applications as a novel biological response modifier. A large part
of the effects of stem cell therapy and immune cell therapy arises from the
action of cytokines secreted in the body. The stem cells and immune cells in
the body are introduced back 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 because of their high natural structure activity, lack of antigenicity
but diversity. Because of the standardization, standardization,
industrialization, and scale of natural compound cytokines, it is more cost-
effective than cell therapy, allowing more patients in need to enjoy cell-like
therapeutic effects.

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

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benniebio
Difficulties in The Scale of Cell Therapy Industry At present, the production
mode of the cell therapy industry maily depends on technicians. In the
10,000-grade clean laboratory, the cells are operated in a class 100 clean
bench, cultured in a carbon dioxide incubator, centrifuged in a centrifuge,
observed through an inverted microscope, and the drug reagents are stored in a
medicine refrigerator. All of these devices are operated by independent
biological laboratories of the individual and being linked together through
the operations of scientists. This type of production model is small in 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 issue of low efficiency but
high cost. Autologous or Allogeneic cells There are two kinds of cell sources
for cell therapy, one from the patients and the other from the allogeneic
tissue. Autologous cell therapy can not be standardized from the raw material
acquisition stage, and its cells are only applied to the patient itself, the
essence is essentially medical technology. The prevalence of autologous cell
therapy as a medical technology is mainly due to the scale of the predicament.
Allogeneic cell therapy, the cells derived from allogeneic. Taking tumor cell
immunotherapy as an example, the cell source may be from cord blood, and the
larger-scale cell source may be a filter plate for leukocyte filtration at the
blood bank. Taking umbilical cord mesenchymal stem cells as an example, the
cell source is the umbilical cord, and one umbilical cord-producing cell can
be used by more than one person. If scale can be cultivated, although the
quality standards cannot be quantified well, the scaled products themselves
have a certain degree of standardized properties.

The cell industry, as an industry, is not the path to the advancement of cell-
based therapeutics. If the advanced technology cannot be mass-produced on a
large scale, it can only stay in the laboratory and become the object of
research for scientists, never have achance to become a drug into the majority
of patients. For allogeneic cell therapy that using allogeneic cells as raw
materials, the standardized properties of the scaled products can be realized
if large-scale cultures are prepared, then scale and standardization can
promote each other. The current progress in standardization of cells is not
easy, but the progress in scale should be relatively easy to achieve.

