Biopharmaceutical is the use of biotechnology to produce natural active substances in living organisms. Its effective ingredients are usually some bioactive proteins, DNA, viruses, cells or tissues, etc. the administration method is direct tissue injection.

Disposable, integrated and large-scale are the development trend of cell gene therapy production equipment and technology.

After the cells are inoculated or subcultured, the experimenter should make routine examination of the cells every day or at most 1 ~ 2 days. Observe the morphology and growth of cells, as well as the pH change of culture, whether there is pollution, etc. According to the dynamic changes of cells, do fluid replacement or passage treatment. If abnormal conditions are found, take measures in time.

Experts believe that automation and informatization are the only way to ensure the quality of drugs. If this is not well understood in the industry, it is relatively difficult to promote this aspect. In terms of automation, the production process of the pharmaceutical industry can not simply apply automation, which can change some problems, especially in pharmaceutical equipment.

01 introduction to biopharmaceutical Biopharmaceutical is a product for prevention, treatment and diagnosis that uses biotechnology to separate effective components from organisms, biological tissues, cells and body fluids. Biopharmaceutical is an interdisciplinary comprehensive field formed by the combination of biotechnology and the pharmaceutical industry, covering chemical pharmaceuticals, biotechnology drugs, traditional Chinese medicine, medical devices and health industries. It is one of the most active fields in the current international scientific frontier. Biopharmaceutical raw materials are mainly natural biological materials, so the safety is relatively high and the side effects are relatively small. These significant advantages make biopharmaceutical accepted by more and more people, and it is also one of the reasons for the rapid development of biopharmaceutical. At present, biopharmaceutical is the industry with the most extensive application of biotechnology, and is also considered to be one of the most promising industries in the 21st century. Biopharmaceutical products include antibodies, vaccines, blood products, cell therapy, recombinant proteins, diagnostic reagents, etc., which are mainly used for the treatment of tumors, AIDS, cardiovascular and cerebrovascular diseases, hepatitis, autoimmune diseases and metabolic related diseases.

Biological agents are not only different from general drugs in raw materials, but also in production processes. In short, it uses modern biotechnology to produce drugs with the help of some microorganisms, plants or animals. Protein or nucleic acid drugs developed by DNA recombination technology or other new biological technologies also become biological agents. Pure biological agents, that is to say, they do not contain traditional chemical drugs except excipients.

In the pharmaceutical industry, cell culture has become an important part of antibody production. Cell culture technology has been used to produce antibodies against rotavirus, poliomyelitis, smallpox, hepatitis, rubella and chickenpox. Cell based influenza antibodies have also been approved for use in the United States and many European countries. What is the prospect of cell culture?

The outbreak of covid-19 (covid-19) since the beginning of 2020 has changed China, the world and everyone's life. Of course, the development of the vaccine industry in the new era of the epidemic has also ushered in new historical opportunities. COVID-19 is testing the global supply chain. As one of the key areas highly dependent on the global supply chain, biopharmaceutical is facing problems such as shortage of pharmaceutical raw materials and insufficient production capacity. The surge in global demand for vaccines in the short term also has an impact on the supply of biological drugs.

Cell culture technology is also called cell cloning technology, which is a formal term in biology. Whether for the whole bioengineering technology or one of the biological cloning technologies, cell culture is a process of cell replication, and cell culture itself is a large-scale cloning of cells. Cell culture technology can turn a cell into a simple single cell or a few differentiated multi cells through mass culture, which is the link of cloning technology, and cell culture itself is cell cloning. A large number of cells or their metabolites are obtained through cell culture. Because biological products are derived from cells, it can be said that cell culture technology is the core and basic technology of biotechnology