What Are Biologics?

Various forms of carbon-based organisms with medical research value are manufactured by traditional technology or modern biotechnology, which are used to prevent (health care), treat and diagnose various physiological symptoms of the human body. They are collectively called biological agents.

Chinese name: Biologics
Industry: Pharmaceutical industry

Raw materials: All kinds of carbon-based organisms with medical research value
Method: Traditional or modern biotechnology

Biologics concept

"Biological agent" in the pharmaceutical industry specifically refers to "immune biological agent", which refers to the processing of microorganisms (bacteria, rickettsia, virus, etc.) and their effective metabolites, animal toxins, human or animal blood or tissues, etc. It is made into biological products for prevention, treatment and diagnosis of corresponding infectious diseases or other related diseases. ^[1-2]

Medical biological agents ^[1]

The production of medical biologics, such as vaccines, broad-spectrum biologics, etc. has a series of characteristics in addition to the requirements for the production of all drugs. For example, there must be a first stage in production-the cultivation of microorganisms, viruses, and living cells, followed by subsequent processing of biological material, and at the same time it has the characteristics of cleansing, passivation, extraction, freezing, and lyophilization. For example, adalimumab needs aseptic conditions to complete many production processes, which meets the requirements of micro-contamination control. ^[1-2]

Health biologics

Harbin medicine calcium gluconate oral solution, calcium lactate, calcium gluconate, zinc lactate, vitamin D.

Ricafort antibacterial spray, the main ingredients are lactic acid, lactic acid bacteria, lactic acid bacteria and so on. The main effect is the care of antibacterial and antipruritic, reproductive infection diseases.

A brief history of the development of biological agents

Development stages of traditional biotechnology

Sumerian brewed beer 6000 BC

4000 BC Egyptian fermented bread

China's Yin Dynasty made sauce, Zhou Dynasty made vinegar ...

Features: Natural fermentation, all experience

Modern biotechnology stage

In 1673, Dutch microbiologist Anton Levenhoek invented a simple high power (300x) microscope and discovered the microorganisms.

In 1857 French scientist Pasteur proved the principle of fermentation.

Penicillin was discovered in Fleming, England in 1928.

In 1940, Flory and Chann of England separated penicillin.

Modern biotechnology

DNA double helix structure in 1953

Established DNA recombination technology in 1973

Established monoclonal antibody technology in 1975

E. coli expression of insulin in 1978

The emergence of PCR technology in 1988

1997 Clone Dolly

RNA interference technology in 1998

Biologics technology

DNA Recombinant DNA technology for biological agents

DNA recombination, recombination is the recombination of genetic material, which is usually accompanied by the process of genetic material transfer. The specific gene (donor) needed is artificially connected to the vector DNA, and then they are transferred to another biological host cell (acceptor) and integrated with the host cell DNA. When the host cell proliferates, the target gene It also changes with the proliferation, thereby changing certain genetic characteristics of the host cell and expressing the protein encoded by the gene of interest. It can also be said that the asexual splicing propagation method transmits genetic information.

Cell and Protoplast Fusion Technology

Cell fusion or cell hybridization refers to the process by which two or more cells merge into one binuclear or multinucleated cell through mediation and culture. Artificial cell fusion began in the 1950s. As a new technology from the 1960s to the 70s, it developed very fast and the application range was very wide. In addition to the fusion between the same kind of cells, the interspecies distant cells can also fuse. Cells are different from tissues. They do not exclude heterogeneous and heterogeneous cells, as do animal cells and plant cells. Cell fusion can not only be used for basic theoretical research in biology, but also has important application value in production practice, in the preparation of monoclonal antibodies, nuclear-plasmic relationship, somatic cell genetics and development, the cultivation of new varieties, and immune effects. Significant achievements have been made in the treatment of diseases, improvement of traits, and research on latent viruses.

Protoplast fusion technology for biological agents

Protoplasts are a general term for living matter in cells. Protoplast fusion has great significance in theory and practice, and has broad application prospects in plant genetic engineering and breeding research. It is one of the ways to obtain homologous and heteropolyploids in plants. It can not only overcome the sexual incompatibility obstacles of distant hybridization, but also overcome the traditional trouble of inducing polyploid plants through sexual hybridization. Distant genes from wild species are introduced into cultivars. Protoplast fusion technology is expected to become a powerful tool for crop improvement.

Biological agent plant detoxification and rapid propagation technology

Plant detoxification technology is to use high temperature treatment, stem tip tissue culture, and other methods to remove plant-infected viruses and cultivate animal and plant strains without viruses under ultra-clean and sterile conditions for vegetative reproduction, rapid breeding and production Virus-free seedlings and potatoes are suitable for field growth.

Rapid asexual reproduction technology, also known as micropropagation technology, refers to the technology of rapidly obtaining a large number of test tube bacilli through in vitro aseptic culture of plant embryos, tissues or organs. It opens up a new way to maintain the biological species, and to efficiently and quickly breed the offspring of good breeds.

Mass culture techniques for animal and plant cells

Cell culture: refers to a method of removing cells from a living body to isolate cells, and culturing under certain conditions so that they can continue to survive, grow, and proliferate. Advantages: Observe the law of cell life activity under the condition of in vitro, and it is not affected by the internal environment. It can artificially change the condition and further observe the change of physiological function.

Biologic animal embryo engineering technology

Embryo engineering is mainly to carry out some artificial engineering and technical operations on mammalian embryos, and then let it continue to develop and obtain new technologies of adult animals that people need. It is actually an extension and extension of animal cell engineering. As early as 1891, Hep of the University of Cambridge in the United Kingdom successfully performed fertilized egg transplantation experiments on rabbits for the first time. By the 1930s, this technology had gained more and more obvious benefits in animal husbandry. In the 1970s, companies specialized in fertilized egg transplantation appeared. Fertilized egg transplantation in higher animals is also called "livestock embryo transfer". It is a technique of taking the early embryos of good breeding stocks from the donor mother carcass, transferring them to the fallopian tube or uterus of the recipient female breeder, and "bringing pregnant women".

Modern microbial fermentation technology for biological agents

Bread, steamed bread, yogurt, wine, soy sauce, vinegar, sauce, kimchi, sauerkraut, fermented bean curd, baked rice, cheese, etc. are directly produced by microbial fermentation. Modern fermentation engineering has emerged since the establishment of the antibiotic industry, and independent fermentation industrial systems such as amino acids, citric acid, enzyme preparations, steroid hormones, vitamins, single cell proteins, and microbial pesticides have also emerged.

Protein engineering technology

The so-called protein engineering is to use genetic engineering methods, including site-directed mutation of genes and gene expression, to transform proteins in order to obtain protein molecules with more complete properties and functions. The modification and transformation of enzymes involved in important life activities in animals and plants is an important goal for the future development of protein engineering. Someday, people will be able to design and control the regulatory proteins that interact with DNA through protein engineering. By that time, they can artificially control genetics and transform lives.

Biologics related news

Biologics for rheumatoid arthritis and ankylosing spondylitis ^[3]

Modern medicine believes that both rheumatoid arthritis and ankylosing spondylitis are chronic systemic autoimmune diseases. Medical scholars have discovered through research that the culprit causing this type of arthritis is an inflammatory factor called "tumor necrosis factor", which can trigger joint synovitis, activate osteoclasts to cause bone destruction and joint deformities. As a result, medical scholars have developed biological agents to treat such diseases by inhibiting tumor necrosis factor.

At present, the tumor necrosis factor alpha (TNF-) antagonists that are used the most and have relatively small side effects are compared with traditional anti-rheumatic drugs that improve the disease. Its main characteristics are fast onset, obvious inhibition of bone destruction, The patient was generally well tolerated. The preparation mainly includes etanercept and adalimumab. ^[1-2]

Biological rheumatoid arthritis and ankylosing spondylitis are both autoimmune chronic diseases, which are characterized by high concealment, difficulty to diagnose, irreversible joint damage and high disability, which are often ignored by patients and the public. ^[4]

Rheumatoid arthritis has the characteristics of high concealment, difficult diagnosis, irreversible damage and high disability rate. ^[5] It can occur in any joint of the body, often in the small joints of the fingers, palms, and wrists. ^[1] ^[6]