中文(简体)Biotechnology refers to the use of advanced scientific and technological means based on modern life sciences, combined with the scientific principles of other basic sciences, to transform living organisms or process biological materials according to predetermined designs, in order to produce desired products or achieve certain goals for humans. Biotechnology is a technology that utilizes microorganisms, animals and plants to process raw materials, and serves society by extracting products. Biotechnology mainly includes fermentation technology and modern biotechnology. Therefore, biotechnology is an emerging and comprehensive discipline.
Modern biotechnology integrates multiple disciplines such as genetic engineering, molecular biology, biochemistry, genetics, cell biology, embryology, immunology, organic chemistry, inorganic chemistry, physical chemistry, physics, informatics, and computer science. It can be used to study the laws of life activities and provide services to society.
In recent years, modern biotechnology represented by genetic engineering, cell engineering, enzyme engineering, and fermentation engineering has developed rapidly and is increasingly influencing and changing people's production and lifestyle. The so-called biotechnology refers to the technology of using living organisms (or substances from living organisms) to improve products, improve plants and animals, or cultivate microorganisms for special purposes. Bioengineering is a general term for biotechnology, which refers to the use of principles such as biochemistry, molecular biology, microbiology, genetics, etc. combined with biochemical engineering to modify or recreate the genetic material of designed cells, cultivate new varieties, utilize existing biological systems on an industrial scale, and manufacture industrial products through biochemical processes. In short, it is the process of industrializing living organisms, life systems, or life processes. Bioengineering includes genetic engineering, cell engineering, enzyme engineering, fermentation engineering, bioelectronics engineering, bioreactors, technology, and emerging protein engineering, among which genetic engineering is the core of modern biotechnology. Genetic engineering (also known as genetic engineering or gene recombination technology) is the process of splicing and combining genes from different organisms in vitro, connecting them with the DNA of vectors (plasmids, bacteriophages, viruses), and then transferring them into microorganisms or cells for cloning. The transferred genes are then expressed in cells or microorganisms to produce the required proteins. More than 60% of biotechnology achievements are concentrated in the pharmaceutical industry, used to develop characteristic new drugs or improve traditional medicine, which has led to significant changes in the pharmaceutical industry and the rapid development of biopharmaceuticals. Biopharmaceuticals is the process of applying biotechnology to the field of drug manufacturing, with genetic engineering methods being the main approach. By utilizing cloning technology and tissue culture techniques, DNA is cleaved, inserted, connected, and recombined to obtain biopharmaceutical products. Biopharmaceuticals are biologically activated preparations made from microorganisms, parasites, animal toxins, and biological tissues, using biological processes or separation and purification techniques, and controlling the quality of intermediate and finished products through biological and analytical techniques. They include vaccines, vaccines, toxins, toxoids, serum, blood products, immune preparations, cytokines, antigens, monoclonal antibodies, and genetic engineering products (DNA recombinant products, in vitro diagnostic reagents). Biopharmaceuticals that have been developed and entered the clinical application stage by humans can be divided into three categories based on their different uses: genetic engineering drugs, biological vaccines, and biological diagnostic reagents. These products play an increasingly important role in diagnosing, preventing, controlling, and even eliminating infectious diseases, and protecting human health.
The development of new biological products generally requires (1) laboratory research (exploration of production process routes and establishment of quality control standards); (2) Preclinical research (animal experiments such as pharmacology, toxicology, and efficacy); (3) Health food needs to undergo safety testing of tested products; (4) And drugs need to go through five stages of research work, including Phase I clinical trials (testing the safety of drugs with healthy volunteers), Phase II clinical trials (small-scale clinical pharmacodynamic studies), and Phase III clinical trials (large-scale clinical pharmacodynamic studies), in order to be approved for trial production. After one year of trial production, drugs must be reported for quality stability and further expanded clinical trial results before applying for formal production approval.
