Overview of biopharmaceutical technology

Biopharmaceutical is an applied science field with a long history and modern science and technology. Biodrugs contain very rich contents. Generally speaking, all drugs made of biological materials or by biological methods belong to biological drugs. Therefore, biological drugs in a broad sense should include microbial drugs produced by microorganisms, biochemical drugs extracted and processed from animal and plant tissues, vaccines and antibodies produced by microbial immunization technology, genetically engineered drugs produced by genetically engineered bacteria, biotransformation drugs obtained by biotransformation of microbial cells or biological enzymes, and drugs prepared by culturing animal and plant tissues and cells. Traditional Chinese medicine and herbal medicine are also biological drugs in essence, but because of their long history of development, they have become independent pharmaceutical systems of traditional Chinese medicine and are generally not included in the category of biological drugs.

Biopharmaceutical technology has gone through hundreds of years of development with the history of human struggle against diseases. From smallpox vaccination to penicillin treatment of infectious diseases; From the application of immunosuppressant-cyclosporine A in organ transplantation to the application of genetically engineered drugs-human growth hormone and interferon, the emergence of every new technology in the field of biopharmaceuticals has greatly benefited mankind and made great contributions to preventing and treating human diseases, improving the quality of human life and prolonging human life.

From 2 1 century to 200 1 year, the completion of human genome sequencing marks that human beings have reached a new level in their understanding of themselves and the nature of diseases. Thousands of disease-related genes have been located, and nearly 100 disease genes have been cloned, which will provide a new basis for the research and design of new drugs. Therefore, biopharmaceuticals will be one of the most active and attractive fields in 2 1 century.

This textbook is designed and compiled for training pharmaceutical talents in the 2 1 century under the organization of the National Research Association for the Construction of Higher Medical Textbooks and the Textbook Office of the Ministry of Health. Teachers from Shenyang Pharmaceutical University, China Pharmaceutical University, School of Pharmacy of Shandong University, School of Pharmacy of Shanghai Jiaotong University, School of Pharmacy of Fudan University and School of Pharmacy of West China of Sichuan University participated in the compilation of this textbook. They have worked in the field of biopharmaceuticals for many years and have rich teaching and scientific research experience.

This book focuses on microbial pharmacy, including biological extraction, genetic engineering pharmacy and biotransformation drugs catalyzed by microorganisms or biological enzymes. This textbook consists of three chapters. The first chapter introduces the theory and technology of biopharmaceutical biosynthesis and metabolic regulation, strain breeding, strain culture and preservation, culture medium and fermentation process control. The second chapter introduces the theory and technology of separation and purification of biopharmaceuticals, including traditional solvent extraction, ion exchange, adsorption, precipitation and chromatographic separation. It also includes relatively new separation and purification technologies, such as membrane separation, supercritical extraction and aqueous two-phase extraction. The third part introduces some specific biological drugs and their production processes, including antibiotics, amino acids, nucleic acids and nucleosides, peptides and proteins, biotransformation drugs and so on.