Nguyen Hue Linh, Pham Thi Minh Hue, Nguyen Thi Mai Anh, Bui Thi Thuong, Nguyen Van Khanh, Nguyen Thi Thanh Binh, Nguyen Thi Hai Yen, Dang Kim Thu, Bui Thanh Tung, Tu Minh Koong, Nguyen Thanh Hai

Main Article Content


The group of protein drugs has been developing very strongly, promising great advances in diagnosis, treatment, prevention, and human health improvement. Protein drug production is a large area of research, requiring advanced scientific and technological expertise, and integration of multi-disciplinary technology from fields such as biology, genetics, biotechnology, protein extraction and purification, and pharmaceutical manufacturing.

As protein drug manufacture involves biosynthesis processes using different cell lines, biopharmaceuticals have some distinct characteristics from small-molecule synthetic drugs, such as variability of biological processes, diversity of synthetic proteins, therefore leading to some differences in research and development, approval procedures, bioactivity testing, quality control and quality assurance and the production of “generic” biopharmaceuticals - biosimilars.

This article provides an overview of protein drug production from the initial stage to the finished product process, to identify and promote training activities, research and development, and knowledge transfer, contributing to the development of the biopharmaceutical industry in Vietnam, as well as effectively applying the drugs in clinical practice. Protein drug production is a valuable industrial field, with the goal of not only protecting and taking care of people's health but also developing national research, manufacturing, scientific and technological capacity, and bringing economic value.

Keywords: Protein drug, biopharmaceuticals, formulation, biosimilars.