Research Progress of Microbial Quality Control and Rapid Microbiological Detection of Biological Products

As the key safety index of the quality control of biological products, microorganism is the critical parameter of process control and product release. The classic microbiological inspection is time-consuming and can’t feed-back the product status and process control in real time, which has a negative impact on short shelf life or the need for rapid release of biological products release cycle. Exploring alternative methods of rapid microbiological method(RMM) can solve the above problems and conform to the concept of process analysis technology. RMM based on microbial culture can determine whether there are microorganisms by analyzing the changes of physicochemical properties of culture medium, such as BacT/ALERT^® system. RMM based on living cell recognition mostly uses solid phase cell counting and flow cytometry. RMM based on the molecular level is determined by analyzing the characteristic molecules of microorganisms. Food and Drug Administration, United States Pharmacopeia and European Pharmacopeia all put forward the concept of RMM, and the first RMM Pallchek was used in the pharmaceutical industry in 2004. Since the 2010 edition, the Chinese Pharmacopoeia has also included guidelines for alternative methods of microbiological testing. In this paper, microbial quality control and rapid microbial detection methods of biological products are reviewed.