Pharmaceutical quality constitutes the primary safeguard for human health, with Good Manufacturing Practice (GMP) serving as the definitive quality standard. GMP mandates stringent requirements governing....

Core Challenges in Biopharmaceutical and Biochemical Research: Thermolabile Substance Activity Preservation:Temperature-sensitive biological specimens (e.g., proteins, nucleic acids, vaccines) are prone to denaturation or inactivation during conventional drying or storage processes. High-Throughput Sample Processing:Requires simultaneous accommodation of large-scale production demands and small-batch operational flexibility. Low-Temperature Process Stability:Temperature-sensitive procedures (e.g., chromatography, purification) necessitate precise thermal regulation (1–15°C) to prevent separation efficacy compromise from thermal fluctuations. Cross-Contamination Mitigation:Multi-step protocols require minimized equipment-mediated contamination risks to ensure sample purity.

As one of the most dynamic high-tech industries in the world today, the biopharmaceutical industry is driving the rapid development of global health with its innovative scientific and technological strength and far-reaching medical impact. However, the high purity and high activity requirements of biological drugs make separation and purification technology a key factor restricting the development of the industry. In this context, tangential flow filtration technology, with its high efficiency and economic characteristics, provides strong technical support for the separation and purification links in the biopharmaceutical process, and has become an important force in promoting continuous innovation and optimization of the biopharmaceutical industry.