Cobetter Irradiated ATF Hollow Fiber Products
Cobetter Irradiated ATF Hollow Fiber Products Suspended cell culture technologies primarily encompass three mainstream modes: perfusion culture, fed-batch culture, and batch culture. Currently, the domestic biopharmaceutical industry employs fed-batch culture as the primary production method. However, perfusion processes are gaining increasing attention due to their distinct advantages. Compared to fed-batch systems, perfusion systems enable faster seed cell expansion and maintain long-term stability of high-density cell cultures during the N stage. By enabling real-time product harvest, perfusion processes significantly enhance production efficiency. Furthermore, this approach ensures consistent product quality while reducing capital investments in production facilities and ancillary equipment. The core of perfusion technology based on hollow fiber systems lies in establishing a closed cultivation system that integrates an ATF hollow fiber column, tangential flow control systems, and bioreactors. This system effectively retains cells within the cultivation vessel and employs intermittent or continuous medium exchange strategies to create an optimized microenvironment for cell growth.
Water for Injection (WFI) Preparation By Membrane May Become Possible
Water for Injection (WFI) Preparation By Membrane May Become Possible Recent regulatory developments, particularly within the European Pharmacopoeia (Ph. Eur.), are accelerating the acceptance of membrane-based technologies for producing Water for Injection (WFI). The Ph. Eur. now explicitly permits non-distillation methods — such as reverse osmosis (RO), electrodeionization (EDI), and ultrafiltration — provided they achieve performance equivalent to traditional distillation in removing chemical impurities, microorganisms, and endotoxins. Experimental data using a Cobetter 6 kD hollow-fiber membrane show promising results, achieving endotoxin levels <0.02 EU/mL under high-load challenge conditions. As additional regions, including China, consider aligning with European guidance, membrane-based WFI generation is emerging as a scientifically robust and regulatory-supported alternative for pharmaceutical manufacturing.