Applications
• Lysate clarification
• Upstream cell perfusion culture
• Inclusion body clarification and renaturation
• Nanoparticle Diafiltration and Separation
• Liposome concentration and diafiltration
• Cell concentration, clarification, diafiltration
• Purification, concentration, diafiltration of proteins and nucleic acids
• Virus purification, concentration, diafiltration
The production raw materials of this product meet the requirements of EMEA/410/01.
The technical parameters of this product meet the following regulatory requirements:
• Biological Reactivity Test, In Vivo per USP
• 21CFR177 Indirect Food Additives
• L929 MEM Elution test – ISO 10993-5(Cytotoxicity)
• Hemolysis – Rabbit Blood (direct contact) – ISO 10993-4
The production of this product meets the requirements of 15013485:2016 quality management system.