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.