Blood products belong to the category of biological products, which mainly refer to biological active preparations prepared by biological processes or separation and purification techniques using healthy or special immune human plasma as raw materials, including all kinds of human plasma protein products, it includes human albumin, human placental albumin, human immunoglobulins for intravenous injection, all kinds of immunoglobulins (hepatitis B, rabies, tetanus immunoglobulin) , human coagulation factor VIII, human prothrombin complex, etc. S&P is able to provide a comprehensive solution for the clarification, ultrafiltration, virus-free filtration and terminal bacteria-free filtration in the production of blood products.
1 clarification:
The main objective of the clarification process is to remove cellular and granular impurities in the cell harvest fluid. The impurities are removed by the traditional process of two-stage centrifugation. At present, deep filtration is widely used in clarifying process steps.
Deep-bed filtration is the use of porous media from the mobile phase interception of solid particles rather than the surface interception, and the general medium surface with a positive charge, can be through electrostatic adsorption to intercept impurity particles.
Applicable products: SaiClear P series and S series clarifier filter, understand details →
2 ultrafiltration:
The main purpose of ultrafiltration is to concentrate the sample and transfer the solution into the preparation buffer. In addition to the conventional flux, the shear resistance of the target protein should be concerned.
Applicable products: Teomax PES ultrafiltration membrane package, understand the details →
3 virus removal:
Virus removal filtering is a common method of virus removal. Low-ph virus inactivation mainly inactivates lipid-enveloped viruses, not the elimination of lipid-enveloped viruses, such as mouse virus (MMV) . Because of their high resistance to chemical inactivation, viral membrane removal is required.
Applicable products: Valpha virus filter, understand the details →
4 sterilization and filtration:
Filtration is a process that removes microorganisms from a liquid stream without adversely affecting the quality of the product. In order to achieve the goal of sterility, the bacteria in the liquid or air clock are removed by the method of physical retention. The class of the sterilizing filter has been controversial, mainly because of the lack of consistency among manufacturers in measuring aperture. Because of the limitation of defining filter according to pore size, the definition of filter is based on bacteria retention capacity. PDA TR26 states that, under specified conditions, interception is per square centimeter within the effective filter surface area
B. Diminuta ATCC 19146 capacity of 107 filters are defined as bactericidal grade filters.
Applicable products: sterilization and filtration of terminal feed: SaiPress 0.22 μm for details →
Medium filtration: SaiPress 0.45 + 0.22 μm for details →
Buffer filtration and pre-column protection: Polysai pre-filter, SaiPress 0.22 μm for details →
Gas Filter & Respirator: Filgiant 0.22 μm for details →