Mcab is the abbreviation of monoclonal antibody drug. mcab has made rapid progress in the treatment of cancer, tumor and immune diseases because of its high specificity, little side effect and simple purification process. It plays an important role in the field of biotechnology pharmacy, and has gradually become the main direction of development in the field of biomedicine. S&P offers a full range of downstream purification and separation solutions for mcab clients, including packaged solutions ranging from clarifier filtration, ultrafiltration, virus removal to final germ-free filtration.
1 clarification filter:
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 for details →
2 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 →
3 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. In the modern antibody technology, with the development of the technology and the increasing market demand for high-dose administration, the protein concentration that the major drug manufacturers can achieve is also getting higher and higher, therefore, the stability of the target protein at high concentration should be concerned.
Applicable products: Teomax PES 30KD D channel ultrafiltration membrane package, 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. The bacteria in liquid or air can be removed by physical retention filter to achieve the goal of Asepsis. 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 →