Planova™ filters exhibit robust virus removability independent of protein loading amount and protein concentration. The figure on the right shows that Planova™ 20N exhibits an LRV of greater than 4.0 regardless of the concentration of PPV-spiked IgG solution, and that the LRV remains stable regardless of the IgG loading amount. Specifically, LRV of greater than 4.0 was observed up to 1100 g/m² for the 0.5% IgG solution, 1600 g/m² for the 1% IgG solution, and 500 g/m² for the 3% IgG solution.
The naturally hydrophilic properties of the cellulose membrane also allow for high permeability to protein. For instance, Planova™ 20N filter is designed to provide high recovery rates for proteins with molecular weights of up to 340 kDa, such as plasma-derived immunoglobulin G (IgG) and Factor VIII.
|Protein Recovery Rates|
The effects of virus spiking on Planova™ filters are minimal. The figure on the right shows that Planova™ 20N exhibits stable flux of human IgG solution. The flux decay is negligible and the flux profile of solution spiked with PPV is similar to that of solution not spiked with PPV.
Planova™ filters demonstrate consistent performance across all production lots of the hollow fibers contained. These hollow fibers are manufactured on dedicated spinning lines during continuous periods, and each period of continuous spinning on each spinning line is termed a “spinning series”. A "lot" of Planova™ filters is considered to be all of the filters manufactured using hollow fibers from the same spinning series. The figure on the right shows that three 4.0 m² Planova™ 20N filters, each containing hollow fibers from separate spinning series, exhibit very similar water fluxes. From this, it can be stated that Planova™ filters exhibit reliable lot-to-lot consistency.
Planova™ filters exhibit linear scalability across various membrane surface areas. Each filter size uses the same housing format and is filled with a scaled number and length of hollow fibers. This yields reliable scalability from laboratory scale filter sizes to commercial manufacturing scale filter sizes. Planova™ 15N, 20N and 35N filters are available in 0.001 m², 0.01 m², 0.12 m², 0.3 m², 1.0 m² and 4.0 m² sizes.