Biomedical Engineering Reference
In-Depth Information
species formed as a result of UVC exposure would be cleared in the subse-
quent polishing steps.
Planova filters (www.planovafilters) are the world's first filters designed
specifically for virus removal. The first Planova filter was launched in 1989
by the Asahi Kasei Corporation, one of the world's leading filter manufactur-
ers. Planova filters significantly enhance virus safety in biotherapeutic drug
products such as biopharmaceuticals and plasma derivatives. They exhibit
unparalleled performance in clearing viruses, ranging from human immu-
nodeficiency virus (HIV) to parvovirus B19, while providing maximum pro-
tein recovery. Planova filters contain a bundle of straw-like hollow fibers.
When a protein solution with possible viral contamination is introduced into
these hollow fibers, the solution penetrates the fiber wall and works its way
to the outside of the fiber.
Within these walls, there is an intricate, three-dimensional network of
interconnected void and capillary pores just nanometers in size. Viruses are
thus filtered gradually and effectively, while proteins migrate outward with
minimal adsorption and inactivation. Planova virus removal works on the
principle of size exclusion, unaffected by physical or chemical effects such as
adsorption. Therefore, even unknown viruses can be excluded as long as the
virus size meets the exclusion specification of the filter. Planova 15N, 20N,
and 35N filters are offered in 0.001, 0.01, 0.12, 0.3, 1.0, and 4.0 m² sizes. The 4.0
m² filter reduces the number of filters needed for a manufacturing cycle and
shortens cumulative integrity test time. The PVDF media Planova BioEX fil-
ter is offered in 0.001 and 1.0 m² sizes. Additional sizes, including 0.0003, 0.01,
0.1, and 4.0 m², are under development to extend the Planova BioEX line.
ChromaSorb membrane adsorber, an innovative, single-use, flow-through
anion exchanger from Millipore ( www.millipore.com ) , is designed to remove
trace impurities, including host cell protein (HCP), DNA, endotoxins, and
viruses. This device provides the greatest levels of impurity binding at the
highest salt concentrations for mAbs and other protein purification steps. The
ability to reliably perform at greater salt concentrations significantly reduces
buffer volumes. Compared to traditional column-based anion exchange res-
ins, ChromaSorb membrane adsorber reduces the validation requirements,
capital equipment expenditures, time, and labor. The ChromaSorb mem-
brane consists of a uniform 0.65 µm pore structure, ultrahigh-molecular-
weight polyethylene (UPE) membrane coated with a cationic primary amine
ligand for high binding strength for negatively charged impurities.
Mobius FlexReady Solution for Virus Filtration from Millipore ( www.
millipore.com ) provides the best combination of single-use assemblies
(Flexware assemblies), innovative separation devices, and process-ready
hardware specifically designed for virus filtration. It is preassembled and
pretested, and integrates easily into any process. Designed for applications
where feed volumes range between 1 and 200 L at protein concentrations
from 5 to 10 g/L, the Mobius FlexReady Solution for Virus Filtration features
Millipore's next-generation virus clearance solution, Viresolve Pro Solution.
Search WWH ::




Custom Search