Biomedical Engineering Reference
In-Depth Information
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. The benefits include a unique low pulsation peristal-
tic pump, constant pressure operation using pressure feedback and pump
speed control, process end-point via percent flux decay, cumulative vol-
ume/weight or processing time, innovative low dead volume t-connectors,
enabling the use of traditional pressure transducers, presized sterilizing-
grade filter and product collection assembly, ease of operation with an intui-
tive touchscreen interface, and user-defined process and alarm set points.
Virus filtration with Virosart
®
CPV is an integral part of the orthogonal
virus clearance technology platform at Sartorius Stedim Biotech (
www.sarto-
rius-stedim.com
)
. This orthogonal technology platform features virus filtra-
tion, virus inactivation, and virus adsorption. Virosart
®
CPV shows efficient
removal of both small nonenveloped viruses (20 nm) and large enveloped
viruses (>50 nm) from a biopharmaceutical feed stream by size exclusion.
The double-layer 20 nm PESU membrane of Virosart
®
CPV features excellent
flow rates and superior capacity. The filter offers highest viral safety over the
entire flow decay profile up to 90%. Virosart
®
CPV filters are being tested for
integrity using a water-based integrity test. All filters have been validated
for 4 log10 removal of small nonenveloped viruses using bacteriophage PP7
as a model virus. Each individual Virosart
®
CPV filter is autoclaved and
integrity-tested during manufacturing assuring highest product reliability.
Virosart
®
CPV provides highest viral safety to the biopharmaceutical prod-
uct. This filter retains more than 4 log10 of small nonenveloped viruses (por-
cine parovirus [PPV] or mouse minute virus [MVM]) and more than 6 log10
of large enveloped viruses (e.g., MuLV). Based on the unique double-layer 20
nm polyethylene sulfone (PESU) membrane, Virosart
®
CPV provides excel-
lent flow rates and superior capacity. This filter offers highest viral safety
over the entire flow decay profile of up to 90%.
Scale-down work is being realized using the Virosart
®
CPV Minisart (5
cm
2
capsule) to enable filtration work for flow and capacity studies as well as
for GLP virus spiking studies. Scale-up studies are being performed using
this capsule's size 9 with filter area of 2.000 cm
2
to reliably scale up into
larger-scale manufacturing. Typical batch sizes of products being subject to
nanofiltration with this Virosart® CPV capsule size 9 are 5 to 50 L.
Pall (
www.pall.com
)
offers Kleenpak Nova filters with either in-line or
T-style configurations. The T-style configuration is ideal for manipulating
multiple filters in series or in parallel configuration. Kleenpak Nova Capsule
filters incorporate either a 10 in. (254 mm), 20 in. (508 mm), or 30 in. (762
mm) length standard Pall cartridge filter, which have traditionally been
installed in stainless steel housings. In applications where a particular filter
is already specified, the user can switch from a stainless steel housing to
a fully disposable assembly with minimal requalification. This means the
extensive range of sterilizing-grade and virus filters currently available from
