Issue 3 - April 2012 www.pall.com/biopharm
bioprocess
vision
PallLifeScienceswillshowcaseitsnewestlineupofleading-edgeproductsandservicestoenhancebioprocessingworkflowsattwoupcoming
internationalconferences.Thecompanywilldemonstratehowitstechnologiesforupstreamanddownstreamprocessingcanbe"YourPathtoBioprocessSuccess"indrugdevelopmentandproductionatInterphexandAchema.InterphextakesplaceMay1-3inNewYork,USA;AchemawillbeheldJune18-22inFrankfurt,Germany.
VisitorstoPallsboothswillexplorecriticalstepsinbioprocessinganddiscoverfastandflexiblesolutionsateverystageoftheprocess:FlexibilityinMediaPrep,ReliabilityinCellCulture,SimplicityinCellClarificationandCellHarvest,ScalabilityinDownstreamProcessing,SafetyinContaminantControlandPolishing,andConsistencyinFormulation,Filling,andPharmaQC.Wearehappytoexploreallthistogetherwithyou.
Onthefollowingpagesyouwillfindnumerousnewproductsworthconsideringforexistingornewprocesses.AtInterphexandAchema,allthesewillbefeaturedtogetherwithothergroundbreakinginnovations,amongstthemnewbioreactortechnologies,newchromatographysorbents,newmembranefiltersandnewdisposabledevicessuchassingle-useneedlesandplasticandtransportationtotes.
Wearehappytoprovidereliableandfullyintegratedsolutionsforthedesign,manufacturing,andserviceofourproducts.Allthesewillhelpyoutoensuretimelybiopharmaceuticalprocessdevelopmentandprocurementofproductioncapacity.WearelookingforwardtoseeingyousoonatInterphex,Achema,oroneofthemanyothereventsweattendallovertheworld!
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Market Trends 1Interphex and Achema 2012
Product News 2-4
AllegroTM Single-use TFF System: Fullyautomated with disposable manifolds
KleenpakTM Sterile Disconnectors: New variants for separation of single-use systems
Allegro Bioprocessing Workstations:Supporting flexible single-use systems
Palltronic AquaWIT IV System: Automated preparation/testing ofhydrophobic/hydrophilic filters
Fluorodyne EX Sterilizing Grade Filters: 5 in. configurations for smaller filter systems
PegasusTM SV4 Filters:For small virus removal
Mustang XT Acrodisc Units: Membrane adsorbers for scale-downprocess development
SentinoTM Microbiology Pump: Smallperistaltic pump with disposable fluid path
Acrodisc MS Syringe Filter: Certified for low extractables for LC/MS
Application 5
ISPE Facility of the Year Awards 2012
Interview 5
Two filters better than one? Jerold Martin, Pall Life Sciences, about recent discussions with regulators
Internet Highlights 6
Pall Biopharm Webinars: Online presentations of industry leadersand experts live and on-demand
Contents
Dirk Sievers, Editor
Market Trends
1Further Information.
Your Path to Bioprocess Success
bioprocess
vision
The system combines the advantages of
Allegro single-use manifolds with an
engineered automated system design,
providing reliable control of key parameters
and ease-of-use in manufacture.
Adopting a single-use approach for TFF can provide reductions in:
Systempreparationandcleaningtimeandcosts
Downtimeintheproductionarea
Riskofbatchorcrosscontamination
Validationtimeandcosts
The system has 12-in. tubing and a
feed pump capacity of 1000 L/hour.
It can be run with 20 L or 100 L feed
biocontainers, and run in fed batch
mode for processing larger volumes.
Single-use TFF manifolds:
Aresuppliedgamma-irradiated
Incorporatepre-calibratedsingle-useinstruments
Requiresimpleinstallation(15minutes)
TheadditionoftwosmallerdiameterversionsoftheKleenpaksteriledisconnector,in.and in.hosebarbformats,providesuserswithawiderrangeofapplicationpotential.
Typicalapplicationsinclude:
Sample biocontainer separation
for QC testing
Separation of fluid handling assemblies
around bioreactors
Disconnection of sterile filters for
offline integrity testing
Removal of sterile filtration sets from
filtered buffer or media
The Kleenpak sterile disconnector allows
for the separation of single-use systems,
whilst maintaining the sterility of, or
managing the general bioburden levels
within, the separated sections. The
demand for single-use systems integrating
sterile disconnectors is increasing at a fast
rate and the new size variants facilitate
wider application of these enabling
technologies, to further simplify operations
and improve process safety.
ThenewAllegrobioprocessingworkstationsfromPallprovideextremeease-of-usearoundoperationsandactivitiesthatutilizedisposableorsingle-usesystems.Thetypicalapplicationsthattheseworkstationscanbeusedforinclude:
Clarificationandproductstorage:usingStaxdepthfiltermodules
Filterandsingle-usesystemsupportforbufferfiltrationandstorage.
Chromatographyfractioncollectionandstoragearounddownstreamoperations
Sterilefiltrationsupportwithin situintegritytestingandproductstorage
Available in two basic formats (single or
double column width) and with a range
of frame extensions, plastic trays and
supporting hardware (such as filter
supports and document holders), these
workstations can greatly assist in the safe
handling, protection and general flexibility
for a wide range of operations from small
scale development activities through to
full scale production.
Product News
2Further Information. 3Further Information. 4Further Information.
Water Intrusion Testing is the most
convenient in situ integrity test for
hydrophobic filters. However reliable,
reproducible results can only be achieved
with suitable measurement methods and
tightly-controlled filling and temperature
conditions.
Palls new Palltronic AquaWIT IV system
utilizes the on-board Flowstar IV instrument
to control up to three pneumatic valves to
isolate the test filter, fill the housing/capsule
with water and perform the entire test
automatically. The system can also perform
a fully automated Forward Flow or Bubble
Point test for liquid filters.
Features
Fullyautomatedpreparationandtestingofhydrophilicorhydrophobicfilters
Allcriticaltestparameterscontrolledtoensurereproducibilityoftestresults
Fullysupportselectronicsignaturesaccordingto21CFRPart11
Internalopenprocesscontrol(OPC)serverforcommunicationwithprocesscontrolsystems
High capacity Fluorodyne EX filters with
built-in prefiltration are now available in
5 in. filter cartridge and filter capsule
configurations. These allow for the
downsizing of single 10 in. or dual stage
filter systems, and as a result, lower
filtration costs.
0.2 m-rated Fluorodyne EX grade
EDF membrane filters are recommended
for the sterile filtration of cell harvest,
process intermediates, and for some
niche applications such as the filtration
of liposomal fluids in vaccine
manufacturing.
0.1 m-rated Fluorodyne EX grade
EDT membrane filters combine high
capacity performance with additional
safety. With outstanding mycoplasma
removal efficiency for A. laidlawii and
M. orale (typically > 10 LRV), they are
a primary recommendation for filtering
cell culture media or growth media as
bioreactor feeds and used during
aseptic filling validation.
Coming soon: The new Pegasus SV4
small-virus removal filter offers constant,
stable flow-rate performance and
outstanding throughput capacity,
enabling maximum filtration economy.
It demonstrates highly-efficient clearance
of both small non-enveloped viruses and
large viruses, even showing constant,
stable flow-rate performance when used
with either dilute or complex/concentrated
biological fluids. It also offers stable
pressure/flux capability in more complex or
concentrated feeds, helping improve virus
filtration economy in highly-concentrated
protein solutions, without unnecessary
product dilution. Flow decay caused by
unwanted membrane plugging and gel
polarization is also kept to a minimum over
a wide range of process conditions and
extended process times. All of these
factors combine to ensure that Pegasus
SV4 virus removal filters can be established
as a platform technology enabling high
virus safety and significantly reducing
processing costs.
Product News
5Further Information. 6Further Information. 7Further Information.
Mustang XT Acrodisc units, the latest
addition to Palls membrane adsorbers,
are available in Q and S chemistries.
They have been designed to be fast, easy
to use, and ideal for scale-down process
development in a variety of applications.
These include protein purification and
sample preparation in research
laboratories, contaminant removal in
biotech and plasma fractionation as well
as contaminant removal and large molecule
capture in vaccines manufacturing.
The new units can be easily connected to
low pressure chromatography systems and
offer excellent performance over a broad
range of flow rates.
Features:
Devicevolumes
Regulatoryauthoritiesaroundtheworldpromoteriskassessmenttoensuredrugproductsafety.WeinterviewedJeroldMartinaboutrecentdiscussionswithregulators.
Jerry, how is the expectation of regulators changing with regard to drug products that cannot be sterilized in their final container?
Sterilizing filtration is still the norm for these
pro
