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Bioprocess Vision 2012 - Issue 3 - Pall · PDF filebioprocessvision The system combines the advantages of Allegro single-use manifolds with an engineered automated system design, providing

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  • 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!

    Page

    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

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