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    bioprocess

    vision

    Page

    Market Trends 1

    Process Intensification Using New Single-Use Applications

    Product News 2 - 11

    New Products and Technologies for Bioprocessing Applications from Pall Life Sciences

    Interview 7

    Let the Column do the Packing Automated Packing/Unpacking at the Touch of a Button Rob Noel, Pall Life Sciences Business Development

    ACHEMA Congress 12

    Seven Reasons to Have a Closer Look Presentations by Pall Life Sciences

    Contents

    Issue 8 - April 2015 www.pall.com/biopharm

    Market Trends

    ACHEMA is getting closer! From June 15th to June 19th we will take another opportunity to present our latest technologies at the Frankfurt fairgrounds and there have been lots of exciting

    developments to Continuously Improving Bioprocesses. We look forward to sharing these with you!

    The following pages contain brief descriptions of the numerous technologies that we will showcase in an attractive and entertaining environment on our booth. One example is a disruptive innovation in single-use cell culture technology.

    This integrated turnkey process solution combines our new Allegro STR 1000 single-use bioreactor with our Stax single-use depth filters and our Supor EX ECV sterilizing-grade filters. This setup delivers a culture shift in upstream processing. It can be automated with an Allegro MVP single-use system to maximize process safety.

    The Allegro STR 1000 single-use bioreactor has been designed to resolve all challenges generally associated with single-use bioreactors. These single-use systems

    already well-established at small-scale are finding increasing use at process scales of 200, 1000 and even 2000 liters.

    After cell harvest with a Stax depth filter the product is transferred into downstream processing via a high capacity Supor EX ECV sterilizing-grade filter, which leads to unmatched productivity and protection of subsequent unit operations.

    Please familiarize yourself with the contents of this newsletter which details further novel innovations. We do hope you will decide to attend the show and look forward to extending a very warm welcome to you on our booth youll find us in hall 6.0, stand C74.

    Process Intensification Using New Single-Use Applications

    Further Information.

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    Dr. Dirk Sievers Editor

    Sign up to our enewsletter to keep informed.

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    Keep Informed!

    -Special

    Allegro STR 1000 Single

    -Use

    Bioreactor Demo

    Pall Life Sciences, Hall 6.0, C7

    4

    Daily at 3 pm

    www.pall.com/main/biopharmaceuticals/event-details.page?id=20140528092832

  • bioprocess

    visionSingle-Use Bioreactor for Cell Culture TechnologyThe Allegro STR 1000 single-use bioreactor represents a re-invention of the single-use bioreactor for cell culture processing. It is a geometrical scale-up from the Allegro STR 200 single-use bioreactor (see picture) with working volumes of 300 to 1000 L. It has been designed to resolve all challenges generally associated with single-use bioreactors, such as biocontainer integrity, operator and process safety during installation and disposal of the used biocontainer.

    The Allegro STR 1000 bioreactor embraces all the flexibility that single-use systems offer. The cubical design allows the most effective use of the footprint and acts as a natural baffle to improve mixing. A bottom driven impeller covers a large power input range to increase the design space. Extensive computational fluid dynamics and test data are available to assist with scaling.

    Pall optimized the packaging and the installation procedures to ensure easy installation and minimal risk of damage to the biocontainer. The software guides users through the biocontainer installation steps, assuring a complete, quick and safe installation.

    Flexible Automation for Single-Use ProcessesThe Allegro MVP system is a fully auto- mated platform that can be used across a range of upstream, downstream and formulation and filling activities, making it an invaluable tool in any bioprocessing facility. Applications include: sterile filtration, bioburden reduction, depth filtration, virus filtration/inactivation, media and buffer preparation, membrane chromatography, pH adjustment and final formulation and filling.

    A manifold selection tool facilitates selection of sensors, connectors, tubing type, filters and pre-filters needed for each application. Intuitive, easy to read labels on the manifold sets ensure easy, error free installation. The fully automated Allegro MVP system provides reliable control of process conditions and monitoring of all process variables, and the use of automated valves in the system allows more complex process steps to be simplified into an automated sequence.

    Good engineering design provides reliability, robust operation and minimizes operator error, with the high degree of automation enabling precise and consistent operation, control of key parameters, and minimizes operator contact.

    High Volume Sterile Fluid TransferKleenpak II sterile connectors enable biopharmaceutical manufacturers to make secure, permanent sterile connections of large single-use systems (> 100 L) or hybrid systems in an uncontrolled environment. They are suitable for a wide range of applications in biotech development and manufacture.

    Kleenpak II sterile connectors are ideal for use anywhere in a process where system components or sub-systems need to be connected, without compromising the sterility of the fluid path even in long operations. They are available in sizes of inch and 1 inch hosebarb and 1 inch sanitary flange.

    Secure permanent connection security

    Wide chemical compatibility

    Easy 4 step operation

    The connectors are free of animal-derived components and meet requirements for biological safety, non-pyrogenicity, extractables & particulates in accordance with USP criteria (USP , , , and ). They are 100% leak tested during manufacturing and can either be sterilized by autoclave or gamma-irradiation.

    Product News

    Further Information.

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    -Special

    www.pall.com/allegro-strhttp://www.pall.com/allegro-mvpwww.pall.com/kleenpak-connector

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    bioprocess

    visionProduction of Vaccines, Viruses and ProteinsThe iCELLis fixed-bed bioreactor technology has been validated from bench to process scale for the production of human and animal vaccines, viral vectors and recombinant proteins. The systems are available in two perfectly scalable platforms, the large scale iCELLis 500 single-use bioreactor and the scaled-down iCELLis nano single-use bioreactor.

    The systems are different from any other commercially available platform for adherent cell cultures, such as roller bottles, cell factories/cell stacks or stirred-tank reactors with microcarriers. They contain a compact fixed-bed of proprietary macrocarriers and provide up to 500 m of growth surface area in only 25 liters of fixed-bed.

    A built-in magnetic drive impeller evenly circulates media through the fixed-bed bioreactor and ensures low shear stress and high cell viability. The systems achieve and maintain high cell densities that equal or even exceed the productivity of larger stirred-tank bioreactor units. They can be supplied as part of a total single-use platform for upstream processing.

    High Density Adherent Cell CulturesSoloHill microcarriers provide relief from the limitations of 2D flatware culture, offering the advantage of a larger surface-area-to-volume ratio to support high adherent cell densities in suspension culture systems. SoloHill microcarrier technology is based on a solid polystyrene core which prevents absorption of serum, cell culture products and dissociation enzymes.

    The core can be modified with charge and/or ligands or coatings to foster cell attachment, and carriers are available in animal protein free formats. The polystyrene core also provides easy handling and preparation, immediate solubility, and multiple sterility options, including gamma irradiation. SoloHill microcarriers support cell growth and recovery at a variety of scales: spinner flasks, small to large scale stirred tank bioreactors, rocking platforms and microgravity bioreactors.

    Our newest product in this range, Hillex CT microcarriers, has the lowest particulate content of any microcarrier available today. They are an ideal substrate for expansion and recovery of stem cells for research and cellular therapy applications.

    Depth Filter Sheet for Vaccine ManufacturingThe Seitz P-series V100P filter sheet is

    a tailor-made depth filter sheet grade for

    the vaccine industry. It is ideal for

    efficient, robust and economic cell and

    cell debris removal from virus or

    virus-like-particle containing bulk,

    directly after cell culture.

    The grade V100P filter sheet is optimized

    to deliver high virus yield and significantly

    reduced turbidity, enabling best-in-class

    virus purification and protection from

    unwanted fouling in downstream

    processing. It is a flexible, compact and

    robust option for fine filtration of

    feedstreams in vaccine manufacturing

    and gene th