l bioprocess vision - pall.fr Vision Newsletter... · 1 bioprocessvision Page Market Trends 1 Process Intensification Using New Single-Use Applications Product News scales of 200,

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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 – you’ll 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

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-Special

Allegro STR 1000 Single-Use

Bioreactor Demo

Pall Life Sciences, Hall 6.0, C74

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 automated 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 ¾ 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 <88>, <87>, <85>, <661> and <788>). They are 100% leak tested during manufacturing and can either be sterilized by autoclave or gamma-irradiation.

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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 m² 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 therapy.

Grade V100P is ideal for use with Pall's

versatile, easy-to-use and well-established

Stax depth filter capsule system. It helps

to develop cell removal steps by

providing reliable scale-up results, from

trial sizes in benchtop format to full-scale

manufacturing.

Providing all the benefits of single-use

products, this new cell removal solution

will help you to simplify and streamline

your entire viral vaccine manufacturing

process.













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bioprocess

visionAutomated Columns for Process ChromatographyWith scalable multi-axis piston control and fully automated packing, unpacking and CIP, the family of Resolute® Linear chromatography columns represents a major advance in reducing process risks associated with moving from pilot-scale to large-scale column packing.

Resolute Linear chromatography columns are designed for large-scale pilot and production use. The range is available from 400 to 1200 mm internal diameter, in all common sizes. The columns utilize the proven Resolute wetted flowpath providing low pressure drop and high-resolution chromatography over a wide range of normal operating flow rates. The Resolute nozzle valve allows packing and unpacking without opening the column.

• Fully automated, push button operation of packing, unpacking, and clean-in- place (CIP) • Intuitive software • Fully scalable multi-axis control for active piston levelling • Multiple built-in parameter driven method templates • In-built maintenance function • Ability to empty tank during packing • No extra pumps or packing skids required

Screening, Optimization and Scale-upScreenExpert Toolkits offer a selection of Pall chromatography sorbents provided in a single box. They are supplied with AcroPrep™ ScreenExpert Plates or ScreenExpert RoboColumns or PRC columns (1 mL, pre-packed) or individual labpacks (bottles of sorbents). They contain a detailed protocol to simplify screening, optimization and scale-up of purification steps.

AcroPrep ScreenExpert Plates are a family of pre-filled 96-well filter plates with 50 µL of sorbent per well.

• Disposable format in convenient individual packaging • Manual or robotic workstation-assisted operation

ScreenExpert Robocolumns are pre-packed miniaturized columns to mimic chromato-graphy in dynamic mode.

• 200/600 µL of sorbent with 10/30 mm of bed height • Fully automated handling by robotic workstations

A lot of experimental conditions can be tested with both formats reducing sample consumption and saving time. ScreenExpert Toolkits are the ideal tool to test the latest Pall ion exchangers and mixed mode sorbents.

Continuous Concentration and Optimization in DSPPall’s single-pass tangential flow filtration (SPTFF) is a new technology that utilizes a staged flow path design for continuous concentration with only one pump pass. SPTFF technology significantly minimizes shear exposure and enhances product quality.

Optimized flow path and design greatly reduce the system working and hold-up volumes compared to conventional TFF, resulting in improved product recovery. SPTFF technology provides a simple solution for continuous concentration and optimization of DSP steps.

The Cadence™ Inline Concentrator (ILC) module is a holder-less SPTFF device with a retentate flow restrictor to achieve typical concentration factors of 2 to 4x.

The ILC module requires only a feed pressure source and a feed pressure sensor for operation.

This easy-to-use device can be imple-mented in biotech DSP processes for continuous processing or for in-process volume reduction (i.e. before and/or in-between chromatography steps) for potentially savings in time, buffer usage and resin cost.

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visionAutoPak Technology for Process ChromatographyBuilding upon Pall's proven and well- established Resolute hydaulic column functionality, AutoPak Technology is a combination of hardware and software which automates three of the key unit operations necessary in process chromatography: packing, unpacking and CIP.

These key unit operations, particularly packing, are regarded as labor intensive, high risk events. The risks include human error, packing failure and absence of experienced operators. The result can be expensive plant downtime, loss of product or sorbent and inefficient use of resources.

By adopting a fully automated approach AutoPak functionality greatly simplifies operation, effectively eliminating operator error and reducing the burden on key operators. The automated sequences assure that reproducible, consistent operation is the norm.

All hydraulic and electrically actuated Resolute columns feature three axis leveling to ensure the piston is kept safe and stable under all conditions. No additional equipment is required, such as packing skids or pumps.





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What are the main reasons to use automated packing technology for chromatography columns?

As with many other

industries, automation

can improve manu-

facturing consistency and efficiency in

biopharmaceutical production. In this

context that means consistently achieving

a process-ready pack of the process

chromatography column, maximizing

production time.

Automation creates operator-independent

procedures; as well as opening up the

procedure to a wider range of operators

it makes for simpler transfer within

facilities of different geographies and

scales. This is the requirement for

process chromatography nowadays and

this is the offering of our innovative

AutoPak technology.

How does the Autopak technology from Pall meet these demands?

The AutoPak system offers automated

packing and unpacking at the touch of a

button. The system is simple to prepare

and easy to operate, effectively eliminating

undesired operator error through complete

computer-controlled SOP execution

and feedback control. The series of

preinstalled template procedures has

been optimized for quick turnaround,

reduced buffer consumption and

repeatable results.

How is AutoPak different from other systems on the market?

The AutoPak system fully automates the

packing, unpacking and cleaning (CIP)

steps with no need for additional pumps

or systems; other systems on the market

are semi-automated and require significant

operator input during each operation

increasing the risk of operator error.

For maximum process security we use a

multi-axis piston levelling system which

can detect and prevent piston skewing

before damage to the column can occur.

The ability to empty the slurry tank during

packing is unique in the market - this

feature is key to reducing adsorbent

costs and validation issues, particularly in

affinity capture steps.

Is this technology just for commercial scale manufacturing?

The AutoPak system certainly assists

manufacturing processes with larger

chromatography column diameters (up to

2000 mm ID) and is therefore likely to be

used for commercial products. But

columns as small as 30 cm or 40 cm

inner diameters can also benefit from

being "autopacked" and this places the

technology as an option for pilot plants.

The same inputs are used for pilot as well

as commercial columns – so scale-up

when required is a low risk operation.

Also, the ease with which a column can

be unpacked and repacked in-situ, in the

cleanroom, really makes the AutoPak

technology suitable for much more

flexible manufacturing.

Interview

Rob Noel Business Development Pall Life Sciences

Let the Column do the PackingAutoPak technology revolutionizes the packing of process chromatography columns. A simplified approach for highly reproducible packing offers numerous advantages and benefits which initiate a new era of bioprocessing.

http://www.pall.com/main/biopharmaceuticals/product.page?lid=hrch8nf8

bioprocess

visionScalable Membrane Adsorbers for DSPMustang® Q membrane chromatography devices are ready-to-use membrane adsorbers with bed volumes from approx. 1 mL to 5 L. They are designed for capturing or for impurity removal in bioprocesses.

These ion exchange supports are polyethersulfone-(PES)-based membranes, with 0.8 µm pore size, and a cross-linked polymeric coating of quaternary amine functional groups. They provide high dynamic capacity, especially for large molecules.

The multi-layer membrane construction is held at constant thickness/bed depth from laboratory to process scale. The devices are more compact than other membrane adsorbers or conventional beaded sorbents, providing significant buffer savings.

• High volumetric flow rates for short process times

• High throughput and reduced buffer consumption

• Process flexibility through small footprint

The range is completed by AcroPrep 96-well plates with Mustang membranes, to allow a quick screening of conditions before scale-up using the 1 mL device. Mustang Q membrane devices are available as single-use or reusable capsules.

.

Single-Use Modules for Cross Flow FiltrationCadence modules for single-use tangential

flow filtration (TFF) are ready-to-use

gamma irradiated ultrafiltration (UF)

cassette modules designed for

single-use application that allow for a

simpler, easier and safer single-use TFF

solution for R&D, clinical or commercial

manufacturing.

They can easily be integrated into Allegro

single-use TFF systems or other single-

use TFF set-ups. Allegro single-use TFF

systems are engineered automated

systems with a reliable control of key

parameters, enabling ease-of-use and

process flexibility in manufacturing.

Cadence single-use TFF modules provide

increased ease-of-use, quick turnaround,

safety and containment in cGMP operations.

They can be easily implemented in

single-use TFF systems for concentration

and diafiltration steps from R&D to

commercial production of biotech products,

antibody drug conjugates or vaccines.

The single-use modules integrate the

process-proven Omega™ polyethersulfone

(PES) membrane and are available in

scalable formats from 93 cm² up to 2.5 m²

of membrane area.

Single-Use TFF System for BioprocessingThe Allegro single-use TFF system combines the advantages of Allegro single- use manifolds with a well-engineered automated system design, providing reliable control of key TFF process parameters. Pall offers a range of SUTFF system sizes to run Cadence single-use TFF modules or Omega / Delta cassettes with membrane areas ranging from 0.1 to 10 m2.

Benefits of adopting an Allegro system for SUTFF processing include:

• Process safety and robustness, provided by fully automated processing and reproducible, reliable process performances

• Single-use flowpaths mean no batch or cross contamination, less validation time and costs for cleaning requirements

• Ease of use in installation, operation, and disassembly. Ready-to-use solutions, with fully disposable flowpath and Cadence SUTFF modules

• Process economics. Cost of goods analysis shows significant savings in capital, materials, labor and facility operating costs, delivering increased productivity and better resource allocation

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bioprocess

visionHigh Safety, Quality and Efficiency with Compact FiltersDrug manufacturers seek sterilizing-grade filters that meet their exacting standards for high quality sterile drug products. It is also important that filters can demonstrate throughput performance that allows for the operation of efficient and practically-sized filtration systems.

Pall’s 0.2 micron-rated sterilizing-grade Supor EX grade ECV filters have been designed for use with a broad range of fluids in biopharmaceutical manufacturing processes. They are capable of filtering the highest volumes of fluid until user-defined process limits of flow rate or differential pressure are reached.

Supor EX grade ECV filters are available in single use filter capsule configurations designed to filter batch volumes of 50 L upwards. The filter membrane and pleating technology incorporated into these products deliver excellent capacity for feeds such as cell culture growth media and clarified cell harvest, and high flow rates for low fouling feeds such as buffer solutions for downstream processing, e.g. for chromatography or diafiltration.

Sterilizing-Grade Filters for Extreme Air/Vent ApplicationsEmflon® HTPFR filter cartridges are spe-

cifically designed for the sterile filtration of

air, gas and vent service in critical, high

temperature and ozonated-water venting

applications in the biopharmaceutical

and biotechnology industries. They can

also be used in oxygen-enriched air

applications.

High-temperature air/vent applications

include fermentation inlet air, aseptic

packaging/blow-fill-seal (BFS), hot

water-for-injection (WFI) tank vents and

autoclave vents. These filters incorporate

a double-layer of inherently hydrophobic,

Pall-manufactured 0.2 µm rated

polytetrafluorethylene-(PTFE)-membrane.

The polypropylene filter hardware is

specially formulated with protective

anti-oxidants and the filter’s support and

drainage layers are made of an oxidation-

resistant polyphenylene sulfide polymer.

These purpose-engineered filter

components allow extended use in air/

vent service up to 100 °C and for shorter

periods up to 120 °C.

Virus Removal Filters for Superior Cost Control and SafetyPegasus™ SV4 Virus Removal Filters combine high viral clearance and process capacity for cost-effective reduction of small non-enveloped viruses and larger viruses.

The innovative Pegasus SV4 filter membrane ensures high process capacity with a constant and stable flow-rate when used with either dilute or complex/concentrated biological fluids. This performance significantly improves virus filtration economy in highly concentrated protein solutions.

Pegasus SV4 filters are available in a range of autoclavable cartridge filters and single- use capsules from small scale to large scale. The cartridge filters are also fully compatible with SIP (steam-in-place). An easy and reliable water-based in-situ filter integrity test can be applied pre-use and post-use.

The virus filter is complemented by Pall’s automated virus filtration systems including the new Allegro MVP system designed with a fully disposable fluid path. All these systems enable consistent and precise operation with improved process efficiencies.













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bioprocess

visionPoint-of-Use Testing of Single-Use SystemsThe fast uptake of single use technology in biopharmaceutical formulation and filling leads to increased requirements in both validation and robustness of single use systems. As a direct result of this, point-of-use testing of single use systems is quickly becoming a requirement to confirm the absence of leaks prior or after use from a risk management perspective.

The new Palltronic® Flowstar LGR device provides end users with the capability to perform an easy and reliable true point-of- use leak test of single use systems. In addition the device also allows for integrity testing of the filters within the single use systems.

• Leak testing of any type of single-use systems with a nominal volume of 200 L or less

• Integrity testing of any filters within the single use assembly

• Very short testing time (shorter than 15 minutes)

• Reduced footprint and fully suitable for manufacturing operations

• CFR 21 part 11 compliance of software package

Single-Use Biocontainer Systems and HardwareThe introduction of a 50 liter version of our "easy-fill" 3D biocontainer format expands the portfolio of Allegro single-use biocontainers. The 50 L 3D biocontainer has a small footprint for easy operation, which includes easy sampling through a standard small bottom port.

This new size allows the handling of up to 50 liters in an easy-to-use format, which can be operated with flexible Allegro plastic totes and supporting stainless steel hardware.

The new 50 L 3D biocontainer can either be used on a mobile Allegro bioprocessing workstation with plastic totes (up to six 50 L totes on one workstation; see picture) or in a stand-alone benchtop plastic tote. Applications include, amongst others, media storage or supply in USP, buffer storage or fraction collection in DSP, and use as a bulk product container in formulation and filling.

Allegro biocontainers with our "easy-fill" 3D design are available from 50 to 1500 liters. All systems (including the smaller 2D volume range) incorporate a state-of-the art Allegro polyethylene film for consistency of materials, high quality and scalability across the whole range of Allegro biocontainers.

Single-Use Needles for Final FillingAllegro single-use filling needles are a ready-to-use and cost-effective disposable solution for final filling applications. These plastic needles are made of PEEK (Polyether Ether Ketone). They are compatible with a broad range of commercial and clinical filling machines and can also easily be integrated into Allegro single-use filling systems.

Allegro single-use filling needles eliminate cleaning, verification and validation thus also eliminating the risk of cross contamination.

They comply with USP <85> and <788> requirements for endotoxin and particulates in injectables to ensure no pre-flushing is required. They also meet biological reactivity requirements under USP <87> and <88> for class VI plastics post gamma irradiation and autoclave.

The needles are available with 0.8 mm, 1.6 mm, 3.2 mm, 4.0 mm, 5.0 mm and 6.0 mm internal diameters. They can be autoclaved or gamma–irradiated. A tight control of straightness and wall thinness during manufacturing allows high efficiency bottom-up filling with no drip formation. Each needle is labelled with part number and batch number for full traceability.













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bioprocess

visionHigh-Performance Mixing for Single-Use OperationsThe Allegro 50 L single-use mixer is an easy-to-use high performance mixer for manual to automated solution preparation between 2 and 50 L. It is a scale down version of the established larger Allegro mixers (200 L, 500 L and 1000 L) with the additional feature of an advanced impeller design to facilitate low volume mixing down to 2 L.

The mixer either incorporates a plastic tote or a jacketed stainless steel tote. It can incorporate sensors (e.g. pH, conductivity and temperature) for on-line monitoring and control as well as a weighing platform.

The mixer can be integrated to the automated Allegro MVP single-use system to fully automate mixing and filtration processes, including fluid transfer to and from the mixer.

The mixer is designed to provide exceptional mixing for a wide range of applications from upstream through downstream process to formulation and filling. It lends itself especially well to difficult applications like mixing dense powders or high viscosities, applications requiring repeatable, fast mixing performance, or where biologicals sensitive to shear are being mixed.

Magnetic Mixer for Buffer and Media PreparationThe Pall Magnetic mixer is a flexible and mobile single-use mixing system ideal for solid to liquid applications requiring robust mixing. The system allows efficient and reproducible single-use mixing of a wide range of volumes in a broad series of biopharmaceutical applications. It exhibits especially strong performance in buffer and media preparation.

The Magnetic mixer consists of an interchangeable magnetic drive unit and proprietary magnetic-impeller single-use mixing systems. These systems are fitted into containers on either a portable dolly or a floor mounted tank. The drive motor is enclosed on a portable cart that can be easily transferred between containers, which allows mixing in multiple systems of various sizes with a single drive unit.

The Magnetic mixer has been engineered for GMP certified cleanrooms without complex instrumentation to control the mixing process. It utilizes single-use mixing systems (30 to 3000 liters) made from Pall's Allegro TK8 film. The product- contacting film layer is blow-extruded in-house under cleanroom conditions using a medical-grade ultra low-density polyethylene resin.

Superconductive Levita-tion for Superior MixingThe LevMixer® system is specifically designed to fulfill the needs of the bioprocess industry. The flexible and mobile single-use system allows efficient and reproducible mixing of a wide range of volumes in a broad series of applications ranging from buffer preparation in downstream processing (e.g. for chromatography or diafiltration) to final formulation.

The LevMixer system consists of an interchangeable superconducting drive unit and proprietary levitating impeller-based single-use mixing systems fitted into containers on either a portable dolly or a floor mounted tank. This allows mixing in multiple systems of various sizes (ranging from 30 to 2000 liters) with a single drive unit to reduce capital investments and improve process efficiencies.

The superconductive levitation technology enables slow impeller speed for smooth treatment of fragile or shear sensitive samples. It avoids mechanical shear stress or particle generation to ensure product integrity. The mixer efficiently works without any shafts, seals or bearings inside the single-use mixing system.













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bioprocess

visionSteam Sterilization of Critical ComponentsNewform™ Easy-Tear Cleansteam bags are ultra clean bags designed for increased process efficiency to fulfill the most stringent requirements in the sterilization process of final fill components such as stoppers, syringes or vials and stainless steel process equipment. A sterilization indicator changes color when exposed to steam.

Easy-Tear Cleansteam bags are made of high density polyethylene (HDPE) and Tyvek. They show outstanding performance in terms of cleanliness, material and seal strength, as well as microbial barrier properties thus providing highest sterility integrity until the packaging is opened. They are manufactured with low bioburden, endotoxin and particle levels in state-of-the-art ISO Class 5 cleanrooms.

Easy-Tear Cleansteam bags enable easy opening without the need for knives or scissors or any other tools. This feature virtually eliminates the risk of particle generation and accidental damage to gloves that could occur when using cutting devices, making it safer and more efficient to use in an isolator or sterile environment.

Particle Validation Standard KitsThe US Pharmacopeia states that parenterals be "essentially free" of visible particulates. Visual inspection systems are used to achieve this. Manual systems are where a human inspector looks for and removes unacceptable units of product. Automated systems utilize automated inspection machines to identify and reject defects due to foreign particulate matter.

For validation of an inspection system, whether it’s automated or human, SoloHill Particle Validation Standard Kits with typical particle sizes of 100 – 4000 µm are designed to replicate nearly all the possible contamination from a pharmaceutical production area.

Particle types include glass shards, fibers and hair, rubber and silicone, plastics of all types, metals such as stainless steel and aluminium, and even customized particles, if needed.

• NIST Traceable • Convenient • Economical

SoloHill Particle Validation Standards are a necessary component of any visual inspection system, and provide a practical solution to achieving high-quality visual inspection of parenterals.

Micro-Volume Label-Free Protein AnalysisThe Pall ForteBio BLItz® system enables scientists with just a few samples and limited sample volume to detect active proteins easily and cost-efficiently. Using only a tiny drop of sample, the system performs fast protein quantification, binding kinetics and affinity analyses of protein interactions in a simple "drop, read, done" format.

• Affinity Studies (Binding Kinetics) • Presence/Absence Studies • Protein Quantification • Assay Development

Analyses require 15 to 20 times less sample compared to label-free SPR or microplate-based ELISA. The system utilizes biolayer interferometry (BLI) to detect small changes in the number of molecules bound to a ready-to-use biosensor. As the binding rate is proportional to the number of molecules, the system provides direct quantification even in crude samples. Assay running is as simple as dipping the biosensor into the sample!

• Quantify proteins or antibodies with only 4 µL of sample in less than a minute • Obtain real-time binding curves in seconds to minutes • Small footprint (comparable to a tablet PC) • Wide choice of biosensors • Affordable price













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bioprocess

visionQuantification, Binding Kinetics and AffinityPall ForteBio’s Octet® RED96 system is a multi-functional, label-free instrument for rapidly quantifying protein concentration and measuring binding kinetics and affinity. It is a faster and more reliable alternative to conventional HPLC, ELISA, SPR and other single-purpose microfluidic-based systems.

The Octet RED96 system relies on biolayer interferometry (BLI) for cutting-edge protein analysis that accelerates and simplifies work with simultaneous analysis of 8 samples and automated assay processing.

Combined with the Anti-CHO HCP Detection Kit, it provides an automated alternative to ELISA that reduces hands-on time, improves data quality and decreases time to results: approximately 90 minutes for 96 samples compared to 210 minutes on ELISA.

Alternative systems are available for higher throughput (e.g. Octet HTX system) or lower throughput (e.g. Octet K2 system, see picture). All systems provide savings in time and labor and improve data quality across the entire bioprocess workflow – from cell line development to process monitoring and quality control.

High-Throughput Detection of Host Cell ProteinThe Pall ForteBio Anti-CHO HCP detection kit is perfectly suitable for generic assays to quantify HCP contaminants from CHO cell cultures, which carry substantial risk of decreasing drug efficacy and drug safety.

Specifically designed for biolayer interferometry (BLI) and with a dynamic range of 0.5 to 200 ng/mL the new kit offers a higher degree of sensitivity, precision, automation, speed and robustness compared to conventional methods (ELISA, MS or Western Blotting). It has been jointly developed with Cygnus Technologies.

Pall ForteBio's high-throughput protein analysis combined with the broad HCP recognition and sensitivity of the industry-standard Cygnus 3G anti-CHO HCP antibody bring scientists the best of both worlds for efficient host cell protein analysis.

The Anti-CHO HCP detection kit used with a Pall ForteBio Octet HTX system provides an automated alternative method to ELISA that eliminates hands-on time, improves data quality and decreases time to analyzed results. One hour for 96 samples on the Octet HTX system compared to 210 minutes on ELISA (Cygnus 3G).

Pall ForteBio Biosensors OverviewLabel-free protein analysis on the Pall ForteBio BLItz system is carried out by sensitive, disposable biosensors. There are 18 different biosensor chemistries available, which are suitable for either kinetics (K), quantification (Q), or both.

Examples of typical ranges (depending on the samples measured and biosensors used):

• Kinetics – KD 0.1 nM – 1 µM • Quantification – 0.5 - 1,000 µg/mL













29

11

Sensor Description Type

AHC Anti-Human Fc-Capture K

AMC Anti-Mouse Fc-Capture K

APS Amino-Propyl-Silane K

AR2G Amine Reactive 2G K

SA Streptavidin K

SSA Super Streptavidin K

AHQ Anti-Human IgG Fc Q

AMQ Anti-Mouse IgG Fv Q

HIS2 Anti-HIS Q

ProA Protein A Q

ProG Protein G Q

ProL Protein L Q

FAB Anti-Human Fab-CH1 Q / K

FLG Anti-FLAG Q / K

GST Anti-GST Q / K

NTA Ni-NTA Q / K

HIS1K Anti-Penta-HIS Q / K

SAX High-Precision Streptavidin Q / K

www.fortebio.com/octet-platform.html

www.fortebio.com/anti-cho-hcp-detection-kit.html

http://www.fortebio.com/biosensor-types.html

bioprocess

vision

Corporate HeadquartersPort Washington, NY, USA+1 800 717 7255 toll free (USA)+1 516 484 5400 [email protected] e-mail

European HeadquartersFribourg, Switzerland+41 (0)26 350 53 00 [email protected] e-mail

Asia-Pacific HeadquartersSingapore+65 6389 6500 [email protected] e-mail

Visit us on the Web at www.pall.com/biopharmE-mail us at [email protected]

International Offices

Pall Corporation has offices and plants throughout the world in locations such as: Argentina, Australia, Austria, Belgium, Brazil, Canada, China, France, Germany, India, Indonesia, Ireland, Italy, Japan, Korea, Malaysia, Mexico, the Netherlands, New Zealand, Norway, Poland, Puerto Rico, Russia, Singapore, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, the United Kingdom, the United States, and Venezuela. Distributors in all major industrial areas of the world. To locate the Pall office or distributor nearest you, visit www.pall.com/contact.

The information provided in this literature was reviewed for accuracy at the time of publication. Product data may be subject to change without notice. For current information consult your local Pall distributor or contact Pall directly.

© 2015, Pall Corporation. Pall, , Acroprep, Allegro, BLItz, Cadence, Emflon, Hillex, iCELLis, Kleenpak, LevMixer, Mustang, Newform, Octet, Omega, Palltronic, Pegasus, Resolute, Seitz, SoloHill, Stax, Supor are trademarks of Pall Corporation. ® indicates a trademark registered in the USA and TM indicates a common law trademark. Filtration.Separation.Solution is a service mark of Pall Corporation.

Robocolumns is a trademark of Atoll GmbH.

3/15, PDF, GN15.6229_EN

ACHEMA Congress 2015Seven Reasons to Have a Closer LookPall Life Sciences will give a series of technical presentations at Achema Congress 2015. The program features more than 500 lectures, which will provide an extensive survey of topical trends. We are happy to welcome you for these sessions and subsequent discussions on our booth, where you will be able to meet all presenters.

Analytical Techniques for Process Characterization and MonitoringLabel-free Protein Analysis in DSP

Advances in label-free techniques for rapid characterization of downstream bioproces-ses: determination of protein concentration, protein/ligand binding kinetics, residual Protein A, and host cell protein contaminant analysis.

Hendrik Wünsche, Pall Life Sciences

16.06.2015, 15:00, CMF, Room Fantasie 1

Scaling-up Stem Cell ManufacturingHigh Productivity Manufacturing Technology

Cell therapies gear up to have extensive impact on healthcare. Methods to grow adherent stem cells at large scale are needed. Case studies illustrate strategies for transition from traditional lab scale to large GMP production.

Thierry Bovy, Pall Life Sciences

17.06.2015, 11:10, Hall 3 VIA West, Room Facette

Single-Use Systems Integrity TestingA Practical Approach

Pall Life Sciences developed a method that can be easily applied for point-of-use testing of complex single-use systems. Approaches to test such systems without breaching sterility will be presented.

Hélène Pora, Pall Life Sciences

17.06.2015, 12:50, Hall 3 VIA West, Room Facette

CHO Cell Cultivation in a Non-Cylindrical Stirred Tank BioreactorThe Allegro STR 1000 Single-Use Bioreactor

The unusual shape of the Allegro STR single-use bioreactors has a positive influence on the mixing performance, while cell growth and viability are comparable to cylindrical stirred tank reactors.

Michael Kradolfer, Pall Life Sciences

18.06.2015, 11:00, CMF, Room Illusion 2

Virus Production from Bench Scale to Industrial ScaleSingle-Use Fixed-Bed Bioreactor

A number of viruses for use as vaccines, gene therapy vectors or oncolytics have been produced in iCELLis bioreactors. Results indicate that these bioreactors are a suitable platform for industrial scale adherent cell cultures.

Pascal Lefebvre, Pall Life Sciences

18.06.2015, 11:30, CMF, Room Illusion 2

Integrated Single-use TFF Solutions for DSPFrom R&D to Commercial Manufacturing

Benefits of ready-to-use single-use tangential flow filtration solutions with Allegro systems integrating Cadence TFF modules: ease-of-use, process reliability, operator safety, containment and cost reduction versus reusable TFF.

Nathalie Pathier, Pall Life Sciences

19.06.2015, 11:50, Hall 4.2, Room Brillianz

A Single-use Clinical Scale Filling SystemFrom Design to Delivery

Merck Sharp and Dohme partnered with Pall Life Sciences and Bausch+Stroebel to design single-use technologies on a filling line to support clinical material production. Key was to use a fully disposable fluid path.

James Barry, Pall Life Sciences

19.06.2015, 12:50, Hall 4.2, Room Brillianz

You are invited to join us for a free demonstration of the installation of the single-use system into our Allegro STR 1000 Single-Use Bioreactor:




Further Information. 30

-Special

Allegro STR 1000 Single-Use

Bioreactor Demo

Pall Life Sciences, Hall 6.0, C74

Daily at 3 pm

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

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