USD2472(1) - Pall Allegro Systems

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USD 2472(1)

Pall Allegro™Systems The Single-use Solution for Manufacturing of Biopharmaceuticals 2AllegroSystems

TheSingle-Use Solution

™www.pall.com3

Single-use disposable technology is a proven alternativesolution for the biopharmaceutical industry offering severalsignificant advantages over standard reusable stainless steelsystems, by reducing:

uCross contamination risk uCleaning and associated cleaning validation uCapital investment uLead times uThe number of connections to enhance sterility assurance

Furthermore, in applications where hazardous materials arebeing processed, such as cytotoxic drugs or potentbiological materials, closed disposable systems offeradditional protection to operators who are isolated fromthese hazards.

Pall Allegro Systems Benefits of single-use systems uFlexibilityuTechnology available at multiple scales uCost effective manufacturing technology uSuited for all biopharmaceutical processes Why work with the Pall Allegro systems team

uUnparalleled process knowledge uSignificant experience with single-use systems uUnique product portfolio uExcellence in technical support uFull documentation package

Reduce production cycle times

Greater assuranceof sterility

Reduce capital investment infacility & equipment

Reduce time to getfacility up and running

Eliminate cleaning requirements

Decrease risk of cross-contamination

Reasons for Increasing Use of Single-Use / Disposable System Components

Reference: Report and Survey of Biopharmaceutical Manufacturing Capacity & Production, Fourth Annual, June 2006, BioPlan Associates

The Single-use Solution for Manufacturing of Biopharmaceuticals42

..... Into Simple Solutions

We Turn Complex Systems.....www.pall.com5

Benefits of Pall Allegro SystemsWhile the cost of consumables may be higher, the use of Pall Allegro systems can reduce your overall manufacturingcosts by enabling:

uDrastic reduction in chemicals and WFI consumption uLower energy costs through use of Gamma sterilized components

uDecreased labor with no cleaning and cleaning validations, faster installations and limited QC testing

uSmaller space requirements for manufacturingFlexibility Pall Allegro systems provide a high degree of flexibility foryour process design. They allow you to easily evaluatedifferent configurations before agreeing on the final design.Then, should your batch size be modified, or yourrequirements evolve, your systems can be easily tailored tofit with your new requirements.

Our technology is applicable to a wide range of unitoperations. There will always be at least one step of yourprocess that can benefit from single-use technology.

Technology available at all multiple scales

Pall Allegro systems can be used at many scales, from themanufacturing of small clinical batches to full productionscale. Most components are now available at all scales:from capsule filters to chromatography capsules, bags, and all related equipment.

With consistent materials of construction from small to largescale, single-use systems are ideal for scaling up or scalingdown your process.

Speed of implementation and time to market

Pall Allegro systems can be developed and implementedin weeks rather than months. Because of the reducedrequirements for validation (including cleaning & steriliza-tion) and the ease of manufacturing, process steps canbe developed very quickly.

Single-use technology will help you speed up your processdevelopment and installation of manufacturing process line,therefore reducing time to market.

A Cost Effective Manufacturing Technology 62

Why Choose Pall Allegro Systems Pall Allegro systems can be used to manufacture of alltypes of drugs: monoclonal antibodies, vaccines, genetherapy, recombinant proteins, blood derivatives and anti-cancer drugs. They are particularly well suited forContract Manufacturing Organisations, where a number of different products will be produced and the key issuesare flexibility and avoiding cross contamination.

Single-use technology can be applied from Upstreamthrough Downstream and Formulation and Filling.

Suited for all Biopharmaceutical Processes