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FunctionMAX™ TiterEnhancer Overview

Customer name here Account Manager name here Date

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Have you ever experienced a fed-batch process that…

• made you question if titers were maximized as much as possible?

• you wanted to rework with minimal changes just to improve cost of goods?

• presented a critical challenge: raise titers or stop the project?

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Current options to improve fed-batch outcomes

Approach

Extreme pH

Adding more feed Volume

Adding Exotic Ingredients

Concerns

Employee Safety & Bioreactor Control

Constraints on Total Volume

Regulatory Justification & Product Quality

What to Avoid

Using Extreme pH to Solubilize Ingredients

Large Volume Additions

Undefined Ingredients not found in Base

Media

New Class Solution

Highly Concentrated, pH Neutral Additives

Adding Key Ingredients without Large Volume

Additions

Chemically Defined, Animal Origin-Free,

Protein Free, Additive Containing Base Media

Ingredients

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Introducing Gibco® FunctionMAX™ TiterEnhancer

a revolutionary functional additive for CHO fed-batch processes

What is it?

Your New Class Solution Additive: • Highly concentrated • pH neutral • protein-free • chemically defined • animal origin-free additive

What It Does

• Improves cell productivity • Provides up to double titers • Requires minimal process

changes

Delivering higher concentrations of key ingredients than previously possible

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7x Concentration Key Ingredients vs. Base Media

Benefits of highly concentrated, pH neutral additive

• Easier delivery into culture • No impact on bioreactor pH when added • Avoids extreme pH hazard for technicians • Reduced risk of changes in product quality

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More than 2x Titer Levels Customer Case Study in 5L Bioreactor

Increase in qP

No change in growth

More than double titer levels without

Significant increase in viable cell density

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Addition of FunctionMAX™ TiterEnhancer means

Process Advantage

Just add to current process

Partial replacement of feed possible

Only small addition (10%) needed to quickly see benefit

No exotic ingredients

Only delivers ingredients cells utilize in base medium

Potential Impact

No extensive rework

Avoid modifications to bioreactor working volume to see benefit

Reduced process development time to achieve target titers

Lower regulatory burden

Less explanation to regulators required

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More protein per run

• Offers reduced cost per gram of protein produced

• More capacity made available for other uses or

• Fewer complete reactor cycles (prep, run, clean)

Fewer runs

• Fewer purification cycles

Simple prep & addition with feeds

• Enables reduced prep times

• Minimizes failure risk & related costs

Potential Economic Benefits

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FunctionMAX™ TiterEnhancer Key Benefits

Up to double titers

•Boosts plateau in specific productivity

•Delivers key ingredients needed late in culture

Deliver higher concentrations at neutral pH, enabling

• Easier delivery into culture

• No impact on bioreactor pH

• Avoidance of extreme pH hazards for technicians

• Reduced risk of changes in product quality

Require minimal, if any, process optimization

•Can be added to current process or as partial feed replacement

•Avoids adjustments to bioreactor working volume

•May reduce process development time

•Contributes to lower regulatory compliance risk vs. alternatives

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For Research or Manufacturing Use Not intended for any animal or human therapeutic or diagnostic use

© 2012 Life Technologies Corporation. All rights reserved. The trademarks mentioned herein are the property of Life Technologies Corporation and/or its affiliate(s) or their respective owners.

FunctionMAX™ TiterEnhancer is Available Liquid or AGT™ dry format

Product Quantity Cat. No

Gibco® FunctionMAX™ TiterEnhancer liquid 100 mL bottle A1501001

Gibco® FunctionMAX™ TiterEnhancer liquid 500 mL bottle A1501002

Gibco® FunctionMAX™ TiterEnhancer AGT™ additive 10 L (1500g AGT) A1500901

Gibco® FunctionMAX™ TiterEnhancer AGT™ additive 100L (15000g AGT) A1500902

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Visit the FunctionMAXTM Website

www.lifetechnologies.com/FunctionMAX