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3/8/2017 1
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