Controlled Nucleation for a Monoclonal Antibody Formulation—A Case Study

Joseph Brower;Eugene Wexler, PhD;

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Analytical Method Development
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Aseptic Processing
Biologic Drugs
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Equipment
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Formulation
Packaging
Process Control/PAT
Process Development
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Regulatory Action
Supply Chain

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Controlled Nucleation for a Monoclonal Antibody Formulation—A Case Study

Published on: May 15, 2015

Joseph Brower, Eugene Wexler, PhD

Pharmaceutical Technology, Pharmaceutical Technology-05-15-2015, Volume 2015 eBook, Issue 2

This study evaluates the impact of controlled nucleation on the ability to optimize a lyophilization cycle for a monoclonal antibody formulation.

This study evaluates the impact of controlled nucleation on the ability to optimize a lyophilization cycle for a monoclonal antibody formulation.

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