Case Studies in the Development of Drug Substance Control Strategies

A series of case histories from IQ consortium member companies are presented in order to exemplify many of the different elements of drug substance control strategies that are required in order to ensure process performance and product quality. Control through process, method, and/or model design ca...

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Published inOrganic process research & development Vol. 19; no. 8; pp. 935 - 948
Main Authors Thomson, Nicholas M, Singer, Robert, Seibert, Kevin D, Luciani, Carla V, Srivastava, Sushil, Kiesman, William F, Irdam, Erwin A, Lepore, John V, Schenck, Luke
Format Journal Article
LanguageEnglish
Published American Chemical Society 21.08.2015
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Abstract A series of case histories from IQ consortium member companies are presented in order to exemplify many of the different elements of drug substance control strategies that are required in order to ensure process performance and product quality. Control through process, method, and/or model design can combine to form a holistic control strategy that effectively manages risk and assures quality for the patient. A typical drug substance control strategy overview is presented, along with a number of detailed case histories that aim to demonstrate the use of process design and the development of methods and modeling to ensure control of critical quality attributes where appropriate, whether in the final drug substance or through upstream controls.
AbstractList A series of case histories from IQ consortium member companies are presented in order to exemplify many of the different elements of drug substance control strategies that are required in order to ensure process performance and product quality. Control through process, method, and/or model design can combine to form a holistic control strategy that effectively manages risk and assures quality for the patient. A typical drug substance control strategy overview is presented, along with a number of detailed case histories that aim to demonstrate the use of process design and the development of methods and modeling to ensure control of critical quality attributes where appropriate, whether in the final drug substance or through upstream controls.
Author Seibert, Kevin D
Irdam, Erwin A
Schenck, Luke
Srivastava, Sushil
Singer, Robert
Luciani, Carla V
Kiesman, William F
Thomson, Nicholas M
Lepore, John V
AuthorAffiliation Eli Lilly and Co
Biogen
Chemical Development
Pfizer Inc
Small Molecule Design and Development
Chemical Process Research and Development
Chemical Process Development and Commercialization
Bristol-Myers Squibb Company
Merck
Chemical Research and Development
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