LCGC North America-01-01-2020

LCGC North America

Vol 38 No 1 LCGC North America January 2020 Regular Issue PDF

January 01, 2020

LCGC North America, January 2020

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Click the title above to open the LCGC North America January 2020 issue, Volume 38, Number 1, in an interactive PDF format.

A Review of Recent Developments in Analytical Characterization of Glycosylation in Therapeutic Proteins

January 01, 2020

Focus on Biopharmaceutical Analysis

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Advanced separation and mass spectrometry methods enable comprehensive profiling of the inherent glycan heterogeneities of protein therapeutics. In particular, reversed-phase HPLC–based multiattribute methods (MAMs) provide a wealth of information, and other techniques, such as HILIC and CE-MS, also continue to evolve.

The Current Landscape of Data Integrity

January 01, 2020

Focus on Data Handling

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A look at how data integrity requirements and the focus of data integrity have changed over the past five years.

Technical Challenges Encountered During Chromatographic Method Transfers to Pharmaceutical Manufacturing Sites

January 01, 2020

Peer-Reviewed Article

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Drug substance development requires a complex range of analytical methods, presenting a challenge to analytical chemists to reliably transfer and execute these fit-for-purpose methods to external manufacturing sites. Here, we provide guidelines to follow, and share examples of realworld problems and the strategies used to remedy them.