Identification and Quantification of Trace-Level Protein Impurities
The authors discuss the development of a simple, sensitive, and universal platform for identification and quantification of trace-level protein impurities in biotherapeutics.
The authors discuss the development of a simple, sensitive, and universal platform for identification and quantification of trace-level protein impurities in biotherapeutics. IgG monoclonal antibody spiked with low abundant proteins was used as the model to test the assay sensitivity and dynamic range. The simultaneous qualitative and quantitative analysis of low abundance proteins was achieved with single injection on a hybrid quadrupole-Orbitrap mass spectrometer.
This LC–MS based approach can be applied for host-cell proteins generated during drug process development by recombinant DNA technology.
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Pharmaceutical Technology’s 2013 Analytical and Bioanalytical Testing ebook.
Specification Equivalence—A Practical Approach
December 30th 2024In this first of a four-part series, the authors provide an introduction to a practical approach for establishing specification equivalence. The regulatory basis and compliance examples from FDA observations and warning letters are included to support the need for an effective process.
Drug Solutions Podcast: Applying Appropriate Analytics to Drug Development
March 26th 2024In this episode of the Drug Solutions Podcast, Jan Bekker, Vice President of Business Development, Commercial and Technical Operations at BioCina, discusses the latest analytical tools and their applications in the drug development market.
