Process Analytical Technologies in Biopharmaceutical Process Development

Application of Proteomics Technologies in the Drug Development Process

Application of Proteomics Technologies in the Drug Development Process

Fluorescence-based tools to improve biopharmaceutical process development

Background Process optimization and control are essential to match biopharmaceutical market demands. Early-steps in the development of new processes require screening hundreds of transfected clones in order to select those with the best expression characteristics, and identifying optimal environmental conditions for these clones to grow and express the protein of interest. While some culture sy...

application of proteomics technologies in the drug development process

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New Challenges for Biopharmaceutical Process Development.PDF

The U.S. Food and Drug Administration (FDA), through the Center for Biologics Evaluation and Research (CBER)/Center for Drug Evaluation and Research (CDER), has long identified that the development of biopharmaceutical products is becoming increasingly challenging, and is inefficient and costly. The agency has also commented that superior product-development sciences are needed to address the c...