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Abstract
An excerpted version of this review paper by Larry R. Brown appears in BPI's 5th-anniversary supplement "Snapshots of an Industry in Motion," which was published in October 2006. As a courtesy to readers interested in more detail, the original version can be downloaded here. It first appeared as "Commercial Challenges of Protein Drug Delivery" in the T&F Informa journal Expert Opinion in Drug Delivery, volume 2, number 1, on pages 29-42.
In vaccine development and manufacturing, GE Healthcare provides a suite of scalable solutions from cell culture through purification to analysis, which offer flexibility and economy, improve purity and secure quality.
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Microcarriers and disposable bioreactors for MDCK and Vero cell culture
Secure cell propagation with adherent cells at reduced cost and with increased flexibility
DNA removal from influenza virus culture
HTPD and DoE for development and optimization of a chromatography step for the removal of host cell derived genomic DNA
Practical Considerations for DoE Implementation in Quality By Design
Contractor Responsibilities in Outsourced Pharmaceutical Quality Control Testing
Measuring Manufacturing Cost and Its Impact on Organizations
Single-Use Technology
Fluorescence-Activated Cell Sorting for CGMP Processing of Therapeutic Cells
The Roles of Bioactivity Assays in Lot Release and Stability Testing