Biopharmaceutical Analysis

Feb 01, 2008
BioPharm International
By BioPharm International Editors
Both innovator and generics companies are using analytics to support comparability arguments.
Jan 01, 2008
BioPharm International
By BioPharm International Editors
Design space concepts are key to a successful technology transfer.
Dec 01, 2007
BioPharm International
By BioPharm International Editors
How the authors used design of experiments and quality by design principles to develop a hydrophobic interaction chromatography step.
Nov 01, 2007
BioPharm International
Contrary to popular belief, the out-of-specification problem started years before the Barr Decision.
Aug 02, 2007
BioPharm International
With the advent of high-resolution mass spectrometers and highly sensitive MS instruments, vaccine characterization has entered a new phase.
Apr 01, 2007
BioPharm International
Process monitoring ensures that the process performs within the defined acceptable variability that served as the basis for the filed design space.
Feb 02, 2007
BioPharm International
Affinity purification schemes for antibody production have certain limitations keeping up with cell culture expression levels as they reach and exceed 10 g/L. New downstream purification processes are based on low cost, long lasting, and high binding (40–100 mg/mL) cation exchange resins.
Feb 02, 2007
BioPharm International
By BioPharm International Editors
This article discusses how on-line high-performance liquid chromatography (HPLC) can measure product purity in the column eluent stream in near–real time. These data can then enable the automation and control of a purification column operation, thus reducing product variability, shortening process cycle time, and increasing yield. An example application demonstrates how on-line HPLC is used as a process analytical technology to ensure the process can accommodate variability in the separation while ensuring the product meets its critical quality attributes.
Feb 02, 2007
BioPharm International
These articles encapsulate the past, present, and possible future of process-scale chromatography in biopharmaceutical production.
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