BioPharm International Supplements, February 2007 - BioPharm International

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BioPharm International Supplements, February 2007
Articles
VALIDATION: Advances in the Validation of Chromatographic Processes
By Gail Sofer , Mattias Ahnfelt
ABSTRACT
ALTERNATIVES TO PROTEIN A: Improved Downstream Process Design for Human Monoclonal Antibody Production
By Alahari Arunakumari, PhD , Jue (Michelle) Wang, PhD , Gisela Ferreira
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.
ON-LINE PROCESS CONTROL: Automating the Control of Process-Scale Purification Columns Using On-Line Liquid Chromatography
By Rick E. Cooley
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.
INTRODUCTION: Advances in Process Chromatography The past, present, and possible future of process-scale chromatography
By Uwe Gottschalk, PhD
These articles encapsulate the past, present, and possible future of process-scale chromatography in biopharmaceutical production.
CONTINUOUS PROCESSING: The Multicolumn Countercurrent Solvent Gradient Purification Process
By Guido Ströhlein , Lars Aumann , Thomas Müller-Späth , Abhijit Tarafder , Massimo Morbidelli, PhD
This article presents the multicolumn countercurrent solvent gradient purification (MCSGP) process, which uses three chromatographic columns, and incorporates the principle of countercurrent operation and the possibility of using solvent gradients. A MCSGP prototype has been built using commercial chromatographic equipment. The application of this prototype for purifying a MAb from a clarified cell culture supernatant using only a commercial, preparative cation exchange resin shows that the MCSGP process can result in purities and yields comparable to those of purification using Protein A.

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