DOWNSTREAM PROCESSING WHITE PAPERS & CASE STUDIES

• The Challenge of Measuring Total Organic Carbon In Modern Pharmaceutical Water Systems

  Total Organic Carbon (TOC) is one of the quality attributes defined in the European and USA pharmacopoeias for pharmaceutical waters. Modern water treatment systems can deliver such high purity water that TOC levels can be consistently close to zero and very difficult to measure with any accuracy. This paper discusses some of the challenges when using TOC analysers to demonstrate pharmacopoeial TOC level compliance for modern water systems in the light of the ICH Q2 document from the International Conference on Harmonisation.

• CD69 Expression On Activated Lymphocytes Is Stable In Streck's Cyto-Chex® BCT

  The purpose of this study was to determine if the activation marker, CD69, is preserved and stable in whole blood samples collected in Cyto-Chex® BCT. Previous studies have demonstrated CD marker stability of whole blood samples collected in Cyto-Chex BCT for up to 7 days when stored at room temperature (18-22°C).  By Jodi Alt, Ph.D

• Microbial Fermentation In Single-Use Xcellerex™ XDR-50 MO Fermentor System

  This application note describes the performance of a single-use Xcellerex XDR-50 bioreactor system when used in cultivations of E. coli and of modified Pseudomonas fluorecsens (P. fluorescens) producing a monoclonal antibody (MAb). Both the achieved microbe densities and product yield were shown to be consistent with the performance of conventional stainless steel systems.

• Managing Cell-Based Potency Assays: From Development To Lifecycle Maintenance

  Characterization of a biological product — which includes the determination of physicochemical properties, biological activity, immunochemical properties, purity and impurities — is necessary to establish the safety and efficacy profile of a given product (ICH Q6B).  By Dr. Weihong Wang, manager, Molecular and Cell Biology, Eurofins Lancaster Laboratories

• Monoclonal Antibody Purification Platform Using High-Capacity Protein A And Mixed-Mode Chromatography

  The first step in purification of an important class of therapeutic proteins, the polyclonal or monoclonal antibodies (mAbs), is their capture from plasma or tissue culture supernatants. Protein A–based media are by far the most common class of affinity products used for this purpose.

• Rapid Screening Of A Cell-Based Assay For GLP-1 Receptor Using A Natural Product Library

  Here we demonstrate the detection of GLP-1R binding through the incorporation of a homogeneous cell-based binding assay using HTRF Tag-lite® technology. By Brad Larson and Peter Banks, BioTek Instruments, Inc. and Nicolas Pierre, Suzanne Graham, Jean-Luc Tardieu, and François Degorce, Cisbio US, Inc.