Downstream Processing White Papers and Case Studies

1. Top 10 Considerations When Selecting An Isolator Supplier

   While price is certainly an important reason for buying any piece of capital equipment, it is not always the top reason. There are important considerations to examine when selecting an isolator supplier.

2. Determination Of kLa Values Of Single-Use Bioreactors 8/3/2016

   Because single use bioreactors offered by  manufacturers vary in parameters critical for oxygen transfer, they are often not comparable to each other and to conventional glass and stainless steel vessels.

3. Managing Cell-Based Potency Assays: From Development To Lifecycle Maintenance 4/24/2012

   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

4. Automation Of A Homogeneous Proximity Assay For Detection Of Residual Protein A In Biological Therapeutics

   Protein A is used in affinity chromatography for therapeutic antibody purification and has been shown to leach from columns during purification of antibodies resulting in contamination. Residual Protein A in therapeutic drugs could elicit mitogenic or immunological reactions in patients.

5. White Paper: Capillary Electrophoresis — A Simple Technique

   In 1989, Beckman Instruments introduced the first fully automated capillary electrophoresis instrument (P/ACE™ 2000) to the scientific community. At that time, CE demonstrated exceptional resolving of selected compounds, but the new technology lacked a track record of applications. By Beckman Coulter, Inc.

6. Monoclonal Antibody Purification Platform Using High-Capacity Protein A And Mixed-Mode Chromatography 10/1/2016

   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.

7. USP <787> Small Volume Testing With Liquid Particle Counters

   By their very nature, biological therapeutics are not only expensive to manufacture but are often produced in small volumes.

8. An Automated Profiling Application For G9a Histone Methyltransferase And Bromodomain Proteins

   Due to several findings, G9a and BET bromodomain proteins have become the target for numberous drug discovery projects. In this study, we describe a novel, cell-based assay platform that uses the robust, yet simple Enzyme Fragment Complementation (EFC) Technology.

9. CD69 Expression On Activated Lymphocytes Is Stable In Streck's Cyto-Chex® BCT 7/16/2012

   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

10. Guidelines For Proper Filtration And Delivery Of Samples To On-Line Process Analyzers 5/25/2012

    Increasingly precise process control strategies, often linked to computer control, have accelerated the use of sophisticated on-line chemical composition analyzers in plant applications. Instruments such as gas and liquid chromatographs, ion chromatographs, laser optic instruments, atomic absorption instruments and specific ion analyzers, which were rarities in laboratories ten years ago, are now found routinely in plant settings. By Ken Perrotta, Division Engineering Manager