Downstream Processing White Papers and Case Studies

1. Biomanufacturing Supply Chains 12/22/2011

   This white paper examines the major issues with biopharmaceutical supply chains and how to balance inventory and risk optimally in the network.

2. 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.

3. Gemin X Pharmaceuticals: Finding A Drug's Mechanism Of Action

   Gemin X, a pharmaceutical company focused on the discovery and development of advanced oncology
   therapeutics, approached Metabolon to run a metabolism profile for one of their compounds—GMX1777.

4. Automated Bioluminescent ADCC Reporter Bioassay Using Bioengineered Jurkat Cells 2/10/2013

   Pharmaceutical companies are increasingly exploring new biologic and biosimilar products, and thus increasing monoclonal antibody (mAb) immunotherapeutic research. By Tracy Worzella, Promega Corporation and Brad Larson, Applications Department, BioTek Instruments, Inc.

5. Removal Of Host Cell Proteins During Monoclonal Antibody Purification

   Protein A chromatography is a widely used and highly successful method of purifying recombinant monoclonal antibodies. However, since Protein A has high affinity for antibodies, harsh conditions such as low pH are often required to elute monoclonal antibodies from Protein A affinity columns. By 3M Purification Inc

6. Microbial Fermentation In Single-Use Xcellerex™ XDR-50 MO Fermentor System 10/24/2013

   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.

7. 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.

8. Comparison Of Five Cell Culture Media Demonstrating CHO Cell Culture Growth In Batch Or Fed-Batch Process For Commercial Operations

   This case study details a two month, four phase project to design chemically-defined feed media that improved two simulated batch processes utilizing products by SAFC, Life Technologies, Thermo Fisher Scientific, and Irvine Scientific. By Mark C. Arjona, Evan R. Horowitz, Alex A. Jurisch, Jenny Y. Bang, Tom Fletcher, Irvine Scientific

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. Effect Of Sterilization On Mechanical Properties Of Silicone Rubbers 6/18/2013

    Silicone rubber is widely used in the pharmaceutical industry where sterilizability is an essential requirement for all fluid transfer equipment. Pharmaceutical products must be sterilized frequently and repeatedly by high level energy and/or chemical vapor in order to eliminate bacterial surface contamination.