Downstream Processing White Papers and Case Studies

1. A Disposable Valve For Process Chromatography 8/15/2012

   This case study discusses the need for a fully automated, disposable chromatography system which was PLC controlled and designed for use in a cGMP environment. The required applications for the chromatography system included contamination removal, and concentration and purification of biologically derived proteins used in the production of research and clinical materials. 

2. Mammalian Virus Purification Using Ceramic Hydroxyapatite

   Conventional techniques for mammalian virus purification produce variable quality, quantity, and significant loss of particle infectivity. We  propose the chromatographic separation of viral particles of diverse sizes and from different families such as dengue, influenza, mouse hepatitis, adenovirus, poliovirus using CHT Ceramic Hydroxyapatite resin.

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. 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.

5. 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.

6. Turning Data Into Information 12/22/2011

   As biopharmaceutical manufacturing has evolved from small-scale lab production in small flasks to massive commercial production in deep-tank bioreactors, an avalanche of production data has evolved to support it. From individual unit operation skids to distributed control systems and enterprise resource planning tools, biomanufacturing today is buried by the sheer quantity of data coming in from the manufacturing floor.

7. Biomanufacturing Debottlenecking And Process Optimization 3/6/2012

   Optimizing biomanufacturing is particularly challenging because of variability and complexity associated with the sharing of finite and interdependent resources. By BIO-G

8. Improving DNA Removal from Bioprocess Purification Processes

   Many new biological drug products produced using recombinant DNA technology, such as monoclonal antibodies, are produced in cell culture. Because therapeutic proteins such as monoclonal antibodies are produced in cell culture, impurities can result from the host cells, or cell substrates. By 3M Purification Inc.

9. A Purification Strategy For Clinical-Grade Monoclonal Antibody 10/3/2016

   mAbs are currently the most important class of therapeutic proteins. Advances in upstream process technologies have led to tremendous improvement of mAb titers in mammalian cell culture. 

10. 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.