Downstream Processing White Papers and Case Studies

  1. Selecting The Optimal Resins For The Process Purification Of Native And Recombinant Proteins 8/3/2016

    Native and recombinant proteins are used in a variety of applications ranging from drug discovery to target validation to high-throughput screening. Due to this, large-scale protein production and purification have become major necessities in industrial settings.

  2. 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.

  3. Important Parameters For Packing Nuvia HR-S Resin At Process Scale 5/27/2020

    Process-scale production typically involves more than one column. The packing quality of each column affects the efficiency of the whole workflow and is an important validation criterion.

  4. 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. 

  5. Single-Use Connections Advance Aseptic Processing

    John Boehm discusses how single-use connections advance aseptic processing and create increased process flexibility and reliability while reducing costs.

  6. Materials Of Construction For Biopharmaceutical Water Systems 1/15/2013

    Stainless steels are uniquely qualified for bioprocessing applications not only because of their long service life, availability, and fabricability, but also because they are non-corroding, non-contaminant, can be polished to very smooth finishes, are strong and rigid, can withstand heat and chemical sterilization treatments, and are easily welded. By Michelle M. Gonzalez

  7. 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

  8. Optimized Sterile Filtration of Pharmaceutical Solutions 11/12/2015

    The cost of filtration and separation stages within the production of pharmaceuticals has been increasing along with the increased complexity of final drug products.

  9. Selecting The Optimal Resins For Endotoxin Depletion In Process Purification 8/3/2016

    A guide to effectively remove endotoxins with versatile process resins.

  10. 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