Downstream Processing White Papers and Case Studies

  1. White Paper: Economic Analysis Of Single-Use Tangential Flow Filtration For Biopharmaceutical Applications 6/10/2011
    Prior to creating an accurate economic model for TFF, a thorough understanding of the process where the TFF is used is needed. A process model is a valuable tool when properly executed and it must accurately include all critical aspects of the purification process. By Michael LaBreck, Mark Perreault, Novasep
  2. Economic Analysis Of Single-Use Tangential Flow Filtration For Biopharmaceutical Applications 6/10/2011
    Prior to creating an accurate economic model for TFF, a thorough understanding of the process where the TFF is used is needed. A process model is a valuable tool when properly executed and it must accurately include all critical aspects of the purification process. By Michael LaBreck, Mark Perreault, Novasep
  3. SciLog - Creating Advanced Biotech Equipment With Mettler Toledo 3/26/2012
    For nearly two decades, SciLog, Inc. has been dedicated to creating revolutionary single-use purification systems and disposable sensor technologies.
  4. Continuous Harvesting Of Extra-Cellular Proteins From Mammalian Cell Cultures Utilizing Small-Scale Perfusion 3/26/2012

    The use of a small-scale cell culture system not only maximizes the production of valuable protein but also avoids the high capital cost associated with system scale-up. Continuous harvesting can provide significant improvements in protein yields when compared to those of typical batch operations.

  5. 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.

  6. Sani-Tech® Ultra White Paper 6/29/2012

    For several years, pharmaceutical manufacturing professionals have increasingly stated concerns about material leachables and extractables and their impact on the products they produce. Fluid transfer systems that include flexible tubing have been at the forefront of this discussion. 

  7. Biomanufacturing Flexibility 12/22/2011

    This white paper from BIO-G looks at how to create flexible, agile manufacturing facilities to respond to the current glut of biomanufacturing capacity and industry consolidation. Future proofing these facilities for higher titers and multiple product lines is also explored.

  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. Examining Column Reproducibility During Method Development In Clinical Labs 6/28/2022

    In this study demonstrates how the HSS T3 stationary phase is a reliable stationary phase, as three batches made over a five-year span provide comparable results.

  10. 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.