Downstream Processing White Papers and Case Studies

  1. Quality By Design In Biomanufacturing 12/22/2011

    QbD is increasingly required in our industry, but there are still gaps in understanding how QbD applies to the biomanufacturing process.

  2. Biological Contamination Events In Isolators: What Lessons Can Be Learned? 8/17/2012

    Microbiological deviation and biological contamination events have been observed in pharmaceutical isolators including those used in production, sterility test and pharmacy aseptic services. By James Drinkwater, Bioquell UK Process & Compliance Director

  3. 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

  4. 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.

  5. Rapid Chemically-Defined Feed Media Development to Improve Simulated Cell Culture Processes

    Implementing an optimized feed medium may be the most effective alternative for modifications to the growth medium in an existing process.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. Efficiencies Of Natural Convection In Passive Pallet Shippers

    Bulk transportation of temperature sensitive pharmaceuticals and biologics has become a common practice due to complex global supply chains. By Iftekhar Ahmed, Ben VanderPlas, and Stu Krupnick