Downstream Processing White Papers and Case Studies

  1. USP <787> Small Volume Testing With Liquid Particle Counters

    By their very nature, biological therapeutics are not only expensive to manufacture but are often produced in small volumes.

  2. Important Considerations For Implementing A Single-Use Biomanufacturing Strategy 10/18/2013

    Recent trends in biomanufacturing technology and the biopharmaceutical market are supporting the increased adoption of single-use (SU) manufacturing systems. On the demand-side, the biopharma industry is focusing on niche and rare diseases with smaller patient populations, resulting in the need for smaller, more agile biomanufacturing capacity. By Jodi M. Zobrist and Nicole W. O'Brien, Ph. D., Gallus Biopharmaceuticals, LLC

  3. Rapid Screening Of A Cell-Based Assay For GLP-1 Receptor Using A Natural Product Library 8/9/2012

    Here we demonstrate the detection of GLP-1R binding through the incorporation of a homogeneous cell-based binding assay using HTRF Tag-lite® technology. By Brad Larson and Peter Banks, BioTek Instruments, Inc. and Nicolas Pierre, Suzanne Graham, Jean-Luc Tardieu, and François Degorce, Cisbio US, Inc.

  4. Compound Profiling And Toxicity

    Utilizing a systems approach to drug discovery has generated a multitude of high affinity compounds for various classes of molecular targets with different degrees of disease state validation.

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

    A guide to effectively remove endotoxins with versatile process resins.

  6. 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.

  7. 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

  8. Avoiding Drug Shortages With Microbial Detection 3/6/2013

    Over the past year, critical drug shortages used to treat a host of life-threatening illnesses have been making headlines. Microbial contamination has been cited as a major contributor to the shortage, yet the prevailing practices to ensure the safety of drugs have been slow to change. In most cases, quality assurance practices safeguarding the drug making environment continue to rely on periodic air and a culturing method from a prior century. By Aric Meares, President and CEO, BioVigilant

  9. Improving Aggregate Removal From mAb Feed Using Cation Exchange Chromatography

    Researchers in the field of chromatography have required ever more sophisticated and selective methods for removing aggregates from the monomer.

  10. Biomanufacturing Complexity 12/22/2011

    This white paper addresses one of the most serious challenges facing biomanufacturing professionals today - how to understand and then deal with the extreme complexity associated with biotechnology manufacturing.