Downstream Processing White Papers and Case Studies

  1. The Challenge of Measuring Total Organic Carbon In Modern Pharmaceutical Water Systems

    Total Organic Carbon (TOC) is one of the quality attributes defined in the European and USA pharmacopoeias for pharmaceutical waters. Modern water treatment systems can deliver such high purity water that TOC levels can be consistently close to zero and very difficult to measure with any accuracy. This paper discusses some of the challenges when using TOC analysers to demonstrate pharmacopoeial TOC level compliance for modern water systems in the light of the ICH Q2 document from the International Conference on Harmonisation.

  2. 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.

  3. Biomanufacturing Supply Chains 12/22/2011

    This white paper examines the major issues with biopharmaceutical supply chains and how to balance inventory and risk optimally in the network.

  4. 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
  5. 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
  6. Proven Long Life Lasers™ In Optical Particle Counters 12/1/2011
    Optical particle counters (OPC) utilize light illumination and extinction to determine the presence, size, number and/or concentration of particles. Particles are typically suspended in a fluid or air, which flow through the volume that is illuminated and viewed by the detection system.
  7. 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.

  8. Connection Technology Advances Closed System Processing

    The global demand for new biologics and vaccines, combined with the growing emergence of biosimiliars, is challenging drugmakers to re-evaluate their processes and seek ways to make them more flexible, reliable, and cost-effective. By John Boehm, Colder Products Company

  9. Applications And Integration Of Hydrogen Peroxide Vapor For Biotech/Bioprocess

    The increase in size and scale of bio-processing is presenting a new challenge. Traditional methods of sterilisation, to maintain clean facilities, are becoming difficult to deploy in a controlled and regulatory compliant way. By Richard Lucas, Ph.D., Bioquell UK Ltd.

  10. 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.