Downstream Processing White Papers and Case Studies

  1. Metal Removal From Fine Chemical Products

    Metal contamination in various injectable or even oral medicines is a serious concern.

  2. Cultivation Of Human CAP Cells: Evaluation Of Scale-Down Capabilities 4/18/2016

    The following application note illustrates how the DASbox Mini Bioreactor System combined with the BioBLU 0.3c single-use vessels supports bioprocess development in human cell culture.

  3. Removal Of Host Cell Proteins During Monoclonal Antibody Purification

    Protein A chromatography is a widely used and highly successful method of purifying recombinant monoclonal antibodies. However, since Protein A has high affinity for antibodies, harsh conditions such as low pH are often required to elute monoclonal antibodies from Protein A affinity columns. By 3M Purification Inc

  4. 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

  5. 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.

  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. 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.

  8. 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
  9. Met One Sensors Resistant To Vaporous Hydrogen Peroxide (VHP) 1/11/2012
    Pharmaceutical manufacturers often require an aseptic production environment to minimize the presence of microbes and their potential contamination of the manufactured product.
  10. 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.