Downstream Processing White Papers and Case Studies

61. Single-Use Connections Advance Aseptic Processing

    John Boehm discusses how single-use connections advance aseptic processing and create increased process flexibility and reliability while reducing costs.

62. 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.

63. 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.

64. 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

65. 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

66. 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

67. Automation Of A Homogeneous Proximity Assay For Detection Of Residual Protein A In Biological Therapeutics

    Protein A is used in affinity chromatography for therapeutic antibody purification and has been shown to leach from columns during purification of antibodies resulting in contamination. Residual Protein A in therapeutic drugs could elicit mitogenic or immunological reactions in patients.

68. White Paper: Computrac® Moisture Analysis Made Simple 8/10/2011
    When people aren’t feeling their best they often turn to medicine for relief from the symptoms that are associated with being ill. The public trusts that the products by pharmaceutical companies will not only make them feel better but will also not have harmful side effects.
69. 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

70. 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.