Downstream Processing White Papers and Case Studies

  1. 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.
  2. 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

  3. White Paper: Comparability Of The Cell-Freeze® (Charter Medical) Freezing Bag To The Cryocyte™ (Baxter) Bag For Cryogenic Storage Of Human Hematopoietic Progenitor Cells 7/11/2011
    Successful cryopreservation of hematopoietic progenitor cells (HPC) is dependent upon a number of factors, including the biopreservation media, freezing rates, and storage using sterile, cryogenically durable storage bags. The Cell-Freeze® cryogenic storage containers are 510(k) cleared for storage, preservation and transfer of hematopoietic progenitor stem cells (HPC’s). By Charter Medical, Ltd.
  4. How CHT Ceramic Hydroxyapatite Works Application Note 9/30/2016

    CHT ceramic hydroxyapatite is a versatile chromatography support used for separation of biological molecules as diverse as polyclonal and monoclonal antibodies, antibody fragments, enzymes, nucleic acids, and membrane proteins. By Paul Ng, Jie He, and Andrew Cohen, Bio-Rad Laboratories, Inc., Hercules, CA 94547

  5. Best Practices For Process Scale Column Packing Of CHT™ Ceramic Hydroxyapatite Media

    CHT ceramic hydroxyapatite media require specific considerations during process-scale chromatography packing due to high specific gravity, rapid settling rate, and sensitivity to mechanical shear.

  6. 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.

  7. Optimized Purity And Recovery Of A Monoclonal Antibody Using Mixed-Mode Chromatography Media 10/3/2016

    Monoclonal antibodies (mAbs) remain a predominant class of therapeutic protein products on the market because of their wide range of applications in disease treatment and diagnosis. Over the years, upstream technology advancements have helped improve the titer of target antibodies, from merely 1 g/L two decades ago to 10–13 g/L in fed-batch processes and up to 25 g/L in perfusion cultures today (Gronemeyer et al. 2014).

  8. Micro-Volume Determination Of Labeling Efficiency In A Standard Microplate Reader 2/12/2013

    A variety of methods and reagents have been developed to efficiently label biomolecules. By Peter J. Brescia, Applications Scientist,  BioTek Instruments, Inc.

  9. Gemin X Pharmaceuticals: Finding A Drug's Mechanism Of Action

    Gemin X, a pharmaceutical company focused on the discovery and development of advanced oncology
    therapeutics, approached Metabolon to run a metabolism profile for one of their compounds—GMX1777.

  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.