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. SciLog - Creating Advanced Biotech Equipment With Mettler Toledo 3/26/2012
    For nearly two decades, SciLog, Inc. has been dedicated to creating revolutionary single-use purification systems and disposable sensor technologies.
  3. Guidelines For Proper Filtration And Delivery Of Samples To On-Line Process Analyzers 5/25/2012

    Increasingly precise process control strategies, often linked to computer control, have accelerated the use of sophisticated on-line chemical composition analyzers in plant applications. Instruments such as gas and liquid chromatographs, ion chromatographs, laser optic instruments, atomic absorption instruments and specific ion analyzers, which were rarities in laboratories ten years ago, are now found routinely in plant settings. By Ken Perrotta, Division Engineering Manager

  4. 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

  5. Managing Cell-Based Potency Assays: From Development To Lifecycle Maintenance 4/24/2012

    Characterization of a biological product — which includes the determination of physicochemical properties, biological activity, immunochemical properties, purity and impurities — is necessary to establish the safety and efficacy profile of a given product (ICH Q6B).  By Dr. Weihong Wang, manager, Molecular and Cell Biology, Eurofins Lancaster Laboratories

  6. 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

  7. 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

  8. Metal Removal From Fine Chemical Products

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

  9. 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).

  10. 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.