Outsourced Pharma App Notes & Case Studies

  1. Roivant Accelerates Process Development To Speed Orphan Therapy To Market
    11/10/2017

    This case study shares the work of GE’s Fast Trak Services team to help accelerate development of a process for cGMP production of material for toxicology studies.

  2. Embracing Biosimilars, They Are Here To Stay
    10/10/2018

    The biosimilars market is suddenly booming, with established biopharma giants and nimble start-ups all clamoring for a piece of the action. But such steep competition means that only the wise will survive.

  3. Optimization Of Midstream Cell Lysis And Virus Filtration Steps In An Adenovirus Purification Process
    9/10/2018

    Here we describe screening of detergents for release of adenovirus from HEK293 host cells to replace the traditionally used detergent Triton™.

  4. Continuous Chromatography In Downstream Processing Of A mAb
    2/1/2018

    In this study, periodic counter current (PCC) chromatography and straight-through processing (STP) technologies were evaluated in a continuous three-step monoclonal antibody (mAb) purification process.

  5. Automated In-Line Buffer Prep Saves Time And Facility Footprint
    2/1/2018

    Buffer preparation is both time- and space-consuming and become a challenge in biomanufacturing. This application note describes a lean approach to buffer preparation by implementing in-line conditioning.

  6. The Pharma Trends You Need To Know: A CDMO’s Perspective
    10/18/2018

    Companies must understand how today’s new pharmaceutical landscape is causing a dramatic shift in how we plan for and execute drug development and manufacturing.

  7. Strategies for Efficient Clinical Supply Management and Forecasting
    3/6/2018

    Engaging clinical supply management and forecasting adds value by evaluating different response strategies and contingency plans and can identify supply solutions that minimize or even potentially avoid supply chain disruptions.

  8. A Solution To Ensure Quantity & Quality Of The Excipient Polysorbate-80 In Drug Formulations
    6/10/2019

    Polysorbate-80 (PS-80) is a surfactant commonly used as an excipient to improve API stability. However, degradation of PS-80 can lead to decreased drug potency or stability, and there is inconsistency in the quality and composition of PS-80 provided by different vendors.

  9. Bioburden Entry Points In Downstream Processing
    1/29/2018

    Tips to prevent bioburden entry and proliferation, and reduce the complexity of the equipment and processes involved.