Bioprocessing White Papers

  1. Viral Clearance: The Basics On How To Conduct Effective Studies
    5/17/2019

    Effective viral clearance studies remain one of the challenges facing manufacturers of biologics. These studies are an essential part of process validation and are critical to ensure drug safety. This article provides the basics of what you need to know when studying virus reduction of a chromatography step.

  2. Scalable Production Of AAV Vectors
    4/25/2019

    This article examines some of the currently available schemes used in generating rAAV from suspension cultures, and describes what it takes to achieve scalable rAAV production.

  3. Guidelines To Bring Your Biologic To Market: Are You Prepared?
    4/16/2019

    Are you up to the task of bringing a biologic to market? Do you have a strategy and plan in place? Explore some of the questions to consider in order to map out a successful pathway and avoid pitfalls.

  4. ICH Q12 Updates: Increasing Efficiency Of Post-Approval Changes
    4/2/2019

    Through proper implementation of ICH Q12 tools and enablers, the industry could manage CMC changes effectively under a company’s pharma quality system with less need for oversight prior to implementation.

  5. Developing A Scalable Process For Adenovirus Manufacturing
    4/2/2019

    To address the growing need for speed and efficiency in viral vector manufacturing, GE developed a process for adenovirus manufacturing that not only meets regulatory requirements but is also scalable.

  6. 6 Regulatory Changes Affecting Bioprocessing In China
    4/2/2019

    This article outlines six recent regulatory changes in China intended to protect patient safety as well as reduce regulatory burdens and minimize delays.

  7. A Common Sense Approach To Sustainability In The Biosimilar Business
    4/2/2019

    Through common sense and creative thinking, the industry can discover new ways to achieve success and sustainability in the biosimilar market.

  8. Critical Considerations About The Future Of Global Cell Culture Bioprocessing
    4/2/2019

    In today’s changing industry, it is critical we consider several factors about cell culture bioprocessing and the impact they will have on the future of patient treatment.

  9. The Use Of Cell-Free Synthesis In The Future Of Modern Medicine
    4/2/2019

    Cell-free synthesis systems are well suited to manufacture at the point of treatment, yet there are several challenges transitioning to this more efficient model for the future of medicine.

  10. Sensitive And Reproducible SPR-Based Concentration And Ligand-Binding Analyses
    3/27/2019

    Surface plasmon resonance (SPR) assays are used across the life cycle of a biopharmaceutical, from target identification, through CQA determination, development, and on-going quality control. This article focuses on concentration assays associated with late-stage development and biotherapeutic drug chemical manufacturing and control.