White Papers

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

    Are you up to the task of bringing a biologic drug to market? Do you have a strategy and plan for moving forward? Here we explore, from a biopharma process development and manufacturing perspective, some of the questions to consider in order to map out a successful pathway and avoid pitfalls along the way.

  2. Advances In Temperature Calibration Procedures
    4/5/2019

    Recent developments eliminate the need for unnecessary calibrations and speed up the time it takes to do calibrations in the field.

  3. Understanding The Importance Of Punch Length And Cup Depth
    4/4/2019

    Manufacturing tablets to a uniform hardness, weight, and thickness requires tablet press punches of consistent length. This paper describes how to understand punch length, how to measure it correctly, and how wear affects length and tablet consistency. It also addresses the importance of specifying cup-depth tolerances.

  4. ICH Q12 Updates: Increasing Predictability And 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 pharmaceutical quality system with less need for extensive regulatory 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. Venting Fume Hood Base Cabinets – A Better Way
    3/27/2019

    Frequently, customers have used fume hood exhaust to ventilate hood base cabinets. There is both the need for this practice and the designs for them are frequently not well thought-out. Alternate rationales and approaches to this ventilation method are reviewed with clear-cut recommendations in this paper.