Biosimilar White Papers

  1. 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.

  2. Optimizing Process Efficiency In Upstream Manufacturing 2/8/2019

    Increasing the integration of upstream and downstream processing and moving toward increased automation results in greater optimization of process efficiency — a key goal for biopharma production.

  3. 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.

  4. Virus Safety For Continuous Processing 9/5/2019

    Transitioning to a continuous processing approach requires the implementation of an effective virus clearance strategy, which is intended to prevent various virus contaminations that could threaten patient safety.

  5. Scaling A mAb Production Process To A Single-Use Platform 9/27/2019

    The transfer of mAb production processes between scales, referred to as scale-up or scale-down, is difficult. This study reviews moving mAb production from a microscale bioreactor to a single-use platform.

  6. 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.

  7. Utilizing External Collaboration To Accelerate Vaccine Development 11/2/2018

    Securing a partner to serve as an extension of Janssen’s Biotherapeutics Development API-Large Molecule team was essential to reduce both risk and the time needed for delivery of clinical supplies.

  8. 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.

  9. Digital Manufacturing Of Biologics 2/19/2019

    In addition to an explanation of digital manufacturing, this paper covers how it can improve the productivity and robustness of existing processes and facilities. 

  10. 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.