Manufacturing And Sustainability

  1. Outsourcing Considerations For Novel Protein Therapeutics 9/13/2024

    Panelists discuss special considerations for outsourcing the development and manufacturing of novel, complex protein therapeutics in this Bioprocess Online Live event.

  2. Process Intensification Development Challenges At AZ and AbbVie 8/27/2024

    In this segment of the Bioprocess Online Live event Bioprocess Intensification In The Real World, panelists respond to audience questions about the challenges they’ve encountered while developing process intensification strategies.

  3. mAb Up- And Downstream Process Intensification Strategies 12/12/2024

    Discover how to reduce monoclonal antibody (mAb) manufacturing time and costs through process intensification. Learn about continuous perfusion, ultrahigh cell density banks, and more.

  4. The Technology Debate: Single-Use vs. Stainless Steel 10/4/2023

    In this discussion you will explore the multi-point case for adopting single-use technologies throughout the workflow via an economic, operational, and environmental sustainability lens.

  5. IND Prep Versus Clinical/Commercial Scale-Up In Novel Protein Therapeutics 9/13/2024

    In this segment of the Bioprocess Online Live event Early Process Considerations For Novel Protein Therapeutics, panelists share detailed considerations for scale-up of complex protein therapeutics.

  6. Where Process Intensification Sits In The AbbVie, AstraZeneca Organizations 8/27/2024

    In this segment of the Bioprocess Online Live event Bioprocess Intensification In The Real World, panelists discuss where and how their roles in setting the course for process intensification sit within their greater organizations.

  7. IND Submissions Are On The Rise 2/21/2023

    During this segment of the Bioprocess Online Live event IND Success: Navigate Through The Regulatory Gray, we asked our live audience about their near-term IND submission plans. Our panelists, NDA Partners Regulatory Affairs Expert Consultant Daniela Drago, Ph.D. and Umoja Biopharma VP of Regulatory Affairs Helen Kim, reflected on the uptick in submissions to the FDA in recent years and prognosticated on the trend.

  8. Why Clinical Holds Happen 2/21/2023

    The volume of clinical holds doled out by the FDA has skyrocketed in recent years. In this segment of the Bioprocess Online Live event IND Success: Navigate Through The Regulatory Gray, NDA Partners Expert Consultant Daniela Drago, Ph.D. and Umoja Biopharma VP of Regulatory Affairs Helen Kim explain clinical holds and discuss why they happen.

  9. Addressing Post-Translational Modifications In Novel Protein Therapeutics 9/13/2024

    Meinhard Hasslacher, Ph.D., Head of CMC at SOTIO Biotech, addresses an audience question on conjugation efficiencies in this segment of the Bioprocess Online Live event Early Process Considerations For Novel Protein Therapeutics. From there, we move on to an audience-led discussion on when to initially address titer, PTMS, and product quality during development of novel protein therapeutic cell lines, with Lena Tholen, Ph.D, Director of Cell Line and Bioprocess Development at FyoniBio and Neeraj Pakala, Ph.D. SVP of Product Development and Manufacturing at Vera Therapeutics weighing in.

  10. How To Avoid A Clinical Hold 2/21/2023

    Umoja Biopharma's VP of Regulatory Affairs and an NDA Partners Regulatory Affairs Expert Consultant have come together to dig into how biopharmas can avoid clinical holds from the outset