Manufacturing And Sustainability

  1. Animal Testing & Tox: What's Required Today? 2/21/2023

    In this segment of the Bioprocess Online Live event IND Success: Navigate Through The Regulatory Gray, Umoja Biopharma VP of Regulatory Affairs Heln Kim entertains audience questions on FDA toxicology and animal study requirements in light of the Reducing Animal Testing Act passed in December, 2022.

  2. Quality Roundtable: Optimizing Biologics Manufacturing Processes With Raw Materials 1/24/2024

    Improve your commercial manufacturing process with advice from regulatory and raw materials experts on the development journey from pre-clinical to licensure.

  3. Accelerate Process Development With HTS Chromatography Tools 7/16/2024

    High Throughput Screening (HTS) chromatography tools can accelerate process development and reduce material usage. Learn about a solution that addresses challenges with their use in new modalities.

  4. 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.

  5. Upstream To Downstream: A Comprehensive Approach To AAV Production 12/7/2023

    How can you face the challenges of AAV production, scale up your AAV manufacturing effectively, and enhance the recovery and purity in your downstream processing.

  6. An Advanced Single-Use Solution for Downstream Bioprocessing 9/5/2023

    A single-use chromatography system is offering an innovative solution tailored to meet the needs of evolving downstream purification bioprocesses.

  7. Rapid Process Development And Technical Support For AAV Scaleup 12/17/2024

    Accelerate your AAV production journey. Learn how rapid process development and expert support can streamline your path from vial to purified bulk, ensuring scalable and efficient manufacturing.

  8. 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.

  9. So, You've Been Put On Clinical Hold… 2/21/2023

    As the frequency of clinical holds increases, so do the chances it’ll happen to you. What’s a biopharma leader to do if it happens? Umoja Biopharma VP of Regulatory Affairs Helen Kim and NDA Partners Regulatory Affairs Expert Consultant Daniela Drago, Ph.D. offer advice on direct engagement with the FDA to expedite the release of a clinical hold.

  10. The Way Forward: Supply Chain Solutions 10/24/2024

    Learn how to build a resilient supply chain to navigate today's complex environment. Expert speakers share insights on optimization, innovation, and strategic planning to meet evolving market conditions.