Manufacturing And Sustainability

  1. A Straightforward Path Toward Regulatory Compliance, Data Integrity, And Computer Systems Validation 6/9/2025

    Learn practical strategies for validating microbial identification systems in cGMP. Understand regulatory guidance and master a complete Computer Systems Validation plan for full compliance.

  2. 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

  3. Advancing Vaccine Development With Novel Chromatography Solutions & Quality Testing 6/24/2025

    Learn more on novel chromatography solutions that can help improve the downstream processes of different vaccine types such as mRNA, recombinant proteins, and Virus-Like Particles (VLPs).

  4. 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.

  5. Interview With Nico Chow And Sandi True, Field Applications Specialists 11/6/2025

    Hear Nico Chow and Sandi True, Field Applications Specialists, discuss working with customers to help them evaluate and implement Residual DNA Quantitation, Mycoplasma Detection, and Microbial Identification Assays.

  6. How To Fill And Empty Nunc Standard Closed Cell Factory System 3/21/2022

    Watch this step by step how to instructional video to learn how to fill and empty the Nunc Standard Closed Cell Factory System, which is a closed system built with standard components to help ensure quality and assurance of supply.

  7. Interview With Pharma Analytics Field Application Specialist - Sandi True 11/6/2025

    Hear Sandi True, a Field Applications Specialist discuss helping customers navigate challenges often encountered when evaluating and implementing Residual DNA Quantitation, Mycoplasma Detection, and Microbial Identification Assays.

  8. Thermo Fisher Scientific Bio-Expo Live 2024: Upstream Bioprocessing: A Next-Gen Medium And Feed System 8/15/2024

    This presentation reviews next-generation cell culture media and feed options and a recent successful scale-up case study done in collaboration with Centre for Biochemical Engineering and Cell Cultivation Techniques at the Zurich University of Applied Sciences.

  9. 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.

  10. Thermo Fisher Scientific Customer Experience Center Overview 5/19/2025

    Explore cutting-edge single-use technologies with hands-on training at the Customer Experience Center, which is an immersive hub for innovation, learning, and bioprocessing expertise.