Manufacturing And Sustainability

31. 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.

32. 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.

33. 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.

34. 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.

35. Thermo Fisher Scientific Suzhou, China Manufacturing Site Capabilities 11/2/2018

    Watch this video to learn more about this manufacturing site capabilities, quality management systems, PPI implementation, product expansion, assurance of supply and lead times.

36. Fast Track Your Path To Commercialization 5/21/2025

    Discover key strategies for scaling biologics from bench to pilot scale and learn how to overcome challenges in process development, including control of agitation, oxygen, CO₂, and nutrient supplementation.

37. Cell Culture Media Manufacturing, Paisley, Scotland 11/4/2025

    Learn more about our cell culture media manufacturing global network, including details of the Paisley, Scotland site's capacity expansion supporting the bioprocessing industry's rapidly growing needs.

38. A Collaboration With Zurich University Of Applied Sciences 5/19/2025

    Explore ZHAW’s pioneering work and collaboration in cell cultivation and bioprocessing to deliver scalable, high-performance solutions that address key challenges in biomanufacturing scale-up.

39. Manufacturing Friendly Aggregate Clearance In Downstream Processing 5/19/2025

    In this webinar, results are shared from the evaluation and preliminary optimization of a mixed-mode chromatography unit operation designed for aggregate removal in flow-through mode using a high-throughput POROS resin with immobilized caprylic acid.

40. Aegis Film For DynaDrive Single-Use Bioreactors 3/30/2026

    PFAS-free bioreactor film technology provides proven biocompatibility and strength across workflows while simplifying validation and reducing material variability for compliant operations.