Thermo Fisher Live Event Shorts
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CMC Considerations Around Unique Materials And Reagents
10/2/2026
In this segment from the Bioprocess Online Live event, “Making The Jump To GMP: Material Decisions For Clinical Manufacturing,” panelists advise on what to do when no GMP-grade equivalents exist for certain starting materials or reagents.
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The CDMO's Perspective: Audience Q&A With Thermo Fisher Scientific
10/2/2026
During this final segment from the Bioprocess Online Live event, “Making The Jump To GMP: Material Decisions For Clinical Manufacturing,” a representative and SME from the event sponsor enters the conversation. Mike Brewer, director and global principal consultant of regulatory and bioproduction at Thermo Fisher Scientific, joins the panel for a special Q&A session with the audience, discussing the challenges he’s witnessed sponsor companies face in the transition to clinical manufacturing.
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Demonstrating GMP Readiness And Understanding Common Pain Points
10/2/2026
In this segment from the Bioprocess Online Live event, “Making The Jump To GMP: Material Decisions For Clinical Manufacturing,” panelists discuss the most common challenges in scaling and transitioning a process into GMP manufacturing. They identify things such as supplier or CDMO constraints, facility fit, and technology transfers as some of the more prevalent challenges in this transition. Panelist Mary Rodley, an independent consultant at Medius Consulting, stresses the importance of risk assessments and advises developers on when they should be instituted.
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How Raw Material Decisions Can Impact Process Performance
10/2/2026
In this segment from the Bioprocess Online Live event, “Making The Jump To GMP: Material Decisions For Clinical Manufacturing,” panelists discuss how early-stage raw material decisions impact later-stage manufacturing and process performance, as well as the specific trade-offs to consider when it comes to raw materials for clinical manufacturing.
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Transitioning A Process And Qualifying GMP Materials
10/2/2026
This opening segment from the Bioprocess Online Live event, “Making The Jump To GMP: Material Decisions For Clinical Manufacturing,” features panelists Tiffany Rau, Ph.D., an adjunct professor at University College Cork, co-founder of BioPharam Technical Consulting, and founder of Rau Consulting; Mary Rodley, an independent consultant at Medius Consulting; and Wei Lu, Ph.D., a senior staff engineer in downstream process development at Takeda. They share their thoughts on when preparation for clinical manufacturing should begin, especially in terms of qualifying compendial and GMP-grade materials.
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Choosing The Right Metrics To Measure Process Performance
7/1/2026
In this opening segment from the Bioprocess Online Live event, “The Levers And Tradeoffs That Drive Process Productivity,” panelists David Scherr, Ph.D. (AstraZeneca) and Vadim Klyushnichenko, Ph.D. (Calibr-Skaggs), discuss what metrics matter the most to evaluate productivity and measure process performance.
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Upstream Decisions Influence Downstream Challenges
7/1/2026
In this segment from the Bioprocess Online Live event, “The Levers And Tradeoffs That Drive Process Productivity,” panelists David Scherr, Ph.D. (AstraZeneca) and Vadim Klyushnichenko, Ph.D. (Calibr-Skaggs), answer the question, “What should developers be thinking about upstream to avoid downstream complications?” Klyushnichenko believes process-wide considerations like this begin earlier than cell line development at the product’s molecular construct itself.
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Simplifying Downstream Unit Operations To Increase Productivity
7/1/2026
In this segment from the Bioprocess Online Live event, “The Levers And Tradeoffs That Drive Process Productivity,” panelists David Scherr, Ph.D. (AstraZeneca) and Vadim Klyushnichenko, Ph.D. (Calibr-Skaggs), discuss the biggest opportunity to improve process yield and performance: reducing chromatography steps and unlocking efficiencies downstream.
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Understanding Fixed Variables And Working Within Their Constraints
7/1/2026
Some things are intrinsic, unchanging realities of a process — molecular complexity, product developability, and facility fit, to name a few. In this segment from the Bioprocess Online Live event, “The Levers And Tradeoffs That Drive Process Productivity,” panelists David Scherr, Ph.D. (AstraZeneca) and Vadim Klyushnichenko, Ph.D. (Calibr-Skaggs), discuss these “non-pullable levers” of process development and advise teams on how to work within their boundaries.
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Next-Generation Molecules Challenge Notions Of Yield And Performance
7/1/2026
In this segment from the Bioprocess Online Live event, “The Levers And Tradeoffs That Drive Process Productivity,” panelists David Scherr, Ph.D. (AstraZeneca) and Vadim Klyushnichenko, Ph.D. (Calibr-Skaggs), discuss how the process-related associated with next-generation molecules like bispecifics and trispecifics complicate downstream purification efforts impurities (e.g., chain mispairings). They agree that mitigating these impurities is a developmental challenge both upstream and downstream.