Establishing strong process characterization and validation early is critical to ensuring biologics are developed efficiently, in compliance, and ready for scale—but these steps are often underestimated and overlooked until late in development. In this webinar, experts from Thermo Fisher Scientific will share real-world case studies showing how robust, data-driven process design accelerates validation readiness and reduces manufacturing risk. Learn how an integrated approach to process understanding can help you move faster from development to commercial success.
Experts from Thermo Fisher Scientific will share real-world case studies demonstrating how efficient tech transfer, analytical, and manufacturing strategies have helped biopharma innovators achieve validation readiness faster—without compromising quality or compliance. Through these examples, participants will learn:
Sabine Beate Zollner
Global PV and CMC Lead, Pharma Services Group, Thermo Fisher Scientific
Sabine Zollner is a Global CMC and Process Validation Lead in the Pharma Services Group at Thermo Fisher Scientific to provide cohesive, internally, and client-aligned CMC commercialization strategies for late-stage drug development programs. She has more than 25 years of pharmaceutical industry experience in small and large molecule research, drug, and process development, with emphasis in Chemistry, Manufacturing and Controls (CMC) for both, small and large molecules. In addition, she acquired profound experience in in vivo biology and toxicology models for small and large drug development prior to entering FIH clinical phase I. Her experience in technical CMC support for drug and process development spans the product life cycle, from Phase I to late stage programs, marketing applications into post-approval lifecycle and change management. She holds a Master’s degree and PhD in Biomedical Sciences in Virology and is based in Lengnau, Switzerland.
Sam Ruesing
Senior Staff Scientist in Downstream Process Development at Thermo Fisher Scientific
Sam Ruesing is a Senior Staff Scientist in Downstream Process Development at Thermo Fisher Scientific. He holds a bachelor’s degree in chemical engineering from the Missouri University of Science and Technology and PhD in biomedical engineering from Saint Louis University. Sam’s 12 years of experience spans all aspects of downstream development, including early-phase development for first-in-human production, adapting processes to new manufacturing facilities or scales, and late-phase optimization and characterization in preparation for commercialization.
Alyssa Siedle
Alyssa Siedle is the Manager of Upstream Process Development at Thermo Fisher Scientific
Alyssa Siedle is the Manager of Upstream Process Development at Thermo Fisher Scientific, where she leads teams responsible for developing, scaling, and transferring upstream processes for biologics manufacturing. She holds a master’s degree in Biochemistry and Biotechnology from the University of Missouri - St. Louis and has over ten years of experience across upstream development, manufacturing support, and quality operations. Throughout her career, Alyssa has supported and led successful technical transfers from development into GMP manufacturing, including complex and first-in-network processes. Her experience spans development, process characterization, and cross-functional collaboration to ensure robust, manufacturing-ready upstream processes.