Aggregation of therapeutic proteins can occur during all steps of drug product manufacturing and handling. One option to efficiently prevent protein aggregation in solution is the application of excipients. Depending on the underlying mechanism of protein aggregation, different classes of excipients such as stabilizers and surfactants are required to stabilize the protein. Stabilizers enhance protein stability in the bulk whereas surfactants efficiently prevent agitation- and surface-induced protein aggregation.
This webinar will provide a comprehensive overview of protein aggregation, underlying mechanisms, and stabilization techniques using (novel) excipients in parenteral formulations.
In this webinar, you will learn:
- About mechanisms involved in the formation of protein particles
- Why different classes of excipients are required to prevent protein aggregation
- About our novel surfactants/stabilizers and their capability to overcome challenges associated with protein instability
Speakers
Michelle Pascale Zoeller
Merck
Senior Scientist
Michelle Zoeller is a senior scientist focusing on novel modality formulation at Merck. She has 6 years of experience in the field of parenteral formulations of proteins and novel modalities. Michelle holds an M.Sc. in biomolecular engineering from TU Darmstadt. She then participated in a joint Ph.D. program between Merck, Heidelberg University, and the Steinbeis Transfer Center of Biopharmacy and Analysis, during which she worked on the characterization of novel surfactants for the formulation of therapeutic proteins.
Can Araman, Ph.D.
Merck
Senior Manager, Lab Head
Can Araman is a senior manager heading the protein formulation laboratory in Merck's process solutions department in Darmstadt, Germany. His team is working on delivering solutions to challenges in protein formulations stemming mainly from the viscosity and aggregation of proteins. Can holds a Ph.D. from the Institute of Biological Chemistry in Vienna and has had a long-lasting experience in protein biochemistry, including antibody and ADC development for pre-clinical studies and clinical trials.
Pharma and biopharma manufacturing
- Detecting & Removing Aggregates
期间:1h
语言:English
场次 1:往期 August 31, 2023
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