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Nanoparticulate Impurities in Excipients – A Threat to Protein Stability



WEBINAR

One main reason for using excipients is to stabilize the active pharmaceutical ingredient, ensuring an effective and safe therapy. Pharmaceutical grade sucrose, an important and commonly used stabilizer, contains nanoparticulate impurities (NPIs) of 100-200 nm size originating from the starting raw material. In this webinar, the scientists behind the discovery discuss the characteristics of these NPIs, explain their impact on aggregate/particle analytics, and show, with the example of antibodies, that NPIs are a threat to protein stability. Their research has triggered the development of improved sucrose grades, that are low in NPIs to reduce the risk of unwanted instability.

In this webinar you will learn about:

  • The role of sucrose as a stabilizer in pharmaceuticals
  • The presence and characteristics of nanoparticulate impurities (NPIs) in pharmaceutical-grade sucrose
  • The impact of NPIs on protein stability
  • Sucrose with low NPI content

Speakers

Andrea Hawe, Ph.D.

Andrea Hawe, Ph.D.

Coriolis Pharma

Chief Scientific Officer

Andrea Hawe is co-founder and chief scientific officer of Coriolis Pharma, a science-driven contract research organization for drug product development of biopharmaceuticals (protein, peptides, oligonucleotides, ATMPs, vaccines), with a focus on formulation, lyophilization technologies, and analytics (GMP and non-GMP). Andrea holds a Ph.D. from the LMU (Munich) in pharmaceutical technology. She is an expert in protein formulation and protein characterization, and she has published more than 50 articles in peer-reviewed journals.

Daniel Weinbuch

Daniel Weinbuch

Coriolis Pharma

Analytical Service Specialist

Daniel Weinbuch is an analytical service specialist at Coriolis Pharma. He holds a Ph.D. from the Leiden University (The Netherlands) in biopharmaceutical sciences, for which he studied the pharmaceutical aspects of subvisible particles. As part of his Ph.D. project, Daniel investigated nanoparticulate impurities (NPIs) observed in pharmaceutical-grade sugars. He works for Coriolis Pharma. His previous work experience includes positions at Ratiopharm (now Teva) in Germany and Boehringer Ingelheim in the U.S. and Japan.