Nanoparticulate Impurities in Excipients - A Threat to Protein Stability

Nanoparticulate Impurities in Excipients - A Threat to Protein Stability

Merck Life Science hosts this Webinar with Coriolis Scientists

A main reason for using excipients is to stabilize the active pharmaceutical ingredient and by that, 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, on 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:

  • The role of sucrose as a stabilizer in pharmaceutical
  • Presence and characteristics of nanoparticulate impurities (NPIs) in pharmaceutical-grade sucrose
  • Impact of NPIs on protein stability
  • Succrose with low NPI content

Registration for on-demand webinar - Click here

 

(CEST)
On demand
Dr. Andrea Hawe

Dr. Andrea Hawe

Speaker

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 focus on formulation, lyophilization technologies and analytics (GMP and non-GMP). Andrea holds a PhD from the LMU (Munich) in pharmaceutical technology. She is an expert for protein formulation and protein characterization, and has published more than 50 articles in peer-reviewed journals.

Dr. Daniel Weinbuch

Dr. Daniel Weinbuch

Speaker

Daniel Weinbuch is an Analytical Service Specialist at Coriolis Pharma. He holds a PhD from the Leiden University (The Netherlands) in Biopharmaceutical Sciences, for which he studied the pharmaceutical aspects of subvisible particles. As part his PhD project, Daniel Weinbuch investigated nanoparticulate impurities (NPIs) observed in pharmaceutical grade sugars. He works for Coriolis Pharma since 2013. His previous work experience includes positions at ratiopharm (now Teva) in Germany and Boehringer Ingelheim U.S. and Japan.