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Overviews of Lyophilization Process Steps and Mechanisms for Biological Molecule Stabilization during Freezing, Drying and Storage

This event is now available on demand.

Event Overview:

In the first 10 minutes, Ascendia Pharmaceuticals will present its expertise and capabilities in nanoparticle technologies. In the following 40 minutes this webinar will be focused on lyophilized formulations of biological molecules (eg, proteins). This presentation will examine the main steps in the lyophilization process and the mechanisms by which excipients provide stabilization to protein during freezing, drying, storage, and reconstitution. The key physical factors governing long-term stability also will be discussed. During freezing, effective excipients (eg, sucrose or trehalose) stabilize proteins by the preferential exclusion mechanism. During drying the stabilizer molecules replace water molecules removed from the surface of the protein (water replacement mechanism). Surfactants can stabilize the protein during freezing and minimize aggregation during reconstitution. For long-term storage stability, minimal criteria include retention of native protein structure during freezing and drying; a formulation glass transition temperature well above the planned storage temperature; and relatively low residual water content (eg, 1%).

Key Learning Objectives:

In this webinar you’ll learn:
  • Ascendia’s expertise and capabilities
  • The main steps in the lyophilization process and how proteins behave during these steps
  • The mechanisms for protein stabilization by excipients during freezing, drying, storage, and reconstitution
  • The minimal physical criteria for assuring long-term stability of lyophilized protein formulations
Who Should Attend: 
  • Formulation scientists in industry
  • Analytical chemists in industry
  • University students and professors
  • Managers, VPs, chief scientific officers, pharma consultants, and regulatory scientists


Featured Speakers

Shaukat Ali, PhD
Shaukat Ali, PhD
Senior Director of Scientific Affairs and Technical Marketing
Ascendia


Shaukat Ali, PhD, received his PhD degree from the City University of New York in chemistry and carried out his postdoctoral work in physical biochemistry at the University of Minnesota and Cornell University. His areas of expertise include liposomes, lipid nanoparticles, amorphous solid dispersions, SEDDS, controlled release technologies, and film technologies. He has published over 60 scientific and technical papers and holds several US and European patents. Dr Ali is a member of the editorial advisory boards of American Pharmaceutical Review, BioPharma Asia, and Contract Pharma, among other journals. Dr Ali is currently serving as a member of USP Excipients Test Methods Expert Committee (2020-2025). He is the recipient of IPEC Foundation’s Henk de Jong Industry Research Achievement in Excipient Technology Award for his significant contributions in the field of excipient technologies. Dr Ali is an American Association of Pharmaceutical Scientists fellow.



John Carpenter, PhD
John Carpenter, PhD




John F. Carpenter, PhD, is a professor emeritus of pharmaceutical sciences at the University of Colorado Skaggs School of Pharmacy and Pharmaceutical Sciences, and a cofounder and codirector of the University of Colorado Center for Pharmaceutical Biotechnology. His research interests include mechanisms for protein degradation and stabilization in pharmaceutical formulations during bioprocessing and in drug-delivery systems. He has worked for several years to define rational strategies for stabilizing proteins and vaccines during freeze-drying and storage in the dried solid. He has published more than 300 peer-reviewed papers and is an inventor on more than 30 patents. He is editor for reviews and commentaries for the Journal of Pharmaceutical Sciences. He serves on the editorial advisory boards for Pharmaceutical Research, The AAPS Journal, Journal of Pharmaceutical Sciences, Current Pharmaceutical Biotechnology, Molecular Pharmaceutics, and BioPharm International. He has received several teaching awards and the Ebert Prize. He is a fellow of the American Association for Advancement of Science, the American Association of Pharmaceutical Scientists (AAPS) and the National Academy of Inventors. He has received the AAPS Research Achievement Award in Biotechnology. He also was a cofounder and an organizer for the Colorado Protein Stability Conference.


For any technical questions please contact David Ambrose: DAmbrose@mjhlifesciences.com