Ascendia

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.

https://www.pharmtech.com/pt_w/biological-molecule-stabilization

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%).

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

Managers, VPs, chief scientific officers, pharma consultants, and regulatory scientists


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 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.



Webcasts

Webinar Date/Time:
Mon, Jun 24, 2024 11:00 AM EDT

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

With more insoluble chemical entities emerging from the drug discovery pipeline comes the challenge of finding the appropriate technology for improving solubility and bioavailability. Ascendia’s enabling platform technologies can help overcome these challenges by designing better and smarter formulations for oral and parenteral drug molecules across all modalities. Ascendia’s expertise and cGMP capabilities in manufacturing of innovative and complex generics can help expedite the development process of oral and injectable drugs, and reduce time and cost.

https://www.pharmtech.com/pt/nanotechnologies

How to tackle poorly soluble molecules across all modalities

What to know about polymeric nanoparticles (PNPs) and lipid nanoparticles (LNPs)

cGMP manufacturing and capabilities of PNPs/LNPs

Formulation scientists working with poorly soluble small and large molecules

Managers, vice presidents and chief scientific officers working with challenging molecules

Students and professors interested in innovative approaches for improving the solubility and bioavailability of molecules


Sr. Director Scientific Affairs and Technical Marketing
Ascendia Pharma

 joins Ascendia Pharmaceuticals Inc. as senior director of scientific affairs and technical marketing after having worked in the pharma and biotech industry for nearly 30 years. His areas of expertise include lipid chemistry; liposomes; surfactant-based drug delivery systems; SEDDS/SMEDDS; amorphous solid dispersions; oral, parenteral, topical and transdermal drug delivery; and immediate and controlled release formulations. He received his PhD in Organic Chemistry from the City University of New York and received postdoctoral training in Physical Biochemistry of lipids at the University of Minnesota and Cornell University.

Dr Ali has published over 60 articles in scientific journals and is an inventor/coinventor of several US and European patents. He is the recipient of IPEC’s Henk de Jong Industrial Research Award. He has served as the USP council of experts for the General Chapters-Physical Analysis (2010-2020), and continues to serve as USP council of experts for the Excipient Test Methods committee (2020-2025). He is co-chair of the AAPS Lipid Focus Group.


Webinar Date/Time: Thu, Nov 2, 2023 2:00 PM EDT

Frontiers in Nanotechnologies for Delivery of Small Molecules and Biologics

Learn about the challenges with poorly soluble drugs, the sterile and non-sterile capabilities for injectable and oral formulations, and more!

https://www.pharmtech.com/pt_w/nanoparticle-platform

Enabling technologies to overcome the solubility and bioavailability challenges for oral and parenteral formulations

Sterile and non-sterile capabilities for injectable and oral formulations

Formulators working in early phase pre-formulation/formulation and manufacturing of innovative molecules

Industry leaders (CSO, VP, R&D, Managers) with interest in lipid nanoparticles and drug delivery of biologics and large molecules

Students and faculty from universities working in the lipid nanoparticles and drug delivery


Sr. Director Scientific Affairs & Technical Marketing
Ascendia Pharmaceuticals


 has over 29 years in the pharmaceutical industry. He has expertise in lipids and liposomes drug delivery, and drug discovery and formulations development. Dr. Ali received his PhD in Chemistry from the City University of New York and postdoc training at the University of Minnesota and Cornell University. He has published over 50 articles in scientific journals and inventor/co-inventor of 14 US patents. He is a member of AAPS and ACS. He has served as a member of the editorial advisory board on many leading industry publications and journals, and has had the opportunities to serve as a USP panel of expert in General Chapters- Physical Analysis (1010-2020) and Excipient Test Methods committee (2020-2025). He is the recipient of IPEC Foundation’ 2020 Henk de Jong industrial research award for his contributions to formulations and excipient technologies.



Webinar Date/Time: Tue, Feb 28, 2023 2:00 PM EST

Nanoparticle Platform Technologies for Efficient Oral and Parenteral Drug Delivery

Articles

This white paper from outlines the best steps to establish an efficient drug formulation development process to stay within budget and meet timelines. 