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Lyophilization is one of the most important steps in designing a successful biologic drug product. The formulation and lyophilization techniques selected are critical to product stability and efficacy. Accordingly, many global biopharma companies rely on sugars and lyophilization in nearly all of their biologic drug products, and industry scientists pay close attention to advances in this field or to tools that make this process more predictable and better understood.
The designs of formulations and lyophilization cycles are critical for maintaining product quality in biologic drugs and the use of high-quality excipients, such as Ashland high purity low endotoxin (HPLE) sugars, is all but mandatory for regulatory compliance. Ashland vialose™ highly purified sugars can help to stabilize biologic formulations and overcome supply or quality related problems versus the competition. This joint webinar combines a wealth of industry expertise to provide a practical view of advancement in lyophilization technologies for HPLE sugars.
This hourlong session will highlight practical insights into:
Register for the webinar replay today to gain understandings of HPLE sugars and advancements in lyophilization technologies.
presenter information:
Wesley Cowperthwaite, MBA
Global Strategic Marketing Manager, Biopharma
Ashland
Wesley is a strategic marketing manager and business developer at Ashland, specializing in new chemicals for the biopharmaceutical market. He holds an MBA from the University of Maine and has around 10 years of experience as a scientist developing in-vitro rapid diagnostics.
Dennis Posheluk, PhD
Technical Product Manager and Associate Scientist
IMA Group
Dennis joined the technology and process development group at IMA Life North America in 2017, following the completion of his MS in mechanical engineering from the University at Buffalo. His work has focused on the research, development, and implementation of emerging freeze drying technologies and process analytical tools in pharmaceutical manufacturing.
Natália Marchesan Bexiga, PhD
Bionanomanufacturing Center Doctoral Researcher
Institute for Technological Research (IPT)
Natália holds a Bachelor's degree in Pharmaceutical Sciences, as well as a Master's degree, PhD and postdoctoral training in Biochemical-Pharmaceutical Technology from the University of São Paulo. Her expertise encompasses nanotechnology, synthetic biology and lyophilization. She has over ten years of experience in the development of lyophilized formulations and lyophilization cycles, including scale-up and technology transfer of lyophilization processes, as well as lyophilizer performance qualification. She also has extensive expertise in pre-formulation studies, including Differential Scanning Calorimetry (DSC) and Freeze-Drying Microscopy (FDM) for determining the critical temperatures of lyophilization formulations. In addition, she is highly experienced in post-lyophilization characterization techniques used to evaluate the critical quality attributes of lyophilized products, including solid-state NMR (ssNMR), FTIR spectroscopy, Karl Fischer titration, DSC and X-ray diffraction (XRD). As part of her doctoral training, Dr. Natália conducted research at the Johns Hopkins Bloomberg School of Public Health, where she gained international experience in nanotechnology and lyophilization. She is currently a doctoral researcher at the Bionanomanufacturing Center of the Institute for Technological Research (IPT), Brazil, and serves as a consultant specializing in pharmaceutical lyophilization. Her consulting activities include the development of lyophilization formulations, thermal characterization of formulations, design and optimization of lyophilization cycles and scale-up and technology transfer for pharmaceutical, veterinary and biotechnology companies, as well as compounding pharmacies. She also provides both theoretical and hands-on training in the lyophilization of pharmaceutical products.
Fengyuan (George) Yang, PhD
Principal Scientist
Ashland
Dr. Fengyuan (George) Yang is a principal scientist at Ashland. Before joining Ashland, he was an associate scientist at Merck & Co. He received his Ph.D. in Materials Science and Engineering from Johns Hopkins University. His research interest is the application of polymers on developing functional materials. Recently, he has actively worked on the application of polymeric excipients to better formulation and therapeutic performance. In the past few years, Dr. Yang has published three book chapters and ~40 papers in peer-reviewed journals with 1000+ citations.
Petr Kazarin, PhD
Research Scientist - Engineer
IMA Life North America
Petr Kazarin is a Research Scientist-Engineer at IMA Life North America, specializing in lyophilization process modeling, digital twin development and advanced process analytics. He holds a PhD in Aerospace Engineering and applies heat and mass transfer, CFD and data-driven modeling to improve freeze-drying process understanding, equipment capability assessment and real-time decision support for pharmaceutical manufacturing.
Roland Pérez Expósito
PhD Candidate - Chemical Engineering
Federal University of Rio de Janeiro
Roland is a Chemical Engineer and a PhD candidate at the Federal University of Rio de Janeiro (UFRJ), Brazil. He has over 20 years of experience in the pharmaceutical industry, with expertise in sterile manufacturing, pharmaceutical process validation, equipment qualification and lyophilization. His research focuses on the mathematical modeling, optimization and control of pharmaceutical freeze-drying processes, with an emphasis on robust process design, stochastic simulation and Quality by Design (QbD).
Looking to learn more about Ashland high purity low endotoxin (HPLE) excipients? Please reach out to your local Ashland solver about our product offering:
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