Overcoming formulation challenges for mRNA and high-concentration proteins

In this webinar, experts will discuss how to improve formulation development of high-concentration mAbs to reduce viscosity, and potentially reduce costs and timelines.

Register Free: https://www.pharmtech.com/pt_w/mab-formulations

Event Overview:

In recent years, the industry witnessed new demand for protein delivery and the emergence of advanced modalities, such as mRNA. However, their development is met with technical challenges, including high-concentration formulations, stability and degradation. To address those concerns, optimizing formulation components, including high-throughput analytics methods, automation, statistical approach, and excipient design can help. In this webinar, experts will discuss how to improve the formulation development of high-concentration mAbs for subcutaneous delivery to reduce viscosity, and potentially reduce costs and timelines, and how to overcome current challenges met in formulating mRNA lipid nanoparticles (mRNA-LNP).

Key Learning Objectives:

• The benefits of high-throughput analytics method, automation, and statistical approach in the development of high-concentration mAb formulation
• A case study for an IgG1 mAb and proprietary, novel excipients to reduce the viscosity of high-concentration biologics
• Challenges in formulating mRNA lipid nanoparticles (mRNA-LNP)

Featured Speaker:

Yunsong (Frank) Li, Ph.D.
Director of Product
Development
Catalent Biologics

Dr. Yunsong Li is the Senior Director of Product Development at Catalent’s Bloomington, Indiana facility leading the process, analytical and formulation development teams. He also serves as Adjunct Associate Professor in The Department of Industrial & Physical Pharmacy at Purdue University. Previously, Dr. Li worked at Merck for over 7 years in various roles including, but not limited to group leader for analytical method development and high throughput testing, group leader for biophysical characterization, and Associate Principal Scientist in formulation development. Prior to Merck, Dr. Li worked for Amgen as a scientist responsible for late-stage drug product development including formulation, fill finish process development and lyophilization scale-up. Dr. Li has a Ph.D. in Pharmaceutical Chemistry from The University of Kansas, a M.Sc. in Chemistry from the University of British Columbia and a B.Sc. in Chemistry from Peking University in Beijing. He has published over 10 peer-reviewed publications.

Elizabeth Topp, Ph.D.
Professor
Purdue University

Elizabeth Topp is a Professor in the departments of Industrial and Physical Pharmacy and Chemical Engineering at Purdue University in West Lafayette, Indiana, and Chief Scientific Officer (CSO) for the National Institute for Bioprocessing Research and Training (NIBRT) in Dublin, Ireland. She holds a bachelor’s degree in chemical engineering from the University of Delaware (B.Ch.E.), a master’s degree in chemical and biochemical engineering from the University of Pennsylvania (M.E.), and a doctorate in pharmaceutics from the University of Michigan (Ph.D.). She began her academic career in the Department of Pharmaceutical Chemistry at the University of Kansas, moving to Purdue University in 2009 to accept a position as the Dane O. Kildsig Chair and Head of the Department of Industrial and Physical Pharmacy, a position she held until 2017. Currently, she maintains her Purdue faculty position while serving as NIBRT CSO on partial academic leave. Dr. Topp is the Co-Founder and Co-Director of LyoHUB, an industry-led consortium to advance lyophilization technology. She has served as a member and chair of the FDA Advisory Committee on the Pharmaceutical Sciences and Clinical Pharmacology, as Associate Editor of the Journal of Pharmaceutical Sciences, and as a standing member of several NIH study sections. She is a recent recipient of the Chaney Faculty Scholar Award from Purdue’s College of Pharmacy, and of the Michael J. Pikal NIPTE Distinguished Scholar Award in Pharmaceutical Processing. She has received awards recognizing her contributions as a teacher and graduate mentor. Dr. Topp is a Fellow of the American Association of Pharmaceutical Scientists.

Register Free: https://www.pharmtech.com/pt_w/mab-formulations