Integrated Approach to Spray Drying for Optimized Oral and Vaccine Formulations
Sponsored by: Catalent
- End To End Spray
- Formulation Development
Date: 18 May
Time: 4PM London/11AM New York
Developers and manufacturers are increasingly adopting spray drying as a formulation enabling technology to develop amorphous solid dispersion of poorly soluble drugs. In addition, spray drying seems to be a promising approach for the stabilization of vaccines. However, poor understanding of physicochemical stability between the API and excipients, manufacturability and downstream processability could limit its use in commercial manufacturing.
In this webinar, an academic expert will discuss optimal design space parameters involved in developing spray dried dispersion of poorly soluble drugs for oral and vaccine delivery. A Catalent expert will then highlight the influence of key formulation and process variables on the physical structure and stability of spray dried small molecules, to ensure a seamless scale-up to clinical manufacturing and commercial launch.
Pavan Mutill, Ph.D,
Associate Professor, Dept. of Pharmaceutical Sciences, College of Pharmacy, University of New Mexico
Dr. Muttil is an Associate Professor with tenure in the Department of Pharmaceutical Sciences at the University of New Mexico (UNM), New Mexico, USA. He has research experience in aerosol formulation and characterization, and pulmonary delivery of drugs and vaccines in preclinical models. For more than 15 years, he has used the spray drying technique to formulate dry powders; these dry powders, containing both drugs and vaccines, have been evaluated by the pulmonary route of administration in various animal models. In addition, he is the chair of the admissions committee for the Pharm. D. Program in the College of Pharmacy at UNM and is passionate about student mentoring at various levels of education.
Stephie Lee, M.S.,
Associate Director, Pharmaceutics, Catalent
Stephie Lee, M.S., is Associate Director, Pharmaceutics at Catalent’s San Diego facility. The site focuses on product development and analytical services. She has a broad background in preclinical and clinical formulation, process development and GMP manufacturing of small molecule candidates, with a focus on early phase strategies for bioavailability enhancement of poorly soluble compounds. Ms. Lee has managed more than 60 oral formulation programs, including spray dried dispersion, fluid bed processing and micronization projects. Prior to joining Catalent, Ms. Lee was a researcher at the University of California, Los Angeles (UCLA), where she focused her research on the effects of various reaction conditions on the morphologies of nano conductive polymers. Ms. Lee holds a master’s in chemistry and a bachelor’s in Biochemistry from UCLA.
Key Learning Objectives
- Understand the optimal design space for early evaluation of spray drying of poorly soluble drugs for oral and vaccine delivery
- Learn more about the interplay between key formulation/process variables and product quality to ensure seamless scale-up
- Discover how integrated spray drying services can help minimize risk and save valuable time in development and manufacturing
- Senior/Director New Product Strategy & Development
- Senior/Director Product Development
- Senior/Director R&D
- Formulation Scientists
- Project Leaders/Project Management
- Head/Senior/Director - CMC
- Senior/Director - Strategic Sourcing and Consultants