Quality-By-Design in Spray Drying Processes – Transfer Lab to Production
19th February 2019 | 10am EST | Sune Klint Andersen at Janssen Pharmaceutical Companies of Johnson & Johnson and João Vicente Senior Scientist - Particle Engineering Team Leader at Hovione |WATCH FOR FREE
Spray drying is a continuous and scalable manufacturing process commonly used in the pharmaceutical industry. Due to its scalable and continuous nature it is possible to apply Quality-by-Design (QbD) and Process Analytical Technologies (PAT) early on in the development of a spray drying process.
Knowledge gained from QbD e.g. Design-of-Experiments (DoE) and PAT increases process understanding and the knowledge can be readily applied when scaling up the process and in production scale application of PAT i.e. especially with respect to the control strategy.
The Webinar will discuss the application of QbD early in the development and how the obtained knowledge can be used to optimize transfer of the spray drying process to production scale including PAT strategy.
Presented by Sune Klint Andersen, Principal Scientist at Janssen Pharmaceutical Companies of Johnson & Johnson
Sune Klint Andersen is Principal Scientist for Spray Drying at the Janssen Pharmaceutical Companies of Johnson & Johnson. He has a Ph.D. in Chemical Engineering. He has worked with pharmaceutical spray drying for 17 years within process development for R&D and commercial scale, application of Quality-by-Design and PAT, particle engineering, drying kinetics, aseptic spray drying and advantages and disadvantages of spray vs freeze drying processes. He previously worked at Novo Nordisk for 7 years.
Sponsored by Hovione
Hovione is an international company with over 58 years of experience as a CDMO and is currently a fully integrated supplier offering services for drug substance, drug product intermediate and drug product. With four FDA inspected sites in USA, China, Ireland and Portugal and development laboratories in Portugal and USA, the company provides branded pharmaceutical customers services for the development and compliant manufacture of innovative drugs including highly potent compounds. For generic pharmaceutical customers the company offers niche API products. Hovione also provides proprietary product development and licensing opportunities for drug products. In the inhalation area, Hovione is the only independent company offering a complete range of services.
Followed by João Vicente Senior Scientist – Particle Engineering Team Leader at Hovione
João Vicente is currently the Leader of the Particle Engineering Group within the Research & Development Department at Hovione FarmaCiencia. His research, over the last 10 years, has been focused on the development of predictive tools and scale-up methods to expedite process development. Before becoming the leader of the Particle Engineering Group, João Vicente worked at Hovione as Drug Product Development Scientist and participated in the Development and Validation of several manufacturing processes of spray dried products. João Vicente holds a Masters in Biological Engineering and a Ph. D. in Pharmaceutical Technology.