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 Filipe Gaspar VP of R&D at Hovione |BOOK FREE SEAT
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 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.
Presented by Filipe Gaspar VP of R&D at Hovione
Filipe Gaspar was born in 1972, is a Vice-President and leads the Research & Development Department at Hovione FarmaCiência.
At Hovione he led the implementation of spray drying and then directed the RD group that developed further the technology. He was involved in +120 projects and was the lead scientist of several projects that reached commercial stage, including the first at Hovione submitted under Quality by Design. Before becoming a business leader, he was the Director of Drug Product Technologies with responsibility for selection and implementation of new technologies within the company. Before joining Hovione he worked in particle engineering using supercritical fluids.
Filipe holds a PhD in Chemical Engineering from the University of Birmingham, UK