In the pharmaceutical industry the production of spray dried powders is still based on the batch concept. The quantities required in the early stages of the development are typically small but may increase by several orders of magnitude as the drug candidate advances through the clinical phases and reaches the market. A spray drying process can scale-up directly from the laboratory to a final production scale, however some quality attributes of the product may change during the scale-up, namely particle size and bulk density. Therefore the need for robust process understanding is essential in order to control and improve powder properties and minimize use of expensive materials during drug development.
The scope of this webinar is to describe some predictive tools and methodologies that can be used to support process/product development and scale-up activities. The development tools and methodologies aim to ensure that product and process development is as straightforward and predictable as possible.
Key Learning Objectives:
- Fundamental principles of the spray drying process
- Considerations about the different spray drying scales
- Scale-up methodology: From lab to commercial scale
- Development by design initiative
Márcio Temtem, Associate Director, Particle Design and Formulation Development, Hovione
Márcio Temtem is currently Associate Director for Particle Design and Formulation Development at Hovione. He joined the company in 2008 and has been since involved in the development of the Particle Design and Drug Product Business of the company. Márcio is a PhD in Chemical Engineering with several papers and patents published in topics such as Green Chemistry, Controlled Release, Inhalation, Drug Product, Particle Engineering and Solubility Enhancement.Message Presenter
João Vicente, Team Leader, Particle Engineering and Solubility Enhancement, Hovione
João Vicente has an academic background in Chemical Engineering and Pharmaceutical Technology, holding a Masters in Biological Engineering and a PhD in Pharmaceutical Technology. He developed expertise in Quality by Design, statistical analysis and process modeling, scale-up methods, and particle engineer technologies with particular emphasis to spray drying and microfluidization. He worked within the highest standards of quality (GMP’s) and participated in the development and validation of several manufacturing processes. João Vicente is currently Team Leader for Particle Engineering and Solubility Enhancement at Hovione.Message Presenter
Who Should Attend?
- Drug Product and Particle Engineering specialists
From Pharmaceutical and Biotechnology companies and regulators
HOVIONE has been dedicated for 57 years to helping pharmaceutical customers bring new and off-patient drugs to market.
- Fully integrated supplier offering from drug substance to drug product intermediate to drug product.
- Four FDA inspected sites and two development laboratories, it provides branded pharmaceutical customers services for the development and compliant manufacture of innovative drugs and is able to support highly potent compounds.
- For generic pharmaceutical customers it offers niche off-patent API products.
- In the inhalation area it is the only independent company offering a complete range of services.