A comprehensive ecosystem for a successful cGMP Spray Drying strategy
Spray drying is a continuous, reproducible, cost-effective and scalable process for the production of dry powders from a liquid solution or suspension by rapidly drying with a hot gas. Spray drying is part of the wider microencapsulation technologies family, yet it has an amazing versatility. The main reason for its growth in the pharmaceutical industry in the recent years has been the formulation of amorphous solid dispersions for oral drugs to increase the solubility and bioavailability of poorly soluble compounds. Spray drying can be conveniently applied also to the manufacturing of dry powders for inhalation, microencapsulation of oxygen sensitive actives, taste masking, or powder in capsules for First-In-Man studies.
However, spray drying alone might be too short a story. Considering the Drug Product manufacturing perimeter as a whole, it is easy to understand that there is much more than just spray drying in a project that requires spray drying as enabling technology.
Spray drying technology needs an ecosystem to deliver its best and reduce the development time.
In this webinar we will take you on a journey to show how an ideal spray drying ecosystem should be. We will guide you to an ideal observatory, looking at the whole picture in which the enabling technology is paramount but in which, without the rest of the components, issues may arise increasing the project costs and delaying the time to market.
Head of Pharmaceutical Development and Manufacturing, Idifarma
Iñaki has more than 20 years of experience in the pharmaceutical industry, covering product development, process transfer, scale-up and industrial manufacturing.
Iñaki, has led the definition of internal procedures for drug development in accordance with the current regulatory requirements of "Quality By Design" (QbD), applying the tools of risk analysis, design of experiments (DoE), design space and control strategies. He participated in the design of the facilities and in the start-up of Idifarma's spray drying plant under GMP standards.
Iñaki has a degree in Pharmacy from the University of Navarra (Spain), and he is a Specialist in Industrial Pharmacy and Pharmaceutical Development.
Pharmaceutical Development and Spray Drying Manufacturing Scientist, Idifarma
Javier Gurrea has 5 years of experience in Pharmaceutical Development and GMP Manufacturing. His work is focused on the development and manufacturing of drug products with Spray Drying technology.
He has been involved in numerous projects based especially on amorphous solid dispersions, as well as working on other applications of this technology including micro and nanoparticles.
Javier has a double degree in Pharmacy and Nutrition from the University of Navarra (Spain).
Senior Advisor, Oriento
Stefano Console has more than 27 years of experience in the pharmaceutical and fine chemical business. The broad experience gained with different CDMOs coupled with an unceasing scientific curiosity for new technologies led Stefano to hold strategic roles managing a large number of successful projects for big as well as small Pharma partners across EU, USA and Japan. A vibrant passion for business development, organizational innovation and start-up initiatives, together with a relevant expertise in pharmaceutical particle engineering technologies (especially micronization and spray drying related technologies) and respiratory products complete the profile.
Currently Stefano is Senior Advisor and Founder at Oriento SA, Member of the Advisory Board at eu.reca (European Respiratory Cluster of Antwerp) and Scientific Advisor at Idifarma.
Stefano received his five-year degree in Chemistry from the University of Milano, Italy.