Spray drying is a continuous, reproducible, cost-effective and scalable process for the production of stable amorphous solid dispersions.
This technology enables the production of dry pharmaceutical powders for tablets, powder-filled capsules and inhaled drug products.
The dispersion of a drug in a polymer matrix results in enhanced solubility in intestinal fluids and improved bioavailability.

To enable rapid product development and file submission it is paramount to integrate CMC strategies and regulatory aspects early in the drug product development process.
CMC demands are growing throughout the clinical phases and they require phase appropriate expertise and management skills.

This webinar will address key CMC challenges and integrated project management solutions for spray dried pharmaceutical product development.

Presenters
Stefano Console
Scientific Advisor
Stefano Console has more than 30 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 Ardena.
Stefano received his five-year degree in Chemistry from the University of Milano, Italy.

Arno Vermote
Senior CMC Writer
Graduated in Pharmaceutical Sciences and having obtained a PhD in medicinal chemistry, he started his career as a medical writer for a Belgian CRO. Later he joined Ardena as a CMC Writer and rapidly grew to Senior CMC Writer. His role is to provide regulatory advice to clients as well as to write regulatory documentation for new chemical entities in clinical studies. Next to providing assistance and support to clients, he also fulfills a role in technical sales for the Ardena Dossier Development team. Having a background in medicinal chemistry and being a pharmacist by training, Arno combines knowledge and expertise in both drug substance and drug product development.

In this webinar you will learn what it takes to bring a candidate from the laboratory to first-in-human clinical trials, with a focus on a phase-appropriate strategy for drug substance process and analytical development, scale-up and manufacturing.

We will discuss key aspects that must be addressed to successfully transform a medicinal chemistry route into a manufacturing process capable of delivering a drug substance of necessary quality for clinical trials:

Alternative chemical route scouting and route comparison.
Challenges in scaling up of a new synthesis route for the target drug substance.
Development of analytical package: analytical methods, in-process controls, quality specifications.
Investigation of the impurity profile in drug substance, highlighting the importance of detecting and quantifying impurities and tracking these back to their point of origin.
Importance of solid-state research for drug substance: salt and polymorph screens, development of crystallization step and more.
General aspects of project development to address the need for fast delivery of drug substance often associated with projects in early clinical development phase.

Presenters
Juris Fotins, PhD
Principal Scientist
Drug Substance Process Development
With a PhD in organic chemistry and more than 15 years of experience, his professional career in medicinal chemistry started at an academic institution In Latvia. Later moved to process chemistry at local pharmaceutical company. Joined Ardena as principal scientist focusing primarily on development of manufacturing processes for various drug substances. Currently, next to managing chemistry projects, is also involved in technical sales for Ardena Sodertalje.

Petter Tollbäck, PhD
Principal Scientist
Drug Substance Analytical Development
More than 15 years of experience of pharmaceutical development.
Developed hundreds of methods for a large variety drug substances and products – pre-clinical to commercial.