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.
Juris Fotins, PhD
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
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.
Our team members share deep, scientific understanding and insights into their respective fields of expertise.