From Molecule To Patient: Phase-Appropriate API Development Strategies
From Molecule To Patient: Phase-Appropriate API Development Strategies
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:
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.
