Analytical Strategies in API Development: Driving Innovation, Embracing Digitalization, Navigating Regulation

Arina Ceausu, R&D, TAPI, Tel Aviv-Jaffo, Israel (arina.Ceausu@tapi.com)

The analytical strategies in generic API development, guided by the scientific regulatory framework and expectations, require periodical evaluation to enable an efficient support of the needs, employing new technologies and promoting innovation.

This lecture is intended to present three main areas that support the analytical strategies, as reflected in API industry and specifically in TAPI R&D:

• Systematic Analytical Method Development approach – tools and methodologies;
• Analytical Control strategies of manufacturing process and drug substance driven by the evolution of science and technology – introducing advanced analytical techniques;
• Digitalization of API R&D labs - The implementation of a digital infrastructure and systematic use of modeling and AI is a strategic necessity, essential to fully realize the potential of modern R&D.

The main directions will be illustrated with representative examples.

Short Biography of Presenting Author

Head of Analytical & Regulatory Science, Global API R&D, with broad experience in analytical research and development, defining analytical strategy approach and overseeing analytical API development from laboratory research to DMF submission and life cycle management. With proven contribution in implementation of innovative analytical technologies and driving digitalization initiatives.