Highly potent APIs: The current trends and challenges

24

September

  • 3PM London / 10AM New York
  • Free

Why attend?

Demand is growing for high potent APIs (HPAPIs) to treat greater numbers of patients with serious diseases, with oncology a key area.

However, there are considerable complexities involved with manufacturing HPAPIs and particular caution is required due to the toxicity of materials. Any manufacturing of APIs requires experienced specialists.

Internationally respected CDMO Indena covers every aspect of HPAPI manufacturing from late-preclinical to clinical and commercial phases.

In this webinar, we look at the current trends and challenges impacting HPAPIs from three different perspectives. Indena representatives will provide insight for:

– R&D: where it all begins for HPAPIs

– Technical operations: Manufacturing once process development has been defined

– Business development: The market for HPAPIs. How it’s going to grow and the types of investments

Speakers

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Jonathan GUITER
Business Development Manager – HPAPI

Jonathan Guiter has over a decade of experience in the pharmaceutical industry, focusing on CDMO of high potent APIs (HPAPIs) and complex APIs. Jonathan is currently Business Development Manager at Indena, leading CDMO services for Europe and Asia. Before joining Indena, Jonathan managed the custom synthesis business at Zambon’s Zach System and held key roles at Safic-Alcan, overseeing API sourcing and commercialization. Jonathan began his career at GSK, synthesizing API in R&D Discovery department. He holds a Master's degree in Chemistry from Chimie ParisTech - PSL and an engineering chemical degree from ESCOM.

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Luca Domenighini
R&D Researcher

Luca Domenighini is a scientist specialized in the synthesis and manufacture of active pharmaceutical ingredients. Graduated at “Università degli studi di Pavia” and trained in the organic synthesis, Luca joined Indena in 2011.

He is currently working as a project leader on different CDMO projects regarding HPAPI, spacing from the development/optimization of the manufacturing process to the scale up working from grams to Kg. In his experience he’s faced all the main topics regarding the process, including the handling, synthesis purification and drying of these active substances.

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Francesco Fasanella
Process Technology Manager

Francesco Fasanella is a Process Technology Manager at Indena, Italy. His primary responsibilities, in addition to the daily supervision of pilot departments, include resource management, the implementation of new technologies, and, in collaboration with other key company figures, the management of new production projects, from the assessment of plant feasibility to the final realization of the process. Francesco holds a Master's degree in Organic Chemistry from the University of Milan, where he collaborated as a researcher for two years in the Natural Organic Substances laboratories after completing his studies.

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