First-in-Human to Commercial: A Microdosing Journey

Register Free: https://www.pharmtech.com/pt_w/human

Event Overview:

This webcast will explore the benchmark practices for rapid progression from first-in-human to large-scale commercial manufacture for microdosing API. Xcelodose-based systems are an industry standard for rapid and accurate microdosing and an integral part of accelerated pathways to first-in-human studies. Utilization of the Xcelodose technology can increase speed to clinic and quickly assess new compounds while remaining cost-conscious. Upon successful clinical studies, scale up to large-scale manufacture has previously been a limitation. When micro-dosing with the innovative Harro Höfliger Modu-C Mid Speed Encapsulator, these limitations are no longer an impediment to scale-up and commercialization.

Key Learning Objectives:

• Xcelodose utilization for first-in-human studies
• Rapid transfer from first-in-human to commercial manufacturing
• Scale up to commercial production using the Harro Höfliger Modu-C MS Encapsulator

Who Should Attend:

• Anyone in the Oral Solid Dosage Manufacturing Industry

Speakers

Stephanie Sastre
Supervisor Process Engineering
Lonza

Mark Cappucci
Preformulation Team Lead
Lonza

Register Free: https://www.pharmtech.com/pt_w/human