Dr. Jerome Kim, International Vaccine Institute Korea
Won Min Kin, Celltrion
In today’s pharmaceutical and biopharmaceutical industry, new therapies employ a greater number of different products manufactured in medium-to-low production batches. INJECTA, IMA Life’s innovative approach to handling RTU components, ensures a high degree of flexibility thanks to the intensive use of robotic-driven manipulations. INJECTA responds to the increasing complexity of new drug substances improving product quality, and manufacturing safety and efficiency. Our challenge is to push back the barriers even further to provide the market with a solution offering both agility and compliance, through advanced robotics to achieve true gloveless processing.
Penati Alberto, EU Engineering, Senior Director, Patheon Thermo Fisher Scientific
Luigi Annoni, Senior Aseptic Specialist, IMA Life
Beth Kroeger, Senior Technical Service Manager (Steris)
Enrico Barichello, Stevanato
EMA Speaker (TBC)
Max Fernandez, Samsung Biologics (Invited)
Hirorito Katayama, Novartis
Edward Wang, Chief Technology Officer, China Operations, Sirnaomics Inc
Sharing two important quality concerns of rubber closure for pharmaceutical injectables industry.
Particulates have always been one of the top reasons for drug recalls and a focus for the pharmaceutical industry to ensure patient safety and compliance. Therefore, we will explore, in particular, intrinsic rubber particles possibly generated from the rubber stoppers of a vial system; how they are generated, factors resulting in their generation and corresponding ways to reduce the risk.
Lyophilization is a way to increase stability of drug products. An overview of lyophilization technology would highlight the criticality of moisture control for lyo drugs. We will hence examine considerations for moisture control including study data to share some general findings.
Jia Min Boo, Technical Account Specialist, West Pharmaceuticals
Container Closure Integrity of Parenterals – Past, Present and Future
Andrea Simonetti, Director of Sales & Marketing, Pharma Inspection Equipment, Xepics