Coriolis CSO invited to speak at IFPAC 2021 Event
IFPAC - International Forum for Process Analysis & Control
The IFPAC is a leading conference in Process Analytical Technology (PAT), Process Analysis & Control, and Advanced Manufacturing Science. This year, the fully interactive event will include important research, technological advances, case studies, lessons learned, and the latest in regulatory guidance, standards & controls. For over 30 years, IFPAC has brought together experienced professionals & the next generation of leaders.
Coriolis CSO Dr. Andrea Hawe joins FDA-hosted session "Particles in Biologic Drug Products"
Dr. Andrea Hawe was invited to speak on Friday, March 5th about the "Application of Submicron and Micron Particle Analysis for the Development of Therapeutic Proteins and ATMPs". Alongside Dr. Andrea Hawe, a number of distinguished speakers in the field will be joining the session, which is chaired by Ashwinkumar Bhirde from the FDA.
Session Abstract: The presence of particles in parenteral drug products is a critical quality attribute that directly impacts the quality, efficacy, and safety of the product. Particles in drug products can be unintentional effects of product, process, packaging, or contamination. Particles are found in all classes of drugs, including biotechnology products, and biologics. The session will 1) discuss analytical methods to detect, identify, characterize, and classify particles in biologic drug products; 2) discuss the regulatory considerations in conducting product quality review with regard to particles; and 3) discuss common concerns regarding particles in biologic drug products regulated by FDA.
Register for the event - click here
Learn about Coriolis and our related services:
- Particle characterization
- Particle identification
- Advanced therapy medicinal products (ATMPs) – Biosafety level 2
- About Coriolis