Control and Determination of Visible and Sub-visible Particulate Matter in Biologics
Regulations direct drug product manufacturers to exclude foreign matter and minimize foreign particle content. Particles can originate from the environment, packaging materials, formulation ingredients, interactions between product and packaging, or be inherent to the product. For inherent species, or the expected formulation-related particle species, which techniques may be most appropriate? This workshop will be a forum for discussing the control and determination of undesired visible and sub-visible particulate matter and also characterization of inherent particle species in biopharmaceuticals.
- Gain insight into the USP standard process and how to work with USP to impact future standards.
- Obtain feedback about the current chapters and where gaps exist for future standard work.
- Identify areas where USP can broaden our scope in the biologics space.
Who Should Participate?
- Analytical chemists and biologists
- QA/QC analysts
- R&D scientists, managers
- Manufacturing scientists, managers
- Regulatory affairs specialists
- Contract research organizations
- Contract manufacturing organizations
Workshop Steering Committee
- Scott Aldrich, Ultramikro, LLC
- Mohammad Heidaran, U.S. Food & Drug Administration
- Ewa Marszal, U.S. Food & Drug Administration
- Anthony Mire-Sluis, AstraZeneca
- John Shabushnig, Insight Pharma Consulting LLC
- Darin Weber, Medeor Therapeutics
- Wesley Workman, Pfizer
- Earl Zablackis, Sanofi Pasteur
- Kevin Carrick, USP
- Desmond Hunt, USP
- Maura Kibbey, USP
Call for Abstracts
Interested in submitting an abstract for the workshop? We want to hear from you! Click here for topics and submission instructions.