Monday, October 7, 2024 | 8:00 a.m.–4:00 p.m., US ET
USP Headquarters, 12601 Twinbrook Parkway, Rockville, MD 20852
Summary Notes | Presentations | Agenda
Overview:
This free hybrid event will convene experts from industry, regulatory bodies, and academia to explore the implications of subvisible silicone oil droplets on particle analysis, drug product safety, and process control. The discussion will focus on potential clinical risks posed to patients by these "silicone particles" and how analytical methodologies can be used to distinguish these particles from others.
Why Attend:
The round table is a joint-collaboration of USP Dosage Forms Expert Committee & the IQ Consortium that will facilitate an exchange of knowledge and strategies among stakeholders. Engage with experts from FDA’s CDER, IQ Consortium, and USP on subvisible silicone oil droplets, particle analysis, drug product safety, and process control to better understand and manage silicone particle-related challenges in pharmaceuticals.
Who Should Participate:
- Chemistry Manufacturing Control: including Drug Product Processing (Analytical, Formulation, Fill/Finish) and Device
- QA/QC staff in the pharmaceutical and allied industries
- Regulatory professionals
- Scientists with interest in Particulate Matter
- Clinicians, including toxicologists, patient safety, drug metabolism
Reference Articles:
- Saggu et al., Evaluating Clinical Safety and Analytical Impact of Subvisible Silicone Oil Particles in Biopharmaceutical Products, J. Pharm. Sci., 110, 1093-1102 (2024).
- Joh et al., Silicone Oil Particles in Prefilled Syringes With Human Monoclonal Antibody, Representative of Real-World Drug Products, Did Not Increase Immunogenicity in In Vivo and In Vitro Model Systems, J. Pharm. Sci., 109, 845-853 (2020).
For further information or to suggest additional stakeholder topics related to USP General Chapters please contact us at gc@usp.org.