Monday, March 12, 2018 : 6:00 – 8:30pm (Dinner provided)
SC1: Particles in Biotherapeutics: Characterization & Impact
Instructors:
Dean Ripple, Ph.D., Supervisory Physicist, Bioprocess Measurements Group, National Institute of Standards and Technology
Srivalli Telikepalli, Ph.D., Research Chemist, Biomolecular Measurement, National Institute of Standards and Technology
Maryam Mazaheri, M.S., PMP, CMC Project Manager, Pipeline Management, Medimmune
Introduction
This short course will give an introduction to current issues surrounding particle formation & characterization in biotherapeutics. Regulatory expectations provide the context of why particle loads are characterized and controlled. The basics of why and how proteins can aggregate will be presented along with a discussion of other particle types. An overview of the recent technology to accurately characterize various classes of aggregates and particles will be discussed. Studies from the current literature will be used to highlight various key points throughout the course.
Course Outline:
1. Introduction to Protein Aggregates & Other Particles
- Overview of particles in biotherapeutics: protein aggregates & other types
- Current regulatory expectations
- Rationale for characterization & control
- Recent experiences & case studies
2. Causes & Mechanisms behind Aggregation/Particle Formation
- Causes of protein aggregation
- Mechanisms behind formation of aggregates
- Sources of other types of particles
- Methods to minimize aggregation & particle formation
- Case studies
3. Technologies & Tools for Measuring & Characterizing Aggregates & Particles
- Visible particles (manual and automated inspection)
- Sub-visible particles (Microflow imaging, light obscuration, etc.)
- Sub-micrometer aggregates (Size exclusion SEC, AUC, FFF, etc.)
- Approaches to standardize particle counts
- Comparisons between technologies regarding limits of detection
4. Strategies for Particle Control & Characterization
5. Discussion with Q&A