Tuesday, February 2, 2021 | 10:00 AM 1:00 PM(US ET)

Instructors:

Dean Ripple, PhD, Supervisory Physicist, Bioprocess Measurements Group, National Institute of Standards and Technology

Srivalli Telikepalli, PhD, Research Chemist, Biomolecular Measurement Division, National Institute of Standards and Technology

Workshop Description:
This short course will give an introduction to current issues surrounding particle formation and 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.

Topics to be Covered:

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

Speaker Biographies:

Dean Ripple, PhD, Supervisory Physicist, Bioprocess Measurements Group, National Institute of Standards and Technology

Dean received a Ph.D. from Cornell University in 1991. After a successful career at NIST developing methods and standards in thermometry, in 2010, he became Leader of the Bioprocess Measurements Group, which conducts research supporting biomanufacturing and health care. His own research focuses on new standards and methods for characterizing protein particulates. Dr. Ripple has presented workshops on measurement issues to many industrial groups, ranging from petroleum producers to vaccination program coordinators. He is an active member of the NCSLI Healthcare Metrology subcommittee, the ASTM committee on the Manufacture of Pharmaceutical Products, and expert panels of the US Pharmacopeia. In recognition of his contributions, he has received awards from the U.S. Department of Commerce, ASME, and ASTM committee E20 on Temperature Measurement.

Srivalli Telikepalli, PhD, Research Chemist, Biomolecular Measurement Division, National Institute of Standards and Technology

Dr. Telikepalli received a B.A. degree in Chemistry at Cornell University in 2008, and a Ph.D. in Pharmaceutical Chemistry from the University of Kansas in 2014. Her graduate work was focused on understanding the formation of protein aggregates/particles, their characterization, and their possible correlations to immunogenic responses. In 2014, she started working as a Research Chemist at the National Institute of Standards and Technology. She has contributed to the development of the NIST Monoclonal Antibody Reference Material and a subvisible protein-like particle reference material. Her work focuses on developing protein-like particle standards that enable more robust characterization of proteinaceous particles in biotherapeutics. She received a U.S. Department of Commerce Gold Medal Award in 2017 for her contributions.