A schedule of events for Protein Aggregation Measurement in Biotherapeutics: Established and Emerging Techniques is provided below for the convenience of conference attendees.
This one-day conference scheduled for Monday, December 5, 2016, will be held at the University of Maryland School of Pharmacy, located at 20 N. Pine Street in Baltimore, Md.
The conference will focus on analytical technologies for protein aggregation, with an emphasis on sub-visible particles. Both established and emerging technologies will be presented and discussed.
For a printable version of the conference agenda, please download this document.
| Time | Activity |
|---|---|
| 8:00-8:30 a.m. | Attendee Arrival and Registration |
| 8:30-9:00 a.m. |
Welcome and Introduction |
| Session 1: Overview of Regulatory Challenges and Analytical Technologies Chair: Rukman De Silva, PhD, Chemist, Division of Biotechnology Review and Research IV, FDA/CDER/OPQ/OBP |
|
| 9:00-9:20 a.m. | Scientific and Regulatory Perspectives on Measuring Protein Aggregation of Biotechnology Products Ashutosh Rao, PhD Laboratory Chief CDER/OPQ/OBP/DBRIII Food and Drug Administration |
| 9:20-9:40 a.m. | Submicron Particle Characterization and Benchmarking Under Biologics Leadership Group of the IQ Consortium Mario Hubert, PhD Principal Scientist Bristol Myers Squibb |
| 9:40-10:00 a.m. | Critical Evaluation of the Emerging Analytical Methods for Characterization of Sub-visible Particles Atanas Koulov, PhD Head, Analytical Development & QC Lonza AG |
| 10:00-10:30 a.m. | Panel Discussion |
| 10:30-11:00 a.m. | Coffee Break |
| Session 2: Applications and Limitations of Common Technologies Chair: Brian Lobo, PhD, Associate Director and Group Leader, Formulation Sciences Department, MedImmune/AstraZeneca |
|
| 11:00-11:20 a.m. | Size Exclusion Chromatography of Biologicals: Truth or Fiction? Christina Vessely, PhD Senior Consultant Biologics Consulting |
| 11:20-11:40 a.m. |
Practical Application of Analytical Tools for Characterization of an Impurity-related Particle Formation Mechanism |
| 11:40-12:00 p.m. | Generalized Method for Subvisible Particles Classification and Counting Using Flow Microscopy and Random Forests Miguel Saggu, PhD Scientist Genentech |
| 12:00-12:30 p.m. | Panel Discussion |
| 12:30-1:30 p.m. | Lunch |
| Session 3: Optical Techniques -- Counting and Characterization Chair: Dean Ripple, PhD, Leader, Bioprocess Measurements Group, National Institute of Standards and Technology |
|
| 1:30-1:50 p.m. | Holographic Characterization of Protein Aggregates David Grier, PhD Director, Center for Soft Matter Research New York University |
| 1:50-2:10 p.m. | Estimation of Protein Aggregate Density Using Sedimentation Combined with Micro-particle Tracking Richard Cavicchi, PhD Physicist National Institute of Standards and Technology |
| 2:10-2:30 p.m. | Achieving Absolute Particle Sizing with Flow Cytometry Reema Raghavendra, PhD Scientist II AbbVie |
| 2:30-3:00 p.m. | Panel Discussion |
| 3:00-3:30 p.m. | Break |
| Session 4: NMR and MS Techniques Chair: Thomas Spitznagel, PhD, Vice President of Development, Macrogenics |
|
| 3:30-3:50 p.m. | Applications of NMR for Assessing the Higher Order Structure of Protein Therapeutics David Keire, PhD Acting Laboratory Chief Office of Pharmaceutical Quality Center for Drug Evaluation and Research Food and Drug Administration |
| 3:50-4:10 p.m. | Water NMR for Protein Aggregation Characterization Marc Taraban, PhD Research Assistant Professor Department of Pharmaceutical Sciences University of Maryland School of Pharmacy |
| 4:10-4:30 p.m. | Characterization of Aggregation Propensities of Protein Therapeutics by Hydrogen/Deuterium Exchange Mass Spectrometry Richard Y. Huang, PhD Research Investigator II Bristol Myers Squibb |
| 4:30-5:00 p.m. | Panel Discussion |