Monday, March 12, 2018 : 6:00 – 8:30pm
SC1: Particles in Biotherapeutics: Characterization & Impact - Detailed Agenda
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, MS, PMP, CMC Project Manager, Pipeline Management, MedImmune
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.
SC2: The Multi-Attribute Method (MAM) for Improving Product and Process Development - Detailed Agenda
Richard Rogers, Ph.D., Scientist 4, Just Biotherapeutics
During biotherapeutic development, it is necessary to monitor properties of the therapeutic molecule and formulation that have been identified as critical quality attributes (CQAs) for product safety and efficacy. In particular, the industry is seeking
to monitor post-translational modifications (PTMs), glycosylation profiles, and excipients with both UV and mass data by implementing multi-analyte or so-called Multi Attribute Methods (MAMs). The course offers hands-on training on how to apply
the Multi-Attribute Method (MAM) to mass spectrometry data. We will be performing attribute analytics (quantifying product quality attributes) and new peak detection (purity test) on mass spec data. During the course, we will discuss the uses
of the MAM in process development and in a QC lab.
Wednesday, March 14, 2018 : 6:00 – 8:30pm
SC3: Critical Quality Attributes and Testing Strategy for Biotherapeutics Development - Detailed Agenda
Christine Chan, Ph.D., Principal Scientist & Senior Manager, Global Manufacturing Sciences & Technology, Sanofi
Biotherapeutics are challenging to develop due to complexity of the molecular structure as well as the manufacturing process. Identification of product critical quality attributes (CQAs) is an important component in the development of a robust
control strategy using the Quality-by-Design approach. In this short course, we will discuss the key concepts of CQA risk ranking based on potential impact on safety and efficacy, defining control strategies, the common analytical characterization
technologies used, and the considerations for development of an integrated testing strategy.