Monday, March 12, 2018 : 6:00 – 8:30pm (Dinner provided)

SC2: The Multi-Attribute Method (MAM) for Improving Product and Process Development

Instructors:
Richard Rogers, Ph.D., Scientist 4, Just Biotherapeutics

Introduction

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.

Course Outline:

• Introduction to the MAM

      1. Workflow
      2. Attribute analytics
            a. Relative quantification
      3. New peak detection
      4. Software
            a. For Process Development
            b. For QC
      5. MAM Consortium

• Attribute analytics using the NIST Mab

      6. Glycans
      7. Oxidations
      8. Deamidations
      9. C-terminal K

• New peak detection (differential analysis) using the NIST Mab

      10. Peptide spiked into NIST Mab
      11. pH 8 37C stressed NIST Mab

• Discussion with Q&A

Instructor Bio:
Dr. Rogers got his Ph.D. from the Johns Hopkins University in 2003. In Mike Matunis’ lab he studied the effects of Sumo modification on transcription factors. As a post doc, Dr. Rogers joined John Aitchison’s lab at the Institute for Systems Biology. At the ISB, Dr. Rogers expanded his research on post translational modification by applying mass spectrometry to detect phosphoryatlation and other ubiquitin-like modifications in macrophages. In 2012, Dr. Rogers joined the Analytical Sciences group at Amgen. At Amgen, Dr. Rogers developed a mass spectrometry based multi-attribute method (MAM) for biotherapeutic characterization and release from QC. Dr. Rogers is currently working for Just Biotherapeutics in Seattle. At Just, Dr. Rogers is continuing his work on the MAM.