Consultants' Network
Consultants' Network
Working Through Case Studies with Consulting Colleagues | March 24, 2025 | 8:00 PDT
Join Featured Speakers Mark Schenerman, CMC Biotech-MAS Consulting, University of Maryland, Baltimore County, and St John Skilton, Protein Metrics, LLC.
Register by March 21, 2025.
Consultants are a key component of CASSS membership. The purpose of the CASSS Consultants' Network is to facilitate discussions among consultants.
For more information, contact Anne Ornelas.
Abstract
Investigative Case Studies in Biopharmaceutical Quality Control and Mass Spectrometry
This program explores biopharmaceutical QC and mass spectrometry through real-world case studies.
1. Investigative Team Simulation:
• Objective: Address a QC observation on the stability profile of a monoclonal antibody.
• Activities: Brainstorm root causes, conduct experiments, identify the true cause, and determine CAPAs.
2. Mass Spectrometry in Biopharma:
• Objective: Understand mass spectrometry's role and limitations.
• Case Study 1: Analyze a biosimilar candidate that required re-engineering due to overlooked evidence.
• Case Study 2: Examine inconsistent mass spectrometry data in biologics.
Learning Outcomes:
• Develop problem-solving skills in QC.
• Gain insights into mass spectrometry applications.
• Understand the importance of context and assumptions in analysis.
• Learn to mitigate risks through effective CAPAs.
*Program Abstract created using AI from speakers' individual abstracts, approved by organizers.
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