Webinar:

Forced Degradation Studies & LC-MS Multi-attribute Monitoring

Sponsored by: Covance

Focused on:

  • Product Degradation
  • Bio Therapeutics

Date: 12 February

47

Time: 3PM London/10AM New York

Forced degradation studies, where a putative drug substance or drug product is subjected to elevated chemical and environmental stress, are a regulatory requirement. These studies serve to identify and understand product degradation pathways and potential impact on efficacy or safety, as well as to challenge the sensitivity and specificity of analytical methods from the development stage onwards.

These studies are made more challenging by the lack of defined procedures in regulatory guidance for most of the required degradation conditions, with those procedures that are defined often being too severe for biotherapeutics. Therefore, Covance is developing a standardised forced degradation strategy, resulting in defined degradation conditions and timepoints, with analysis using the most appropriate analytical methods for the stress conditions applied.

LC-MS multi-attribute monitoring (MAM) is an integral component of the forced degradation strategy developed. This analytical approach, which Covance has developed in line with GMP regulatory standards, allows assessment of various product characteristics in one assay, reducing overall testing requirements, and is suitable for use to support batch release and formal stability assessments.

This presentation will detail Covance's approach to such studies and feature a comprehensive, demonstrative data set.

Presented by

Rachel Smith,

Assay Development Scientist - Mass Spectrometry, Covance

Following a PhD at the University of York in small molecule analysis by mass spectrometry, using platforms including MALDI-MS, LC-MS and GC-MS, Rachel joined Covance biopharmaceutical CMC solutions in 2016. As a member of the mass spectrometry assay development team she has developed workflows for intact and middle-up LC-MS characterisation of mAbs and derivative fusion proteins, as well as gaining experience in other biopharmaceutical characterisation methods including peptide mapping and released N-glycan analysis. Whilst at Covance, Rachel has also taken on a key role in the planning and development of forced degradation studies.

Key Learning Objectives

  • Learn how LC-MS peptide mapping workflows can be used across the entire development continuum, including GMP batch and stability testing.
  • See how Covance has demonstrated the specificity for MAM LC-MS for detecting degradative events, compared to the traditional chromatographic and electrophoretic methodologies.
  • Find out how to implement a systematic forced degradation strategy; establish stress conditions, time courses and sample numbers, and confirm appropriate stability indicating analytical methods.

Audience

  • Quality Control
  • Quality Analytics
  • Compliance
  • Manufacturing Control
  • Manufacturing Quality
  • Formulation
  • CMC Program Management
  • CMC External Supply
  • CMC Leader
  • CMC Regulatory Affairs
  • Analytical CMC Specialist
  • QA CMC
  • CMC Consultant
  • CMC Biologics
  • CMC Pharmaceutical Analysis
  • CMC Development
  • CMC Policy
  • Biotech CMC
  • Biopharm CMC