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Key Sessions

Thomas De Vijlder

Analytical and Bioanalytical Strategies for Peptide Development and Manufacturing

Janssen, Belgium

09:00 - 09:10 10 mins
Chairperson’s Opening Remarks
  • Chairperson Bruce Morimoto - Vice President, Drug Development Operations, Alkahest, Inc
09:10 - 15:30 380 mins
Analytical and Bioanalytical Strategies for Peptide Development and Manufacturing
  • Thomas De Vijlder - Senior Scientist Mass Spectrometry, Janssen, Belgium
  • Dr. Viv Lindo - Associate Director, MedImmune

This multi speaker symposium will feature a series of case studies and group discussions focused on analytical and bioanalytical strategies for peptide development and manufacturing.

Some of the topics to be discussed include:

  • Analytical method development, validation and transfer for peptide therapeutics
  • Characterisation techniques, impurity identification and predicting stability in drug development and manufacturing of complex peptide therapeutics
  • Application of high resolution mass spectrometry for detecting and characterising peptide impurities
  • Development and regulatory acceptance of quality control strategy for peptide APIs
  • Analysis of starting materials in peptide manufacturing
  • Development and application of new analytical methods and technologies for peptides
  • Peptide therapeutics- bioanalytical challenges and lessons learned
  • Regulatory considerations for peptide impurities

Thomas De Vijlder, Senior Scientist Mass Spectrometry, Janssen Pharmaceutica, Belgium

Vivian Lindo, Associate Director, MedImmune

Analytical Challenges In The Development Of Therapeutic Peptides: How “Improved” Peptides Can Make The Life Of A Mass Spectrometrist Difficult – And What To Do About It?

Nowadays, therapeutic peptides in pharmaceutical development often contain modifications (cyclization, PEGylation, unnatural amino acids, etc.) to “improve” pharmacological properties. These improvements increase the complexity of mass spectrometry (MS)-based characterization. We show how different, tailor-made (bio)chemical and enzymatic approaches can be used to complement advanced MS-techniques. This is necessary to unveil essential information on peptide APIs, their process impurities and degradation products.

Thomas De Vijlder, Senior Scientist Mass Spectrometry, Janssen Pharmaceutica, Belgium

Towards Solving the Puzzle of Peptide Higher Order Structure (HOS)

  • Peptide critical quality attributes
  • Analytical testing to determine peptide HOS
  • Peptide isomerisation
  • Peptide self-association

Vivian Lindo, Associate Director, MedImmune

15:30 - 15:35 5 mins
End of Day 4 and EuroPeptides 2018