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The use of QbD for peptide manufacturing processes

corresponding

ANDERS TSIRK1*, JON H. RASMUSSEN2
*Corresponding author
1. Global Development Manager,  PolyPeptide Group (PPL)
2. Global Development Director,  PolyPeptide Group (PPL)

INTRODUCTION
The introduction of QbD in the pharmaceutical industry (1-6) has been a key driver for creating the foundation for a new approach. The acceptance of a more science and risk-based approach has created the opportunity to employ techniques long existing in other industries, for instance, design for six sigma (DFSS) (7).
Peptide APIs are very different for several reasons: Sequence and difficulty, API volume requirements, indication, potency, OEL. However, for the majority of peptide APIs manufactured today some common denominators are:

  • More process steps (as compared to small molecules);
  • More process parameters;
  • High degree of repetition of similar process steps.


The use of QbD for peptide