The use of QbD for peptide manufacturing processes
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 manufacturing processes
This combination lends itself very well to a platform technology thinking where both in-silico analyses and empirical knowledge will guide and drive the development of processes for new APIs. New learning and discoveries will be fed back into the platform, and will increase further the predictability capabilities of it.
Within PPL, the QbD/ DFSS ...
