KEYWORDS: Quality by Design, Active Pharmaceutical Ingredients.

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 process ...
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