Drug discovery and the scale-up of newly developed manufacturing processes represent an exciting and dynamic field for academic scientists, startups, and small to large pharmaceutical companies. The scale-up to clinical batch sizes, in particular, poses challenges as lab-scale manufacturing expands to batch sizes in the multi-kg range, requiring further optimization of manufacturing processes. Due to the limited and often unknown safety profiles of new compounds, this scale-up is conducted in specialized facilities equipped with adequate contingency measures.
To ensure patient safety, a key issue in the manufacture of active pharmaceutical ingredients (APIs) in multi-purpose, multi-product manufacturing equipment is the adequate management of potential (cross-)contamination, especially when the product portfolio includes both developmental and commercial manufacturing processes.
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