Biotech Products and the Challenge of Next Generation Cleaning Strategies
EMA (2014)[1] and PDA TR49 (2010)[2] clear up some cleaning validation aspects for therapeutic macromolecules, but do not provide any clear positions on acceptance limits definition.
To make it simple and based on scientific rationale, biotech procedures are deemed “self-cleaned” processes due to:
- denaturation (or degradation) products, generated by the cleaning process itself (high temperature and cleaning agents like surfactants, acidic or alkaline solutions play a relevant rule)
- several purification steps performed in the downstream to remove process impurities