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Dear Group,
In view of FDA rejecting the deadline extension request for nitrosamine risk assessments for APIs and drug products, what is your view on risk assessment for biological products including monoclonal antibodies? Though FDA guidance for control of nitrosamine impurities in human drugs mandates risk assessment to be focused on chemically synthesized APIs, EU assessment report on the same doesn't rule out possibility of contamination of biological products by nitrosamines. The EU assessment also acknowledges that the risk to biological products is minimal and focused on products which contains chemically synthesized fragments, biologicals using processes where nitrosating reagents are deliberately added, or those packaged in certain primary packaging material, such as blister packs containing nitrocellulose.
Though the risk of formation of nitrosamines in biologicals during manufacturing process is negligible, should a similar declaration be obtained from raw material suppliers? would greatly appreciate the community's view on this.
Thanks you very much