Sander Van Gessel, MEng, Business Unit Director, DFE Pharma, discusses the recent findings of nitrosamine impurities in human drugs as a part of his session, “Reducing Nitrosamines Without the Use of Scavengers: The Critical Role of Excipients - An Excipient Manufacturer’s View.”
To take the pharma as an example, we’ve studied the nitrosamine levels in our excipients, and they’re all below two ppb parts per billion. (Part-1)
In the manufacturing drugs, the drying process is an inherent part of wet granulation techniques that a lot large part of the industry uses, and we think that next steps can be taken by going, transferring to dry granulation or directing. (Part-2)
For reference, his previous presentation in FDA and the Center for Research on Complex Generics (CRCG) hosted a public workshop on June 15, 2023 is as follows;
Reducing Nitrosamines Without the Use of Scavengers: The Critical Role of Excipients–An Excipient Manufacturer’s View
