Campbell Informatics has recently completed a prestigious 12-month research contract on behalf of FDA’s Office of Pharmaceutical Science.

 The assignment was led by Cliff Campbell CEO, and addressed the issue of changing sterile manufacturing sites from the point of view of both synthetic and biotech drug products, using terminal sterilization and aseptic processing platforms respectively.

 Its key finding is that the use of an approved Comparability Protocol under existing regulation and guidance is a feasible approach and that industry is encouraged to avail of this option. In summary, the Comparability Protocol will contain a detailed description of the proposed site changes, a summary of the studies to be performed to show that sterility assurance will not be compromised as a result of the change, and the acceptance criteria for these studies that must be obtained prior to distribution of the product. Once the Comparability Protocol has been approved, the studies conducted, and the acceptance criteria met, the product can be distributed. FDA will then be notified, via data summary within the firm’s subsequent Annual Report, that the criteria of the approved Comparability Protocol have been met.

The assignment was subject of a successful PDA/FDA Workshop in Washington DC on 16^th Sep ’09.