Choose Wisely

By John Dobiecki, Microtest Laboratories With more than 25 years of experience in contract aseptic fill/finish (F/F) manufacturing, contract bulk drug manufacturing, and aseptic F/F outsourcing of bulk drug product, I have identified a number of pitfalls that tend to trip up potential clients during their search processes. In this article, I will discuss common oversights and how to remedy or avoid them. It should come as no surprise that the first step involves putting together a Request for Proposal (RFP) that will be presented to potential contract aseptic F/F sites. The importance of this step is highlighted by the fact that a quick Internet search using the keywords “RFP, Pharmaceutical Outsourcing, and Manufacturing” will yield over 70,000 listings of papers and seminars explaining the details and how-to’s of RFPs. However, for the sake of this paper, putting together an RFP for contract aseptic processing should, at minimum, detail the following: The key word in the preceding paragraph is detail. In many cases, when details are improperly given in an RFP, processing problems will result. The most prevalent error at this stage involves providing unintentional misinformation about the process and/or product in the RFP. For example, let’s consider a product destined for use in a Phase I clinical trial. Up to this point, the majority of manufacturing effort and cost has been spent on developing synthetic routes for the API or, in the case of biopharmaceuticals, looking for ways of expressing and purifying the active biologic. A significant amount of time and money also has been spent on evaluating additional parameters (e.g., efficacy, profile studies and formulation issues). A critical mistake is to present this limited history in the RFP as if it were the definitive process or history. Remember, a good contract aseptic F/F site will have the necessary experience