Selecting An Aseptic Fill/Finish Contract Manufacturer: Avoiding The Most Common Mistakes

By Microtest Laboratories, Inc.

There have been many seminars and papers whose topic focuses on the proper selection process for choosing a Contract Manufacturing Organization (CMO). This paper focuses specifically on the unique steps involved in selecting and working with an aseptic processing CMO to produce injectable Final Drug Product (FDP). In addition to providing guidance on the selection process, common mistakes made by potential clients will also be discussed. These common oversights and their remedies are sourced from a collective experience base that covers contract aseptic Fill/Finish (F/F) manufacturing, contract bulk drug manufacturing, and aseptic F/F outsourcing of bulk drug product.

RFP - THE FIRST STEP
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 involving 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 minimally should detail the following:

• Description of the Final Drug Product and its intended use.
• Project scope (i.e., is the project just Fill/Finish? Will testing, stability studies, and/or development work be included?)
• The proposed aseptic manufacturing sequence.
• Any special "considerations" (e.g., thermal, light, shear sensitivities that the product may have, incompatibilities with certain materials, etc.).
• The required number of vials.
• The expected date the product is needed
• Testing requirements
• Stability
• Shipping

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