Reference no: EM133410280

You are in the process of transferring a new lyophilized product for initial clinical production at a CMO. The CMO has passed a Quality Audit and there are no concerns with the design of the facility or supporting data for facility qualification and processes. Because of the unknowns of the CMO facility and equipment and your product, you are going to perform an engineering run. For the following steps, provide a KEY* outcome that you will test or monitor during the engineering run (1 point each). These outcomes should be related to process parameters and how they impact quality attributes.

KEY means something important to ensure that clinical production will yield material suitable for clinical use and is specific to that unit operation (and important for the success of that unit operation). For the purposes of this question, the answer supplied for each area should be different. These should be process related data and not facility.

Dilution of pooled drug substance to drug product concentration.