Considering a typical Drug Product manufacturing process from Drug Substance to a formulated product (tablet), for each step, describe what you consider might be the important quality attributes worthy of measurement and potential PATs could can be used. In either case, you should also comment on the challenges the pharma industry faces today regarding implementing PATs?

Most manufacturing strategies today include some level of support from an outsourcing service provider such as a CMO or contract testing lab. There has been a great deal of discussion regarding the elevated role these providers play in the drug development process. Today’s CMO is likely to not only execute critical development activities but also provide insight based upon their own experiences with multiple processes.

Biologic drug development consists of two fundamental components: the drug substance (DS) development, which can include the master and working cell bank development, manufacturing process development, and scale-up; and the drug product (DP) development, which includes the filling of the drug substance into the primary container. If the primary container is a medical device, such as a prefilled syringe, there is an additional step where the final drug product is placed into the final packaging tray or system to form the final combination product. While the FDA does not explicitly define the testing required as a product moves through its development life cycle, recognized standards provide guidance based upon where you are in your drug development and clinical program. Let’s focus on the considerations for building a testing strategy for a drug product when using a CMO.