Regulatory Challenges Of Continuous Biomanufacturing

Andrew Papas, NSF Health Sciences Pharma Biotech Consulting


The interaction with regulatory agencies on the biomanufacturing of therapeutic proteins, mAbs, or other large molecules occurs throughout the drug development of the biologic; it begins with the original IND, accelerates at the licensing phase and continues throughout the product’s life cycle. There are many regulatory challenges along this journey.

Because of uniqueness of continuous biomanufacturing, one challenge that occurs throughout the product’s lifecycle is the inevitable change in Agency product reviewers who many times need to be educated on the nuances of your process or have a different opinion or expectation on how things should be done. As such, sponsors should be patient, include more detailed background information in interactions with the Agency, and welcome agency meetings, as needed. A few examples will be presented.

Another challenge includes how the sponsor approaches process validation, particularly if two or more parallel bioreactors are utilized and the downstream process draws from all upstream sources. This can affect future manufacturing changes, tech transfers, comparability schemes, and scheduling maintenance. This presentation will include examples that will illustrate this point as well as others.