A Road Map to GMP Readiness for Protein Therapeutics – Drug Product Process Development for Clinical Supply

Biopharmaceuticals for human use present unique challenges during manufacturing, storage, shipment, and administration. Not all drug product process development aspects can and should be studied in detail before entering in first-in human studies (FIH) due to limited resources and the need for new drug candidates to enter phase I clinical studies quickly. Whilst activities for formulation development studies are well defined in literature, there is a lack of regulatory guidance for phase appropriate process development studies for clinical supplies. This review summarizes potential process development studies for liquid protein formulations and proposes a phase appropriate testing approach.