Continuous Manufacturing is Here to Stay (PDA/FDA Joint Regulatory Conference 2023)
Kelley Burridge, PhD, Product Quality Team Leader, OBP, OPQ, CDER, U.S. FDA, discusses the importance of continuous manufacturing for the future.
In part of the session "Continuous Manufacturing and Publication of ICH Q13" at the PDA/FDA Joint Regulatory Conference, Kelley Burridge, PhD, Product Quality Team Leader, OBP, OPQ, CDER, U.S. FDA, discusses the importance of continuous manufacturing for the future.
Burridge: Continuous manufacturing is here. An evolution of pharmaceutical quality over the last several decades started with adoption of risk based approaches, as this analytical Technology and Quality by design have set the stage for adoption of continuous manufacturing. What's needed for approval of continuous manufacturing packages is the same as what's needed for batch processes. A demonstration of pharmaceutical quality demonstrate that you understand your product and your process and that you have the capability to operate a well controlled process, consistent with manufacturer's quality guide.
FDA Approves Pfizer Combination Regimen for Treating R/R Diffuse Large B-Cell Lymphoma
February 14th 2025The approval of an ADCETRIS combination regimen is based on positive data from a Phase III trial where the combination regimen demonstrated a clinically meaningful reduction in the risk of death.
