Process analytical technology (PAT) for biopharmaceutical products: Part II. Concepts and applications.
Implementing real-time product quality control meets one or both of the key goals outlined in FDA's PAT guidance: "variability is managed by the process" and "product quality attributes can be accurately and reliably predicted over the design space established for materials used, process parameters, manufacturing, environmental, and other conditions." The first part of the paper presented an overview of PAT concepts and applications in the areas of upstream and downstream processing. In this second part, we present principles and case studies to illustrate implementation of PAT for drug product manufacturing, rapid microbiology, and chemometrics. We further present our thoughts on how PAT will be applied to biotech processes going forward. The role of PAT as an enabling component of the Quality by Design framework is highlighted. Integration of PAT with the principles stated in the ICH Q8, Q9, and Q10 guidance documents is also discussed.
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E K
EK
CDER, FDA, Silver Spring, Maryland, USA.
Shah
R B
RB
Riley
B S
BS
Park
J T
JT
Brorson
K A
KA
Rathore
A S
AS
D001709:Biotechnology / Q000379:methods* / Q000592:standards*; D018929:Cell Culture Techniques / Q000379:methods / Q000592:standards; D004345:Drug Industry / Q000592:standards; D005612:Freeze Drying / Q000379:methods / Q000592:standards; D008828:Microbiological Techniques / Q000379:methods / Q000592:standards; D011786:Quality Control; D019265:Spectroscopy, Near-Infrared / Q000379:methods; D013059:Spectrum Analysis, Raman / Q000379:methods; D014481:United States; D014486:United States Food and Drug Administration