title: Process analytical technology (PAT) for biopharmaceutical products: Part I. concepts and applications.
abstract: Process analytical technology (PAT) has been gaining momentum in the biotech community due to the potential for continuous real-time quality assurance resulting in improved operational control and compliance. In this two part series, we address PAT as it applies to processes that produce biotech therapeutic products. In the first part, we address evolution of the underlying concepts and applications in biopharmaceutical manufacturing. We also present a literature review of applications in the areas of upstream and downstream processing to illustrate how implementation of PAT can help realize advanced approaches to ensuring product quality in real time. In the second part, we will explore similar applications in the areas of drug product manufacturing, rapid microbiology, and chemometrics as well as evolution of PAT in biotech processing.
authors.affiliation: CDER, FDA, Silver Spring, Maryland, USA.
authors.forename: E K
authors.initials: EK
authors.lastname: Read
authors.forename: J T
authors.initials: JT
authors.lastname: Park
authors.forename: R B
authors.initials: RB
authors.lastname: Shah
authors.forename: B S
authors.initials: BS
authors.lastname: Riley
authors.forename: K A
authors.initials: KA
authors.lastname: Brorson
authors.forename: A S
authors.initials: AS
authors.lastname: Rathore
mesh_terms: D001709:Biotechnology / Q000379:methods* / Q000592:standards*; D018929:Cell Culture Techniques / Q000379:methods; D002845:Chromatography / Q000379:methods; D003470:Culture Media / Q000737:chemistry; D005374:Filtration / Q000295:instrumentation / Q000379:methods; D005434:Flow Cytometry / Q000379:methods; D011092:Polyethylene Glycols / Q000737:chemistry; D011506:Proteins / Q000737:chemistry; D011786:Quality Control
chemical_list: D003470:Culture Media; D011506:Proteins; D011092:Polyethylene Glycols