Process analytical technology (PAT) for biopharmaceutical products: Part I. concepts and applications
- 3 September 2009
- journal article
- research article
- Published by Wiley in Biotechnology & Bioengineering
- Vol. 105 (2), 276-284
- https://doi.org/10.1002/bit.22528
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. Biotechnol. Bioeng. 2010; 105: 276–284. Published 2009 Wiley Periodicals, Inc.Keywords
This publication has 30 references indexed in Scilit:
- Predicting sporulation events in a bioreactor using an electronic noseBiotechnology & Bioengineering, 2008
- At‐line monitoring of bioreactor protein production by surface plasmon resonanceBiotechnology & Bioengineering, 2007
- On‐line near infrared monitoring of glycerol‐boosted anaerobic digestion processes: Evaluation of process analytical technologiesBiotechnology & Bioengineering, 2007
- Open-loop control of the biomass concentration within the growth phase of recombinant protein production processesJournal of Biotechnology, 2006
- On-line Measurements and Control of Viable Cell Density in Cell Culture Manufacturing Processes using Radio-frequency ImpedanceCytotechnology, 2006
- Normal‐flow virus filtration: detection and assessment of the endpoint in bioprocessingBiotechnology and Applied Biochemistry, 2005
- Bracketed generic inactivation of rodent retroviruses by low pH treatment for monoclonal antibodies and recombinant proteinsBiotechnology & Bioengineering, 2003
- Automated flow cytometry for acquisition of time‐dependent population dataCytometry Part A, 2003
- PEGylated antibodies and antibody fragments for improved therapy: a reviewAdvanced Drug Delivery Reviews, 2002
- Inline characterization of cell concentration and cell volume in agitated bioreactors using in situ microscopy: Application to volume variation induced by osmotic stressBiotechnology & Bioengineering, 2002