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Case study and application of process analytical technology (PAT) towards bioprocessing: II. Use of ultra‐performance liquid chromatography (UPLC) for making real‐time pooling decisions for process chromatography
Author(s) -
Rathore Anurag S.,
Wood Rebecca,
Sharma Ashutosh,
Dermawan Shinta
Publication year - 2008
Publication title -
biotechnology and bioengineering
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.136
H-Index - 189
eISSN - 1097-0290
pISSN - 0006-3592
DOI - 10.1002/bit.21982
Subject(s) - bioprocess , pooling , chromatography , high performance liquid chromatography , process (computing) , process engineering , process analytical technology , chemistry , biochemical engineering , computer science , engineering , artificial intelligence , chemical engineering , operating system
Process analytical technology (PAT) has been gaining a lot of momentum in the biopharmaceutical community due to the potential for continuous real‐time quality assurance resulting in improved operational control and compliance. Two of the key goals that have been outlined for PAT are “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”. Recently, we have been examining the feasibility of applying different analytical tools for designing PAT applications for bioprocessing. We have previously shown that a commercially available online high performance liquid chromatography (HPLC) system can be used for analysis that can facilitate real‐time decisions for column pooling based on product quality attributes (Rathore et al., 2008). In this article we test the feasibility of using a commercially available ultra‐ performance liquid chromatography (UPLC) system for real‐time pooling of process chromatography columns. It is demonstrated that the UPLC system offers a feasible approach and meets the requirements of a PAT application. While the application presented here is of a reversed phase assay, the approach and the hardware can be easily applied to other modes of liquid chromatography. Biotechnol. Bioeng. 2008;101: 1366–1374. © 2008 Wiley Periodicals, Inc.