{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,7]],"date-time":"2026-09-07T13:08:52Z","timestamp":1788786532225,"version":"build-2803163510"},"reference-count":31,"publisher":"Elsevier BV","license":[{"start":{"date-parts":[[2026,10,1]],"date-time":"2026-10-01T00:00:00Z","timestamp":1790812800000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/www.elsevier.com\/tdm\/userlicense\/1.0\/"},{"start":{"date-parts":[[2026,10,1]],"date-time":"2026-10-01T00:00:00Z","timestamp":1790812800000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/www.elsevier.com\/legal\/tdmrep-license"},{"start":{"date-parts":[[2026,8,10]],"date-time":"2026-08-10T00:00:00Z","timestamp":1786320000000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/"}],"content-domain":{"domain":["elsevier.com","sciencedirect.com"],"crossmark-restriction":true},"short-container-title":["Journal of Chromatography A"],"published-print":{"date-parts":[[2026,10]]},"DOI":"10.1016\/j.chroma.2026.467347","type":"journal-article","created":{"date-parts":[[2026,8,10]],"date-time":"2026-08-10T15:03:52Z","timestamp":1786374232000},"page":"467347","update-policy":"https:\/\/doi.org\/10.1016\/elsevier_cm_policy","source":"Crossref","is-referenced-by-count":0,"special_numbering":"C","title":["High-throughput microscale chromatography for process characterization and control strategy development in biologics manufacturing"],"prefix":"10.1016","volume":"1786","author":[{"given":"Kamiyar","family":"Rezvani","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0009-0001-5562-238X","authenticated-orcid":false,"given":"Claire","family":"Hoff","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Daniel","family":"Torrico","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Andrew","family":"Smith","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"John Patrick","family":"Mpindi","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-2163-9773","authenticated-orcid":false,"given":"Christopher","family":"Thompson","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Steven","family":"Evans","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kelcy","family":"Newell","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Matthew","family":"Aspelund","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-5557-0284","authenticated-orcid":false,"given":"Xuankuo","family":"Xu","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"78","reference":[{"key":"10.1016\/j.chroma.2026.467347_bib0001","doi-asserted-by":"crossref","first-page":"605","DOI":"10.1002\/bit.21904","article-title":"High-throughput screening of chromatographic separations: I. Method development and column modeling","volume":"100","author":"Coffman","year":"2008","journal-title":"Biotechnol. Bioeng."},{"key":"10.1016\/j.chroma.2026.467347_bib0002","doi-asserted-by":"crossref","first-page":"927","DOI":"10.1002\/jctb.2125","article-title":"Review: microscale methods for high-throughput chromatography development in the pharmaceutical industry","volume":"84","author":"Chhatre","year":"2009","journal-title":"J. Chem. Technol. Biotechnol."},{"key":"10.1016\/j.chroma.2026.467347_bib0003","doi-asserted-by":"crossref","first-page":"127","DOI":"10.1016\/j.tibtech.2010.12.001","article-title":"High-throughput process development for biopharmaceutical drug substances","volume":"29","author":"Bhambure","year":"2011","journal-title":"Trends Biotechnol."},{"key":"10.1016\/j.chroma.2026.467347_bib0004","doi-asserted-by":"crossref","first-page":"403","DOI":"10.1002\/btpr.1705","article-title":"Chromatography process development in the quality by design paradigm I: establishing a high-throughput process development platform as a tool for estimating \u201ccharacterization space\u201d for an ion exchange chromatography step","volume":"29","author":"Bhambure","year":"2013","journal-title":"Biotechnol. Prog."},{"key":"10.1016\/j.chroma.2026.467347_bib0005","doi-asserted-by":"crossref","first-page":"94","DOI":"10.1016\/j.chroma.2015.09.038","article-title":"Use of MiniColumns for linear isotherm parameter estimation and prediction of benchtop column performance","volume":"1418","author":"Keller","year":"2015","journal-title":"J. Chromatogr. A"},{"key":"10.1016\/j.chroma.2026.467347_bib0006","doi-asserted-by":"crossref","first-page":"1273","DOI":"10.1002\/bit.25901","article-title":"High throughput chromatography strategies for potential use in the formal process characterization of a monoclonal antibody","volume":"113","author":"Petroff","year":"2016","journal-title":"Biotechnol. Bioeng."},{"key":"10.1016\/j.chroma.2026.467347_bib0007","doi-asserted-by":"crossref","first-page":"73","DOI":"10.1016\/j.chroma.2017.05.041","article-title":"Optimization of a micro-scale, high throughput process development tool and the demonstration of comparable process performance and product quality with biopharmaceutical manufacturing processes","volume":"1506","author":"Evans","year":"2017","journal-title":"J. Chromatogr. A"},{"key":"10.1016\/j.chroma.2026.467347_bib0008","doi-asserted-by":"crossref","first-page":"626","DOI":"10.1002\/btpr.1905","article-title":"A practical strategy for using miniature chromatography columns in a standardized high-throughput workflow for purification development of monoclonal antibodies","volume":"30","author":"Welsh","year":"2014","journal-title":"Biotechnol. Prog."},{"key":"10.1016\/j.chroma.2026.467347_bib0009","doi-asserted-by":"crossref","DOI":"10.1016\/j.chroma.2023.464391","article-title":"A comprehensive assessment of the applicability of RoboColumn as a chromatography scale-down model for use in biopharmaceutical process validation","volume":"1710","author":"Chinn","year":"2023","journal-title":"J. Chromatogr. A"},{"key":"10.1016\/j.chroma.2026.467347_bib0010","doi-asserted-by":"crossref","DOI":"10.1002\/btpr.2870","article-title":"Scale-down model qualification of ambr\u00ae 250 high-throughput mini-bioreactor system for two commercial-scale mAb processes","volume":"35","author":"Manahan","year":"2019","journal-title":"Biotechnol. Prog."},{"key":"10.1016\/j.chroma.2026.467347_bib0011","doi-asserted-by":"crossref","first-page":"1623","DOI":"10.1002\/btpr.2162","article-title":"Application of high-throughput mini-bioreactor system for systematic scale-down modeling, process characterization, and control strategy development","volume":"31","author":"Janakiraman","year":"2015","journal-title":"Biotechnol. Prog."},{"key":"10.1016\/j.chroma.2026.467347_bib0012","doi-asserted-by":"crossref","first-page":"893","DOI":"10.1002\/ceat.200800167","article-title":"High throughput screening for the design and optimization of chromatographic processes \u2013 Miniaturization, automation and parallelization of breakthrough and elution studies","volume":"31","author":"Wiendahl","year":"2008","journal-title":"Chem. Eng. Technol."},{"key":"10.1016\/j.chroma.2026.467347_bib0013","doi-asserted-by":"crossref","first-page":"1192","DOI":"10.1002\/biot.201100475","article-title":"High-throughput process development of chromatography steps: advantages and limitations of different formats used","volume":"7","author":"\u0141\u0105cki","year":"2012","journal-title":"Biotechnol. J."},{"key":"10.1016\/j.chroma.2026.467347_bib0014","doi-asserted-by":"crossref","first-page":"723","DOI":"10.1002\/btpr.1533","article-title":"High-throughput methods for miniaturization and automation of monoclonal antibody purification processes","volume":"28","author":"Treier","year":"2012","journal-title":"Biotechnol. Prog."},{"key":"10.1016\/j.chroma.2026.467347_bib0015","doi-asserted-by":"crossref","DOI":"10.1016\/j.chroma.2021.462696","article-title":"Understanding the effects of system differences for parameter estimation and scale-up of high throughput chromatographic data","volume":"1661","author":"Keller","year":"2022","journal-title":"J. Chromatogr. A"},{"key":"10.1016\/j.chroma.2026.467347_bib0016","doi-asserted-by":"crossref","first-page":"154","DOI":"10.1016\/j.chroma.2017.07.091","article-title":"Understanding operational system differences for transfer of miniaturized chromatography column data using simulations","volume":"1515","author":"Keller","year":"2017","journal-title":"J. Chromatogr. A"},{"key":"10.1016\/j.chroma.2026.467347_bib0017","doi-asserted-by":"crossref","first-page":"1503","DOI":"10.1002\/btpr.2363","article-title":"Development of pseudo-linear gradient elution for high-throughput resin selectivity screening in RoboColumn \u00ae format","volume":"32","author":"Kiesewetter","year":"2016","journal-title":"Biotechnol. Prog."},{"key":"10.1016\/j.chroma.2026.467347_bib0018","doi-asserted-by":"crossref","first-page":"54","DOI":"10.1016\/j.chroma.2019.01.063","article-title":"Prediction of lab and manufacturing scale chromatography performance using mini-columns and mechanistic modeling","volume":"1593","author":"Benner","year":"2019","journal-title":"J. Chromatogr. A"},{"key":"10.1016\/j.chroma.2026.467347_bib0019","doi-asserted-by":"crossref","DOI":"10.1016\/j.chroma.2022.463658","article-title":"Demonstration of continuous gradient elution functionality with automated liquid handling systems for high-throughput purification process development","volume":"1687","author":"Rezvani","year":"2023","journal-title":"J. Chromatogr. A"},{"key":"10.1016\/j.chroma.2026.467347_bib0020","doi-asserted-by":"crossref","first-page":"26","DOI":"10.1038\/nbt0109-26","article-title":"Quality by design for biopharmaceuticals","volume":"27","author":"Rathore","year":"2009","journal-title":"Nat. Biotechnol."},{"key":"10.1016\/j.chroma.2026.467347_bib0021","doi-asserted-by":"crossref","first-page":"306","DOI":"10.1016\/j.biologicals.2016.06.004","article-title":"Process characterization and design space definition","volume":"44","author":"Hakemeyer","year":"2016","journal-title":"Biologicals"},{"key":"10.1016\/j.chroma.2026.467347_bib0022","unstructured":"ICH, Q8(R2): pharmaceutical development, current step 4 version, August 2009, (n.d.)."},{"key":"10.1016\/j.chroma.2026.467347_bib0023","doi-asserted-by":"crossref","first-page":"480","DOI":"10.4161\/mabs.2.5.12645","article-title":"Recovery and purification process development for monoclonal antibody production","volume":"2","author":"Liu","year":"2010","journal-title":"mAbs"},{"key":"10.1016\/j.chroma.2026.467347_bib0024","series-title":"Process Scale Purification of Antibodies","first-page":"343","article-title":"Development of a platform process for the purification of therapeutic monoclonal antibodies","author":"Li","year":"2017"},{"key":"10.1016\/j.chroma.2026.467347_bib0025","series-title":"Generalized Linear models : With Applications in Engineering and the Sciences","author":"Myers","year":"2010"},{"key":"10.1016\/j.chroma.2026.467347_bib0026","series-title":"JMP For Mixed Models","author":"Hummel","year":"2021"},{"key":"10.1016\/j.chroma.2026.467347_bib0027","doi-asserted-by":"crossref","DOI":"10.1021\/ac053390m","article-title":"Beyond the t-test: statistical equivalence testing","volume":"77","author":"Limentani","year":"2005","journal-title":"Anal. Chem."},{"key":"10.1016\/j.chroma.2026.467347_bib0028","doi-asserted-by":"crossref","first-page":"657","DOI":"10.1007\/BF01068419","article-title":"A comparison of the two one-sided tests procedure and the power approach for assessing the equivalence of average bioavailability","volume":"15","author":"Schuirmann","year":"1987","journal-title":"J. Pharmacokinet. Biopharm"},{"key":"10.1016\/j.chroma.2026.467347_bib0029","series-title":"Guidance For Industry: Statistical Approaches to Establishing Bioequivalence, Draft Guidance, Center for Drug Evaluation and Research (CDER)","year":"2022"},{"key":"10.1016\/j.chroma.2026.467347_bib0030","doi-asserted-by":"crossref","first-page":"5416","DOI":"10.1021\/ac500497n","article-title":"Microchip zone electrophoresis for high-throughput analysis of monoclonal antibody charge variants","volume":"86","author":"Wheeler","year":"2014","journal-title":"Anal. Chem."},{"key":"10.1016\/j.chroma.2026.467347_bib0031","doi-asserted-by":"crossref","DOI":"10.1016\/j.chroma.2023.463809","article-title":"An automated, low volume, and high-throughput analytical platform for aggregate quantitation from cell culture media","volume":"1691","author":"Lambiase","year":"2023","journal-title":"J. Chromatogr. A"}],"container-title":["Journal of Chromatography A"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/api.elsevier.com\/content\/article\/PII:S0021967326006758?httpAccept=text\/xml","content-type":"text\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/api.elsevier.com\/content\/article\/PII:S0021967326006758?httpAccept=text\/plain","content-type":"text\/plain","content-version":"vor","intended-application":"text-mining"}],"deposited":{"date-parts":[[2026,9,7]],"date-time":"2026-09-07T12:21:23Z","timestamp":1788783683000},"score":1,"resource":{"primary":{"URL":"https:\/\/linkinghub.elsevier.com\/retrieve\/pii\/S0021967326006758"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2026,10]]},"references-count":31,"alternative-id":["S0021967326006758"],"URL":"https:\/\/doi.org\/10.1016\/j.chroma.2026.467347","relation":{},"ISSN":["0021-9673"],"issn-type":[{"value":"0021-9673","type":"print"}],"subject":[],"published":{"date-parts":[[2026,10]]},"assertion":[{"value":"Elsevier","name":"publisher","label":"This article is maintained by"},{"value":"High-throughput microscale chromatography for process characterization and control strategy development in biologics manufacturing","name":"articletitle","label":"Article Title"},{"value":"Journal of Chromatography A","name":"journaltitle","label":"Journal Title"},{"value":"https:\/\/doi.org\/10.1016\/j.chroma.2026.467347","name":"articlelink","label":"CrossRef DOI link to publisher maintained version"},{"value":"article","name":"content_type","label":"Content Type"},{"value":"\u00a9 2026 The Author(s). Published by Elsevier B.V.","name":"copyright","label":"Copyright"}],"article-number":"467347"}}