Assessment of Recent Process Analytical Technology (PAT) Trends: A Multiauthor Review

被引:332
作者
Simon, Levente L. [1 ]
Pataki, Hajnalka [2 ]
Marosi, Gyoergy [2 ]
Meemken, Fabian [3 ]
Hungerbuehler, Konrad [3 ]
Baiker, Alfons [3 ]
Tummala, Srinivas [4 ]
Glennon, Brian [5 ,6 ]
Kuentz, Martin [7 ]
Steele, Gerry [8 ]
Kramer, Herman J. M. [9 ]
Rydzak, James W. [10 ]
Chen, Zengping [11 ]
Morris, Julian [12 ]
Kjell, Francois [13 ]
Singh, Ravendra [14 ]
Gani, Rafiqul [14 ]
Gernaey, Krist V. [14 ]
Louhi-Kultanen, Marjatta [15 ]
O'Reilly, John [16 ]
Sandler, Niklas [17 ]
Antikainen, Osmo [18 ]
Yliruusi, Jouko [18 ]
Frohberg, Patrick [19 ]
Ulrich, Joachim [19 ]
Braatz, Richard D. [20 ]
Leyssens, Tom [21 ]
von Stosch, Moritz [22 ,23 ]
Oliveira, Rui [22 ,23 ]
Tan, Reginald B. H. [24 ,25 ]
Wu, Huiquan [26 ]
Khan, Mansoor [26 ]
O'Grady, Des [27 ]
Pandey, Anjan [27 ]
Westra, Remko [28 ]
Delle-Case, Emmanuel [29 ]
Pape, Detlef [30 ]
Angelosante, Daniele [30 ]
Maret, Yannick [30 ]
Steiger, Olivier [30 ]
Lenner, Miklos [30 ]
Abbou-Oucherif, Kaoutar [31 ]
Nagy, Zoltan K. [31 ,32 ]
Litster, James D. [31 ]
Kamaraju, Vamsi Krishna [5 ,25 ]
Chiu, Min-Sen [25 ]
机构
[1] BASF Schweiz AG, CH-4133 Schweizerhalle, Switzerland
[2] Budapest Univ Technol & Econ, Dept Organ Chem & Technol, H-1111 Budapest, Hungary
[3] ETH, Dept Chem & Appl Biosci, CH-8093 Zurich, Switzerland
[4] Bristol Myers Squibb Co, Chem Dev, New Brunswick, NJ 08903 USA
[5] Univ Coll Dublin, Sch Chem & Bioproc Engn, Synth & Solid State Pharmaceut Ctr, Dublin 4, Ireland
[6] APC Ltd, Dublin 4, Ireland
[7] Univ Appl Sci & Arts Northwestern Switzerland, Inst Pharma Technol, Sch Life Sci, CH-4132 Muttenz, Switzerland
[8] PharmaCryst Consulting Ltd, Loughborough LE11 3HN, Leics, England
[9] Delft Univ Technol, Intensified React & Separat Syst, NL-2628 CB Delft, Netherlands
[10] GlaxoSmithKline, King Of Prussia, PA 19406 USA
[11] Hunan Univ, Coll Chem & Chem Engn, State Key Lab Chemo Biosensing & Chemometr, Changsha 410082, Hunan, Peoples R China
[12] Newcastle Univ, Sch Chem Engn & Adv Mat, Ctr Proc Analyt & Control Technol, Newcastle Upon Tyne NE1 7RU, Tyne & Wear, England
[13] Siemens Nv Sa, Ind Automat SIPAT Ind Software, B-1070 Brussels, Belgium
[14] Tech Univ Denmark DTU, Dept Chem & Biochem Engn, CAPEC PROC, DK-2800 Lyngby, Denmark
[15] Lappeenranta Univ Technol, Dept Chem Technol, FI-53851 Lappeenranta, Finland
[16] Roche Ireland Ltd, Clarecastle, Clare, Ireland
[17] Abo Akad Univ, Dept Biosci, Pharmaceut Sci Lab, FIN-20520 Turku, Finland
[18] Univ Helsinki, Fac Pharm, Div Pharmaceut Technol, SF-00100 Helsinki, Finland
[19] Univ Halle Wittenberg, Ctr Engn Sci, D-06099 Halle, Saale, Germany
[20] MIT, Cambridge, MA 02139 USA
[21] Catholic Univ Louvain, Inst Condensed Matter & Nanosci, B-1348 Louvain La Neuve, Belgium
[22] Univ Nova Lisboa, EQUIMTE Dept Quim, Fac Ciencias & Tecnol, P-1099085 Caparica, Portugal
[23] HybPAT, Caparica, Portugal
[24] ASTAR, Inst Chem & Engn Sci, Singapore 627833, Singapore
[25] Natl Univ Singapore, Dept Chem & Biomol Engn, Singapore 117576, Singapore
[26] US FDA, Div Prod Qual Res, Off Testing & Res, Off Pharmaceut Sci,Ctr Drug Evaluat & Res, Silver Spring, MD 20993 USA
[27] Mettler Toledo AutoChem, Columbia, MD 20146 USA
[28] FMC Technol BV, NL-6825 MN Arnhem, Netherlands
[29] Univ Tulsa, Tulsa, OK 74104 USA
[30] ABB Corp Res Ctr, CH-5405 Baden, Switzerland
[31] Purdue Univ, Sch Chem Engn, W Lafayette, IN 47906 USA
[32] Loughborough Univ Technol, Dept Chem Engn, Loughborough LE11 3TU, Leics, England
基金
欧洲研究理事会; 芬兰科学院; 中国国家自然科学基金; 英国工程与自然科学研究理事会;
关键词
NEAR-INFRARED SPECTROSCOPY; BATCH COOLING CRYSTALLIZATION; MEDIATED POLYMORPHIC TRANSFORMATION; BEAM REFLECTANCE MEASUREMENT; MODEL-PREDICTIVE CONTROL; ATR-FTIR SPECTROSCOPY; METASTABLE ZONE WIDTH; L-GLUTAMIC ACID; IN-SITU RAMAN; DIFFUSING-WAVE SPECTROSCOPY;
D O I
10.1021/op500261y
中图分类号
O69 [应用化学];
学科分类号
081704 ;
摘要
This multiauthor review article aims to bring readers up to date with some of the current trends in the field of process analytical technology (PAT) by summarizing each aspect of the subject (sensor development, PAT based process monitoring and control methods) and presenting applications both in industrial laboratories and in manufacture e.g. at GSK, AstraZeneca and Roche. Furthermore, the paper discusses the PAT paradigm from the regulatory science perspective. Given the multidisciplinary nature of PAT, such an endeavour would be almost impossible for a single author, so the concept of a multiauthor review was born. Each section of the multiauthor review has been written by a single expert or group of experts with the aim to report on its own research results. This paper also serves as a comprehensive source of information on PAT topics for the novice reader.
引用
收藏
页码:3 / 62
页数:60
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