Advances in Continuous Active Pharmaceutical Ingredient (API) Manufacturing: Real-time Monitoring Using Multivariate Tools

被引:0
作者
Melanie Dumarey
Martin Hermanto
Christian Airiau
Peter Shapland
Hannah Robinson
Peter Hamilton
Malcolm Berry
机构
[1] GlaxoSmithKline,Product Development and Supply, Research and Development
[2] GlaxoSmithKline,Technical Development, Global Manufacturing Site
[3] GlaxoSmithKline,Product Development and Supply, Research and Development
来源
Journal of Pharmaceutical Innovation | 2019年 / 14卷
关键词
Multivariate statistical process monitoring; MSPM; Continuous manufacturing; PAT; Process monitoring; Multivariate analysis;
D O I
暂无
中图分类号
学科分类号
摘要
引用
收藏
页码:359 / 372
页数:13
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  • [1] Poechlauer P(2012)Continuous processing in the manufacture of active pharmaceutical ingredients and finished dosage forms: an industry perspective Org Process Res Dev 16 1586-1590
  • [2] Manley J(2012)Using continuous processes to increase production Org Process Res Dev 16 852-869
  • [3] Broxterman R(2017)Regulatory perspectives on continuous pharmaceutical manufacturing: moving from theory to practice September 26–27, 2016, International symposium on the continuous manufacturing of pharmaceuticals J Pharm Sci 106 3199-3206
  • [4] Gregertsen B(2011)Economic analysis of integrated continuous and batch pharmaceutical manufacturing: a case study Ind Eng Chem Res 50 10083-10092
  • [5] Ridemark M(2014)Regulatory and quality considerations for continuous manufacturing J Pharm Sci 104 803-812
  • [6] Anderson NG(2015)Modernizing pharmaceutical manufacturing: from batch to continuous production J Pharm Innov 10 191-199
  • [7] Nasr MM(2015)Control systems engineering in continuous pharmaceutical manufacturing J Pharm Sci 104 832-839
  • [8] Krumme M(2017)Using PAT to accelerate the transition to continuous API manufacturing Anal Bioanal Chem 409 821-832
  • [9] Matsuda Y(2015)Industry perspectives on process analytical technology: tools and applications in API development Org Process Res Dev 19 63-83
  • [10] Trout BL(2017)Development of a commercial flow Barbier process for a pharmaceutical intermediate Org Process Res Dev 21 317-326