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Sustainable analytical approach devised for complex drug formulation
The innovative method uses spectroscopy and could enhance pharmaceutical quality assurance in resource-limited settings, the study suggests.
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Chemometrics
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UV-based PAT could enable continuous protein purification
A multi-wavelength UV-based process analytical technology (PAT) could significantly reduce downstream protein purification timelines.
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Revised general chapter on chemometric methods available for comment
The revised general chapter 5.21 has been published in Pharmeuropa 33.3, the European Pharmacopoeia online forum, for public comment.
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Kaiser Optical Systems: Expert partners in Raman
Kaiser Optical Systems provides Raman analysers and fibre-optic probes for pharmaceutical applications ranging from laboratory discoveries to process control. Working with Kaiser is an opportunity to benefit from its experience and knowledge in Raman spectroscopy, chemometric model development, bioprocessing and pharmaceutical analysis.
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Guide to Analytical Equipment
In this edition, two leading analytical equipment suppliers explain how their products meet current industry requirements.
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ProCellics™ – first in-line and real-time bioprocess raman analyser
ProCellics™, first in-line and real-time bioprocess raman analyser, is a RESOLUTION Spectra Systems product. It offers a GMP user-friendly and easily deployed Process Analytical Technology (PAT) solution...
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Pharma development and manufacturing with QbD 2.0
3 July 2014 | By José Menezes, Institute of Biotechnology and Bioenginerring, IST, Universidade de Lisboa / Francisca Gouveia and Pedro Felizardo, 4Tune Engineering Ltd
Pharma and BioPharma industries are aware of the impact of production processes on sustainability of business operations. To improve performance, companies have recognised that it is necessary to better understand the drivers of both costs and revenues and the actions that can be put in place to address them.
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Issue #3 2013 – Digital version
Read the free digital version of the June / July edition of European Pharmaceutical Review magazine...
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Chemometrics: Implementing multivariate data analysis to monitor mammalian cell culture processes
13 June 2013 | By Payal Roychoudhury, formerly AstraZeneca and Ronan O’Kennedy, Fujifilm Diosynth Biotechologies and Jim Faulkner, GlaxoSmithKline and Brian McNeil & Linda M. Harvey, University of Strathclyde
Biopharmaceutical companies are constantly evaluating new methods for mammalian cell line development that offer benefits such as shorter time lines, improved consistency, higher monoclonal antibody (mAb) production, better genetic stability and increased flexibility. Each of these advantages extends a potentially large cost benefit to companies as their recombinant protein products…
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Intelligent Process Condition Monitoring for industrial tablet coating operation
18 December 2012 | By Jun Huang, Saly Romero-Torres, Liam Ryan and Mojgan Moshgbar, Pfizer Inc
This paper presents a feasibility study to develop an Intelligent Process Condition Monitoring (IPCM) system for providing a real time ‘health check’ for the tablet coating process in drug product manufacturing. The study fits well under the framework of Intelligent based Manufacturing (IbM) initiated at Pfizer, and intends to move…
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Implementing chemometrics in late stage development and manufacturing
26 April 2012 | By Geir Rune Flåten, former Chemometrician Leader in Global Manufacturing and Supply at GlaxoSmithKline
Chemometrics was defined as a research area in 1974 and developed rapidly through the following decades in parallel with the fast paced improvement in analytical technologies and computational power for lab instruments and sensors. Chemometrics is essentially the translation of measured signals characterising a sample or a process into meaningful…
