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Issue #1 2016 – Digital edition
In Issue #1 2016: Regulation, Drug Delivery, Raman, PAT, Formulation, NIR, Microbiology, and much more...
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Process Analytical Technologies (PAT)
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The application of skip testing to drug substance manufacture
29 February 2016 | By Phil Borman, Simon Bate and Keith Freebairn, GlaxoSmithKline
Skip testing is a process employed to reduce the analytical drugs testing burden and lends itself to processes with high frequency batch production. Rather than test all batches within a given interval, pre-selected batches are assessed and the other batches ‘skipped’. This reduction is justified as it is shown that…
whitepaper
Application Note: MicroNIR PAT for blend monitoring
The aim of Quality by Design (QbD) is to build quality into a product and process from the outset. The pharmaceutical and related industries utilise powder blending operations to make solid dose drugs, yet the phenomena of powder mixing is the least understood of all sciences.
whitepaper
Application note: In-line PAT solutions for understanding and controlling fluidised bed granulation (FBG) processes
Determining CPP’s in DoE using Eyecon particle characteriser and Multieye Multipoint NIR.
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Issue #6 2015 – Digital edition
In digital version of Issue #6 2015: Microbiology, Screening, PCR, Continuous Manufacturing, PAT, Regulation, and much more...
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PAT In-Depth Focus 2015
Featuring an overview of process analytical control; Beyond API monitoring: in-line Raman spectroscopy for process control; Monitoring, understanding and assessing pharmaceutical process and product quality; and a PAT roundtable...
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Issue #5 2015 – Digital edition
In Issue #5 2015: Counterfeit Drugs, Regulatory Insight, Raman In-Depth Focus, PAT Series, Polymorphs, RMM In-Depth Focus, Particle Sizing, Freeze Drying, and much more...
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Continuous flow processing in the pharma industry – an unstoppable trend?
22 October 2015 | By Bernhard Gutmann and Christian Oliver Kappe, University of Graz
Continuous flow processes have many distinct advantages over discontinuous batch production and therefore, in the last century, continuous operation has become by far the most dominant form of production for high-volume and low-cost materials such as petrochemical and commodity chemicals. The first applications of continuous processes in the pharmaceutical industry…
webinar
Fit-for-purpose miniature NIR spectroscopy for solid dosage manufacturing
14 October 2015 | By Viavi Solutions Inc.
This webinar discusses how miniaturised spectrometers facilitate testing of different control schemes with the goal of enabling real-time feedback control of continuous manufacturing processes...
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Issue #4 2015 – Digital edition
In Issue #4 2015: NGS, Informatics, Spray Drying, Excipients, Rapid Methods, NIR, PAT, Regulatory Insight and much more...
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PAT Series: Predictive monitoring and control approaches in biopharmaceutical manufacturing
3 September 2015 | By Cenk Undey, Tony Wang, Bryan Looze, Yingying Zheng and Myra Coufal - Amgen
Predictive monitoring is a key feature of biopharmaceutical manufacturing; making predictions about the key process end points such as process performance indicators or quality attributes using a process model offers the unique advantages of process improvement and optimisation, and helps give insights into variability.
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Issue #3 2015 – Digital edition
In Issue #3 2015: Regulatory Insight, Microfluidics, PCR in-depth focus, Drug Delivery, Content Uniformity, HPLC, Microbiology in-depth focus, NMR, PAT and much more...
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PAT Series: Applicability of process analytical tools to bioprocessing trends
3 July 2015 | By Payal Roychoudhury, PhD, formerly AstraZeneca
The past decade has been a period of unparalleled change and development in the fermentation industry. As the nature of this industry evolves, and in particular, with the increasing prominence of the new biopharmaceuticals (therapeutic proteins, diagnostic enzymes and monoclonal antibodies) the need for effective bioprocess monitoring grows in importance1.
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Issue #2 2015 – Digital edition
In Issue #2 2015: Outsourcing, Drug pricing reforms, Stem Cells in-depth focus, Microbiology series, Environmental monitoring, LC-MS in-depth focus, Manufacturing solutions, PAT series and much more...
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Real-time biological particle counting in environmental monitoring
The methods for monitoring air in cleanroom environments: viable counting techniques (settle plates and biological air samplers) and particle counters, are long established technologies and have been widely used in pharmaceutical manufacturing environments for decades. Although innovations have taken place with both particle counters and biological air samplers, primarily in…
