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5 September 2014 | By Dr. John H. Kalivas, Editor for the Journal of Chemometrics and Applied Spectroscopy.
In the pharmaceutical industry, it is necessary to control, in a tight range, the active pharmaceutical ingredient (API) content of products, e.g., tablets or other powder blends.
5 September 2014 | By Dr. Stephen McGrath, Teva Pharmaceuticals Ireland (TPI)
Organisations are constantly striving to drive down costs while maintaining the quality of their products and services. In recent years, much has been written in both the academic and practitioner literature on the application of Lean principles for the elimination of waste and focusing of energies on value-creating activities.
5 September 2014 | By Ryan Gosselin & Nicolas Abatzoglou, Pfizer Industrial Research Chair, University of Sherbrooke / Philip Quinn, Pfizer Industrial Research Chair, University of Sherbrooke and Process Analytical Sciences Group, Pfizer Canada / Joanny Salvas & Jean-Sébastien Simard, Process Analytical Sciences Group, Pfizer Canada
Pharmaceutical product manufacturing is a conservative environment because of the obligations to abide by rigorous operation protocols aimed at insuring the highest possible product quality. A relatively recent initiativeguidance, from the U.S. FDA (Food and Drug Administration) has encouraged innovation and development of PATs (Process Analytical Technologies) for improved process…
As we see increased adoption of Raman Spectroscopy as the technique of choice for the rapid identification of materials, our guidelines tell you what you need to know...
In Issue #3 2014: Pharmaceutical freeze-drying, Self-amplifying mRNA vaccines, Polymorph myths, Microbiology focus, NMR for isotope profiling, Manufacturing with QbD 2.0, Single-cell mRNA-Sequencing, qPCR focus, Powder Flow...
An effective quality risk management (QRM) process ensures proactive identification and control of potential issues that may arise during development and commercialisation. Where quality is defined as the degree to which a set of intrinsic properties of a drug product, its underpinning manufacturing process, and any supporting processes fulfils the…
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.
Identification of materials using spectral libraries and other multivariate identification methods on hand-held Raman spectrometers has allowed for rapid non-destructive analysis and easy interpretation of results for non-technical users...
29 May 2014 | By TSI Inc.
This pharma webinar provides an overview of the new PHSS Bio-contamination Monograph and the value of real-time airborne viable particle detection in GMP classified areas.
In Issue #2 2014: Mass Spectrometry and Stem Cells in-depth focuses, Hot Melt Extrusion, PAT, Excipients, Microbiology plus much more...
15 April 2014 | By Jose Montenegro-Alvarado, Bradley Diehl, Jean-Maxime Guay, Steve Hammond, Hiwot Isaac, Ben Lyons, Conor McSweeney, Seamus O’Neill, Jean-Sébastien Simard and Joep Timmermans, Pfizer Inc.
This article reviews some emerging applications of Process Analytical Technologies (PAT) for packaging quality testing. Specifically, four commercially-available packaging applications are explored in further detail: Raman spectroscopy for rapid material identification testing of polymeric packaging materials; vision-based elastic deformation for non-destructive blister integrity testing; X-ray monitoring for inline blister fill…
In Issue #1 2014: Raman Spectroscopy in-depth focus, Ingredients, LIMS, Kinase, Near Infrared in-depth focus, RNA, Microbiology...
21 March 2014 | By METTLER TOLEDO
Take the worry out of weighing with new balances designed to aid compliance and process security...
B&W Tek, Inc., an advanced instrumentation company that delivers lab quality Raman spectroscopy solutions through user-friendly mobile platforms, is pleased to announce its newest strategic partnership with LabWare, Inc., the global leader of Laboratory Information Management Systems (LIMS) and instrument integration software products.
19 February 2014 | By Dr Xufeng Sun, Senior Research Scientist II, AMRI
Dr Xufeng Sun, Senior Research Scientist II at AMRI, discusses their SMARTSOURCING™ approach, looking particularly at the use of Raman technology...
