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Guide To Testing
In this edition of our ‘Guide to’ series, learn how these leading companies’ services and expertise can help you test your pharma/ biopharma products and medical devices.
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Rapid Microbiological Methods (RMMs)
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Industry experts combine to create safer intravenous delivery
The Italian Biochemical Institute, Comecer, and Particle Measuring Systems share expertise to develop and manufacture a safer intravenous solution...
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Whitepaper: Analytical criteria in bacterial endotoxin testing using LAL and rFC
This article covers the analytical criteria that apply to Bacterial Endotoxin Testing (BET) using Limulus Amebocyte Lysate (LAL) or recombinant Horseshoe crab Factor C (rFC) for the bioactivity determination of endotoxin in aqueous solutions, such as pharmaceuticals and medical device extracts. It explains the importance of these criteria for accurate…
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Applying quality risk management to develop an isolator filling line
11 February 2019 | By Particle Measuring Systems
Following the patent of the "Espresso" innovative infusion device, the Italian Biochemical Institute (IBI) "Lorenzini" commissioned Comecer to construct a new isolated filling line.
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Rapid microbiological methods and the regulatory environment
Rapid microbiological methods (RMM) continue to gain acceptance within our industry and a number of companies have already realised significant gains in detection sensitivity, automation, throughput, time-to-result and return on investment (ROI) when they have replaced their classical methods with these alternative technologies.
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Whitepaper: Why should you care about Burkholderia cepacia?
The Burkholderia cepacia complex (BCC) species are a group of gram-negative, rod-shaped bacteria that have been shown in recent years to be of concern for patients, and thus for manufacturers of drugs and products that contribute to patient health...
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Scientific Poster: Development of cGMP-Ready purification process for advenovirus purification
Large-scale downstream processing of viruses for clinical applications poses challenges different from those for many other biotherapeutics...
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Application note: Verification of pharmaceutical raw materials using the Spectrum Two N FT-NIR Spectrometer
In this application note, PerkinElmer describes how the Spectrum Two N™ FT-NIR spectrometer can be deployed using a workflow approach, suitable for a regulated environment, to overcome a range of different challenges in raw material identification...
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The regulatory acceptance of rapid microbiological methods
In the last issue of European Pharmaceutical Review (vol 22, issue 2), Jeanne Moldenhauer suggested the pharmaceutical industry has moved at a “snail’s pace” in terms of implementing rapid microbiological methods (RMM).
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Issue #3 2017 – Digital version
In Issue #3 2017: In-Depth Focuses covering Raman Spectroscopy, Separations & Purifications, Formulation Development & Delivery; Guide To Testing Services; GMP and mutual recognition; Regulatory Insight; RMMs; Microbiology Series; and much more...
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Microbiology In-Depth Focus 2017
In this Microbiology In-Depth Focus: Endotoxin masking hold-time study performance parameters; Microbiological monitoring pharmaceutical water systems; The rush to rapid microbiological methods - or not; and an expert view with Charles River Laboratories...
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Issue #6 2016 – Digital version
Read the free-to-view digital version of the latest issue of European Pharmaceutical Review...
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RMMs In-Depth Focus
In this RMMs In-Depth Focus: the role of statistical analysis in validating rapid microbiological methods; considerations when using RMMs for use in pharmaceutical microbiology; & RMMs roundtable...
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Wickham Labs to Exhibit at Pharmig 2016
3 November 2016 | By Wickham Laboratories Limited
Wickham Laboratories will be on Stand 8 at the 24th Annual Pharmig Conference in the Nottingham Belfry Hotel, November 16th & 17th...
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Microbiology: In-Depth Focus 2016
In this Microbiology In-Depth Focus: Risk-based microbiological testing; Improving microbiological assurance for bioburden testing; Microbiology Roundtable...
