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QA/QC & Analytical Techniques In-Depth Focus 2020
Within this in-depth focus are features on the uses of Raman imaging in the pharmaceutical industry and the benefits of utilising rapid microbiological methods (RMM).
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Rapid Microbiological Methods (RMMs)
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European Pharmaceutical Review Issue 3 2020
In this issue is a discussion on the promise of virally vectored DNA and mRNA vaccines to combat COVID-19 as well as articles on how packaging could help to ensure patient adherence, regulatory issues for medicines and diagnostics during the pandemic and the benefits of digitalising the pharmaceutical supply chain.…
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Whitepaper: Does QRM + RMM = Better EM
Facilities perform environmental monitoring (EM) to demonstrate a state of control.
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Do viability methods detect all viable organisms?
Many bacterial species have been found to exist in a viable but non-culturable state. Jeanne Moldenhauer discusses this phenomenon and makes suggestions as to why we don’t often see an increase in viable cells when using viability-based methods.
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On-demand webinar: Streamline your Rapid Microbiological Method Validation
When it comes to microbial contamination testing, false results can waste valuable time.
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Nelson Labs: supporting internal quality processes
Nelson Labs has a long history of partnering with pharmaceutical and biopharmaceutical companies. We perform a variety of testing to support your internal quality processes including: sterility (USP 71) testing in a cleanroom for isolator environment, particulates testing (USP 787, 788) using a variety of methods, bacterial endotoxin, filter validations,…
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Charles River microbial solutions
Those who work in QC know that the job is more than a box to be checked, and that it can’t be done effectively without confidence in the reported results. Tight timelines, regulatory demands, and stringent data integrity standards can make it hard to focus on what’s really at stake…
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Microbiology In-Depth Focus 2019
The work of a pharmaceutical scientist requires precision, attention to detail and is of vital importance to the safety of products and ultimately patients. This section features insights from experienced scientists who’ve worked extensively in microbiological analysis, developing tests, methods and standards that help establish a foundation for the production…
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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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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...
