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Whitepaper: Monocyte activation test (MAT)
For pharmaceutical companies, patient safety has always been the priority. That’s why pyrogen detection has become a mandatory Quality Control test for release of any parenteral drug.
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QA/QC
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Guide to Informatics & Data Integrity
In this edition, two companies showcase their services and highlight how they stand out from the crowd. The exponential speed of the information technology evolution is rapidly being accepted and integrated into our everyday life, yet it remains a challenge in the laboratory.
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Data integrity for cleanroom monitoring
With a continual focus on data integrity and helping our customers meet regulations while generating actionable insights, Particle Measuring Systems provides a complete range of products and services.
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Whitepaper: USP 643: the wrong end of the stick
To ensure that USP/EP standards are met, TOC of highly purified water can be determined by internal purification-process monitoring.
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QA/QC & Analytical Techniques In-Depth Focus 2019
Analytical techniques for QA/QC purposes are integral to the safe production of therapeutics. This in-depth focus looks at Raman spectroscopy for amorphous phase analysis and discusses the viable but non-culturable (VBNC) state of bacteria in environmental monitoring.
whitepaper
Whitepaper: Implications of the EU Biocidal Products Regulation 528/2012 for cleanroom disinfectants
Biocidal products manufactured in or imported into the EU or European Economic Area must be authorised for compliance with the requirements of the EU Biocidal Products Regulation (BPR) and any relevant national legislation before being placed on the market.
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Bioprocessing & Bioproduction In-Depth Focus 2019
The process of manufacturing a biotherapeutic drug entails numerous quality control measures to ensure safety and efficacy. The articles in this in-depth focus discuss higher order structure analysis and host cell protein contamination issues.
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Scientific Poster & Whitepaper Gallery 2019
The latest research and developments from Pharma and Biopharma industry experts.
whitepaper
Article: Elemental impurities: certified reference materials for ICH Q3D, USP<232> & <2232> and Ph.Eur. 5.20
Metallic contamination in drug products, referred to as elemental impurities, may arise from several sources.
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FDA plans to institutionalise drug compounding
The FDA has told its staff that it will be assigning drug compounding to the Office of Compliance.
whitepaper
Application note: Ultrapure water for LC-MS biomedical analyses
In this paper the suitability of reagent water for LC-MS biomedical analyses will be evaluated and the role of water quality in achieving sensitive and reliable LC-MS analyses will be discussed.
whitepaper
Whitepaper: Saving time and money in pharmaceutical operations
Having a holistic data infrastructure in place can not only save time by providing key real-time information and money through readily-accessible, enterprise-wide intelligence, it can also ensure stress-free operations.
whitepaper
Scientific poster: Nuvia aPrime 4A: a hydrophobic anion exchange resin for refined selectivity and recovery
The elimination of product and process related impurities is essential to the safety and efficacy of biopharmaceuticals.
news
Premier Pharmacy Labs recalls products after FDA inspection
The company has announced a recall of products which were intended to be sterile after a lack of sterility assurance.
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FDA joins blockchain system for drug safety
A multi-company system to improve traceability of pharmaceutical products is newly supported by the FDA.
