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European Pharmacopoeia publishes new chapter regarding BET testing
The new chapter describes a method for bacterial endotoxins (BET) testing using recombinant factor C (rFC) instead of limulus amoebocyte lysate (LAL).
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On-demand webinar: Outsourcing selected areas of the quality system
Former MHRA inspector Rachel Carmichael discusses outsourcing areas of your quality system including what would drive this decision, aspects of the operation that can be supported and measures to facilitate the process
article
Comparison of health technology assessments and time to reimbursement for orphan drugs
This article delves into four health technology assessment agencies, analysing the opportunities and challenges for orphan drugs in France, Germany, England and Scotland.
Whitepapers/App Notes/Posters
Application note: Ozonia Ozone Technology for ultrapure water disinfection
Learn why Ozonia MEMBREL electrolytic ozone technology is the ultimate solution for ultrapure water disinfection applications.
Whitepapers/App Notes/Posters
Infographic: Benefits and applications of Ozone Technology
Learn the benefits of Ozonia MEMBREL electrolytic ozone technology in ultrapure water disinfection applications.
article
The impact of supply chain risks and LAL reliance
For over 30 years, pharmaceutical and medical device product release has relied solely on endotoxin assays using Limulus Amebocyte Lysate (LAL). This article addresses the potential risks associated with relying on a single raw material in a fragile supply chain and explores alternative testing options.
article
Raman imaging in pharmaceutical research – an overview
Since making its debut in the pharmaceutical setting, the range of applications for which Raman microscopy imaging has been used continues to grow. Here, Harald Fischer, Damon Strom, Miriam Boehmler, Eleni Kallis and Thomas Dieing demonstrate the versatility of confocal Raman imaging by exploring a variety of real-world applications.
article
Rapid microbiological methods: A looking glass into what and how we are
The impact of rapid microbiological methods (RMM) on the scientific community has been widespread and profound. Lucpah Nekati explains how their numerous benefits enable deeper understanding, faster and more easily.
Whitepapers/App Notes/Posters
Application note: Pharmaceutical analysis using UV-Vis: compliance with USP Chapter <857> and European pharmacopoeia (Ph. Eur. Chapter 2.2.25)
USP general chapter and Ph. Eur. chapter 2.2.25 guide instrument operational qualification protocols for UV-Vis spectroscopy. This technical note demonstrates how to ensure qualification of the Cary 3500 as per global pharmacopoeias' requirements.
Whitepapers/App Notes/Posters
Article: Analytical Quality by Design (AQBD) approach to support analytics optimisation strategy
Analytical procedures are necessary to develop products and manufacturing process, to measure critical quality attributes and to ensure the quality of final products.
news
bioBoaVista manufactures customised media for COVID nasal diagnostic tests using the Flexicon PF7
bioBoaVista showcases its viral transport medium, that can stabilise samples, for efficient nasal tests for the diagnosis of COVID-19.
news
Consortium established to monitor COVID-19 vaccines after marketing
A new consortium has been formed for the study of COVID-19 vaccines after their approval, to monitor their safety and efficacy.
news
EMA issues guidance on medicine impurities, in light of nitrosamine detection
After nitrosamines were detected in sartan medicines, the EMA has released new recommendations about handling and reporting impurities in drugs.
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How confident are you that your data is complete, secure and accurate?
Reliable data integrity tools to take control of your equipment and data.
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Application Notes & Whitepapers 2020
The latest applications and advice from industry experts.