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In this in-depth focus, find out about the key points to consider when implementing new software in the pharma development space and the current positions of the EMA and FDA with regards to nitrosamine contaminants.
Endotoxin automation using microfluidics enables simpler, compliant processes for pharma QC, QA, validation and IT. BET assay setup is simplified and less LAL is required.
In this journal, features on the current regulatory positions on nitrosamine impurities, how investing in off-patent medicines can help drive innovation and why new regulations could lead to a biosimilar boom in the UK. Other articles include an exploration of the challenges in developing and delivering lipid nanoparticle mRNA-based vaccines,…
Endotoxin automation doesn’t mean complex instrumentation and setup. See how microfluidics enables easy BET assay setup so QC labs achieve high throughput with less hands-on time.
A rapid sterility test method that can be validated as quickly and confidently as it provides test results.
From traditional LAL assays to cartridge-based systems, robotics and microfluidic BET automation, learn how different endotoxin testing systems work in this infographic.
21 May 2021 | By Thermo Fisher Scientific
In this on-demand webinar, you will hear directly from industry auditors as they discuss the current regulatory framework for good manufacturing practice (GMP), including data integrity, validation and qualification for computerised systems in regulated laboratories.
Automated endotoxin testing is achieved in a compact platform, leveraging microfluidic liquid handling. QC labs simplify BET with easier, compliant assays using less LAL.
In this article, Shannon Flynn outlines six of the key risks threatening pharmaceutical manufacturers’ recovery from COVID-19 in 2021.
The International Coalition of Medicines Regulatory Authorities (ICMRA) and WHO are calling on pharma to provide voluntary unrestricted access to trial results data.
Rama Rao, CEO of Bloqcube, discusses the benefits of blockchain-based systems for clinical trials and how their implementation could revolutionise drug development.
Challenges and solutions to adopting MALDI technology for filamentous fungi ID with emphasis on sample preparation and database development.
12 April 2021 | By Charles River Laboratories
Watch this on-demand webinar with Jordi Iglesias to learn how you can improve the data integrity of your microbiological QC assays.
The Pistoia Alliance's Data Governance Community of Interest will develop best practices and advance digital transformation in the pharma/life sciences industry.
The life sciences industry may have been slower than other markets to appreciate the benefits of holistic data and document management, but that is changing rapidly now. Here, life sciences data and content management visionaries Steve Gens of Gens & Associates, Remco Munnik of Iperion and James Kelleher of Generis…
