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On-demand webinar: What you need to know about USP <1085>
Watch the webinar that analyses the most important points introduced by the newest USP Chapter 1085 on endotoxin testing guideline and their impact.
List view / Grid view
QA/QC
webinar
Liquid-filled hard capsules: A flexible tool for rapid access to the clinic with poorly soluble and/or highly potent compounds
21 October 2020 | By Lonza Pharma & Biotech
Watch our on-demand webinar to learn about liquid-filled hard capsule technology has a proven record for addressing complex active pharmaceutical ingredient (API) formulation challenges, including bioavailability enhancement.
article
SGS experts help to mitigate the risk of nitrosamine impurities in drug products
The identification of N-nitrosodimethylamine (NDMA) in an active pharmaceutical ingredient (API) in 2018 not only led to regulatory warnings and product recalls, but wider recognition that pharmaceutical manufacturers should adopt a proactive approach to risk assessment and mitigation in relation to genotoxic contaminants.
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Expert view: The right endotoxin detection solution for you – bioMérieux’s complete portfolio of rFC endotoxin assays
As part of any general pyrogen testing strategy, the detection of even minute traces of the highly pyrogenic bacterial molecule called lipopolysaccharide (LPS, also named endotoxin) in pharmaceutical samples is mandatory to ensure patient safety.
news
Telstar’s centre in the UK consolidates its business growth with move to new higher-capacity modern installation
Specialised in aseptic and containment barrier Isolation technology systems, Telstar UK has seen increased demand for its products from all across the life sciences sector has grown significantly in the past few years.
news
Bioanalytical testing services market to become a $4.5 billion industry
A report found the rise in outsourcing, growing popularity of biologics and expanding acceptance of quality-by-design approaches would drive the market expansion.
whitepaper
Whitepaper: Streamlining pharma operations in the wake of COVID-19
Find out how to streamline your pharmaceutical operations in a COVID-19 environment.
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QA/QC & Analytical Techniques In-Depth Focus 2020
Read articles on validating rapid microbial methods according to regulatory requirements and how solid-state NMR spectroscopy can be used to analyse pharmaceuticals in this in-depth focus.
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European Pharmaceutical Review Issue 5 2020
In this issue you can find articles discussing the supply chain implications of Trump's 'Buy American' order, guidance on how to identify and justify starting materials for regulatory approval by both the EMA and FDA, as well as some of the latest developments in oral biologic drug delivery techniques. Also…
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Speeding processes and enhancing compliance with pharmacovigilance automation
Dr John Price explains how life sciences companies are making progress with pharmacovigilance automation and how a new study of pharmaceutical organisations has uncovered potential for improvement in the capture of adverse event data.
news
J&J pauses COVID-19 vaccine clinical trial after participant illness
J&J has paused its Phase III trial for its COVID-19 vaccine candidate following an unexplained illness in a study participant.
webinar
Pharmacopoeia changes – what to check for on UV/Vis spectrometers, and how.
12 October 2020 | By Mettler-Toledo GmbH and Hellma GmbH & Co. KG
Watch the on-demand webinar to learn about the important UV/Vis spectroscopy-relevant changes in both USP and Ph. Eur. taking a closer look at their impact and the solutions available to ensure compliance.
article
Reality check: is robotic process automation a panacea for transforming regulatory affairs?
Regulatory operations are burdened by resource-draining document and data processing tasks, but is robotic process automation the definitive solution? If not, where does it have greatest application and appeal – and how can life sciences firms exploit the full benefits? Agnes Cwienczek scrutinises the technology’s potential.
news
Using deep learning to predict drug metabolites and toxicity
Researchers have developed Metabolite Translator, a system that can predict what the in vivo metabolites of a drug could be in order to identify its potential toxicity.
webinar
Roadmap to compliance in environmental monitoring
5 October 2020 | By Merck KGaA
This on-demand webinar provides an overview of a holistic approach to achieve compliance with good manufacturing practice (GMP) requirements for environmental monitoring (EM) in aseptic manufacturing areas, such as ISO 5 cleanrooms in traditional setup, RABS or isolators.
