news
Amneal recalls Metformin Hydrochloride Extended Release Tablets to consumer level
The voluntary recall of Metformin Hydrochloride Extended Release Tablets, 500mg and 750mg is due to unacceptable levels of NDMA impurities.
List view / Grid view
QA/QC
article
Preventing contamination during biopharmaceutical production
A study that analysed QA/QC incidents at several biomanufacturing plants has revealed how companies can best hope to detect and mitigate virus contamination.
whitepaper
Application note: Detection of contamination from gloves
This application note shows the detection of low numbers of different bacterial test strains from Neoprene® gloves.
news
Global regulatory authorities COVID-19 policy and regulations meeting
Global pharma regulators met to discuss measures to ensure supply continuity, flexible regulatory policies and their expectations for COVID-19 clinical trials.
news
Simple but effective: an experimental nanoparticle COVID-19 test
Researchers reveal their experimental test can detect the presence of COVID-19 RNA in a sample in 10 minutes, and in a way that does not require trained personnel to interpret.
webinar
Accelerated development of first-in-human (FIH) programmes. Lonza’s SimpliFiH® Solutions
2 June 2020 | By Lonza
In this webinar, Lonza presents its approach to its FiH (first-in-human use) drug substance and technology-enabled drug product development programme, designed specifically to provide customers with a standardised and rapid, phase-appropriate early clinical supply programme (SimpliFiH®).
article
Why product information management is key to success in a changing pharma market
Mike Owen analyses how smart product information (PIM) management could be crucial in the future of pharma, given how large the industry continues to grow.
news
Lonza and Sanquin partner for commercialisation of specialised MAT reagents for accurate and reliable in vitro pyrogen testing
Lonza Sales AG, through its Bioscience Division has joined forces with Sanquin Reagents B.V. to enable drug developers and quality control laboratories to take full advantage of the power of the Monocyte Activation Test (MAT).
news
EMA commissions research in preparation for monitoring COVID-19 vaccines
The research will identify sources of data to monitor coverage and effectiveness, and support pharmacovigilance of COVID-19 vaccines once they are approved.
news
‘At home’ COVID-19 antibody tests: expert opinions and manufacturer warnings
Abbott has revealed its SARS-CoV-2 antibody test was not designed for at home use despite companies selling them for this purpose. Also, what do experts think about these tests?
news
Global COVID-19 hydroxychloroquine trial paused over safety concerns
The WHO has paused the hydroxychloroquine arm of a global trial while it investigates safety concerns highlighted by published studies.
article
Dealing with immunisation during the COVID-19 pandemic: India’s experience
Dr Saurabh Kumar Banerjee outlines the impact of COVID-19 on immunisation programmes in India and how organisations can hope to mitigate the consequences of missed vaccine doses.
news
Company develops a COVID-19 test for use on surfaces and wastewater
IberoGEN has developed a test to detect COVID-19 for use on surfaces and wastewater in the hopes of aiding in the return to normalcy.
whitepaper
Whitepaper: Rapid sterility testing: a new solution for short shelf life products
All drug products have to undergo sterility testing to comply with Good Manufacturing Practices (GMP). Rapid sterility testing, which offers an incubation period of five days or less, provides a solution.
video
On-demand webinar: Managing your pharmaceutical quality system with 50 percent fewer staff
In this webinar, Lynne Byers explains how you can continue to keep your manufacturing site operating compliantly with significantly less staff.
