news
ICU Medical recalls one lot of Lactated Ringer’s Injection in US
The US FDA has announced ICU Medical is recalling a lot of Lactated Ringer's Injection due to iron oxide particulates being found by a consumer.
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QA/QC
video
On-demand webinar: ICH stability testing and method development
Stability testing is a vital part of product development and is conducted throughout a product’s life cycle.
whitepaper
Whitepaper: Establishing the proper PH range for aqueous simulating solvents used in extractables profiling
This whitepaper considers the chemical properties of commonly encountered acidic and basic extractables and uses these properties to address questions about establishing the proper pH (or proper pH range).
article
Sterile and antiviral packaging: unlocking the potential of business continuity and resilience during COVID-19 pandemic
Amid the disruptions due to COVID-19, companies providing sterile and antiviral packaging solutions look forward to opportunities arising from the concern over viral exposure itself. Regulatory compliance will play a significant role in the rapidly shifting risk terrain.
news
EMA recommends eight drugs for approval from April meeting
The EMA's human medicines committee has adopted a positive opinion for eight medicines, recommending their marketing authorisation.
news
New standards to help remove foreign particles in bioprocessing
ASTM International says its new standard for single use system manufacturing processes will help to prevent the contamination of biopharmaceuticals with foreign particles.
news
Utilising CRISPR could reduce contamination in recombinant-protein drugs
Researchers have used CRISPR-Cas to edit the genes of contaminating proteins in mammalian cells used to produce recombinant-protein drugs, which could reduce costs and strengthen quality.
news
Gilead announces primary endpoints met in Phase III remdesivir trial
Gilead has said that topline results for clinical recovery have been demonstrated in a Phase III trial of remdesivir, tested in COVID-19 patients.
article
Four MHRA ‘inspections and good practice’ guidances for the COVID-19 outbreak
Md Saddam Nawaz discusses four guidances released by the MHRA to help firms navigate the regulatory waters during the COVID-19 pandemic.
article
From commensalism to parasitism: the dangers of underestimating cleanroom bacterial contaminants
Marc Baiget Francesch explains how commensal bacteria can be opportunistic pathogens and why treating them as merely a light threat to cleanrooms can bring disastrous consequences.
article
How modern chromatography data systems are improving regulatory compliance in pharmaceutical manufacturing
Delivering confident QA and QC in pharmaceutical manufacturing is of critical importance. This article discusses how the latest chromatography data systems are ensuring compliance with modern regulatory requirements.
article
Native liquid chromatography coupled to mass spectrometric analysis for the assessment of higher order structures of proteins
The accurate measurement of the molecular mass of proteins is an essential component of protein characterisation. In this article, Ioannis Papayannopoulos discusses the applications of native protein chromatography coupled to mass spectrometry to enable the characterisation of tertiary structures and non-covalent interactions.
news
FDA sends two warnings to companies selling unapproved CBD products
Two companies selling unapproved cannabidiol (CBD) products including for the treatment of opioid addiction, have been handed warning letters from the FDA.
news
Supportive therapy better than novel treatments for COVID-19, say scientists
Instead of using new or repurposed treatment for COVID-19, doctors should focus on traditional critical care principles for patients, scientists have said.
article
Application of liquid chromatography in characterisation of lipid nanoparticle-based oligonucleotides
Duplex oligonucleotides (OGN) with lipid nanoparticles (LNPs) as delivery vehicles for different therapeutic indications are of great interest in pharma, exemplified by the recent approval of Onpattro from Alnylam Pharmaceuticals. Liquid chromatography is an essential analytical technique in the characterisation of LNPs containing OGNs. This brief review is intended to…
