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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.
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The quest for efficiency – moving towards continuous processing
There are many challenges faced by the biopharmaceutical industry in order to develop and provide sufficient drugs to treat a growing and ageing population. This article discusses whether continuous processing provides the solution.
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Latest innovations in child-resistant pharmaceutical packaging
The problem of children accessing medication at home is growing and the UK’s National Health Service (NHS) claims the most common form of poisoning1 in the UK is from medication, with children under five being most at risk. While parents have a role to play in the home by keeping…
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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.
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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.
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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.
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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.
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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…
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Nanoparticle delivery offers a possible alternative to opioid pain relief
An international team of researchers has used nanoparticles to deliver a drug – one that previously failed in clinical trials for pain – into specific compartments of nerve cells, dramatically increasing its ability to treat pain in mice and rats. Nikki Withers spoke to Nigel Bunnett to hear more about…
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British Plastics Federation releases guidelines on recycled packaging in pharma
A new document has been released by the British Plastics Federation to help the pharmaceutical industry and other sectors understand how recycled plastic can be used in packaging.
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Video: More efficient Cleaning Validation with Sievers TOC
TOC analysis in the lab, at-line, or online enables efficiency gains and process understanding for cleaning validation and monitoring programs.
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Fresenius Kabi recalls 13 lots of ketorolac tromethamine injection
The FDA has announced that Fresenius Kabi is voluntarily recalling 13 lots of ketorolac tromethamine injection due to particulate matter found in reserve sample vials.
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Research focus should remain on high quality studies during COVID-19 pandemic, say scientists
Exceptions to high quality research should not be made simply because of the COVID-19 pandemic, argue scientists in a new commentary.
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Manufacturing, Packaging & Logistics In-Depth Focus 2020
Included in this in-depth focus are articles examining the importance of child-resistant medicinal packaging and analysing whether continuous processing is the future for pharma.
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Avet recalls tetracycline HCl capsules to consumer level
The company announced the voluntary recall is due to low, out of specification dissolution test results in specific batches of its tetracycline products.
