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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.
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Impurities
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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).
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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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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.
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Supporting internal quality processes
At Nelson Labs, we have a long history of partnering with pharmaceutical and biopharmaceutical companies.
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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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Amneal recalls three nizatidine lots due to potential NDMA contamination
The FDA has said that Amneal Pharmaceuticals is recalling three lots of nizatidine oral solution at the consumer level due to potential NDMA contamination.
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FDA warns company selling fraudulent COVID-19 products containing chlorine dioxide
The US Food and Drug Administration (FDA) issued the letter after finding the products contain chlorine dioxide, a powerful bleaching agent with potentially fatal side effects.
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How is liquid chromatography used in the pharmaceutical industry?
Liquid chromatography is an analytical technique utilised widely in the pharmaceutical industry. How does it work and what other methods can it be combined with to enhance its uses?
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FDA requests recall of all ranitidine products on US market
The US FDA has announced that all manufacturers should withdraw their ranitidine products from the market due to the risks associated with NDMA impurities.
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Hikma Pharmaceuticals extends Ketorolac Tromethamine recall in US
The FDA has announced that Hikma are now recalling certain lots of Ketorolac Tromethamine injections at the medical facility and retail levels.
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Online pharmacy finds high levels of NDMA in metformin
Tests conducted by an online pharmacy has revealed high levels of NMDA in the diabetes drug metformin, prompting the company to press for a recall.
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EMA announces update on nitrosamine impurities in medicines
The EMA has released an update on nitrosamines in drugs, saying that work is continuing to prevent and manage these impurities.
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American Health Packaging voluntarily recalls ranitidine tablets
Ranitidine tablets have been recalled due to the possibility of the products containing unacceptable levels of NDMA.
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Regulating heavy metals in cannabis: what can be learned from the pharmaceutical industry?
The ever-increasing demand for cannabis-based products requires US state regulators to set guidelines that ensure products are safe for human use. However, as medicinal cannabis moves forward at a rapidly increasing pace, regulations are falling behind. Here, Robert Thomas discusses the many inconsistencies across US states for monitoring levels of…
