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The power of rapid methods for fungal ID

European Pharmaceutical Review

Fungal contamination in pharmaceutical products represents a potential hazard for two reasons. First, it may cause product spoilage; the metabolic versatility of fungi is such that any formulation ingredient may undergo chemical modification in the presence of a contaminating organism.

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What gene therapy manufacturers can gain from collaboration

European Pharmaceutical Review

Challenges in gene therapy manufacturing Photo: courtesy of PTC Therapeutics The biotech industry is facing a bottleneck in product manufacturing, with more than 1,000 gene therapies currently being developed as potential clinical candidates, 1 and not nearly enough capacity in manufacturing facilities to accommodate them.

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LAMP assays to enable rapid and sensitive detection of BCC

European Pharmaceutical Review

According to researchers, a ribB -based colorimetric loop-mediated isothermal amplification (LAMP) assay could become a fast and easy-to-perform detection method for testing non-sterile pharmaceuticals for BCC. Burkholderia species are one of the primary causes of non-sterile pharmaceutical product recalls and accounted for 45.3

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Preventing fungal contamination in pharmaceuticals

European Pharmaceutical Review

Additionally, this can be caused by “poor handling, repackaging, and nonadherence to good manufacturing practices [GMP] during dispensing and packaging have resulted in the microbiological contamination of non-sterile pharmaceutical products.” Ahmed et al.

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EMA publishes updated Q&A for ICH M10

European Pharmaceutical Review

The US Food and Drug Administration (FDA) implementation date was 7 November 2022. The post EMA publishes updated Q&A for ICH M10 appeared first on European Pharmaceutical Review. The draft ICH M10 guideline was published for comments in 2019.

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Forward-thinking CDMO tackles the dynamic challenge of N-nitrosamines control with high-performance analytical instrumentation

European Pharmaceutical Review

Its API manufacturing facilities undergo stringent inspections from regulatory authorities such as the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA).

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Nitrosamine Mitigation: A Path to Regulatory Compliance

PharmaTech

In the wake of the Food and Drug Administration's (FDA's) latest guidance on nitrosamine contamination, ensuring compliance and safeguarding pharmaceutical products is more critical than ever.