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Transforming pharmaceutical manufacturing: The AI revolution

European Pharmaceutical Review

Revolutionising quality control In the backdrop of stringent quality standards and regulatory demands inherent to pharmaceutical manufacturing, the addition of AI technologies introduce a paradigm shift. Integrative Analysis of Multi-Omics Data with Deep Learning: Challenges and Opportunities in Bioinformatics.

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Chromatography analysis for nitrosamine quantitation in pharmaceutical manufacturing water

European Pharmaceutical Review

In conclusion, because there is “so little nitrite in purified water” using it in drug substance manufacturing processes, “even under acidic conditions and in the presence of vulnerable amines, does not constitute a nitrosamine presence risk for the product in most cases”. The paper was published in Organic Process Research & Development.

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How New Regulations Are Impacting Pharmaceutical Manufacturing Facility Design

PharmaTech

New regulations, including those put forth by Annex 1, require many pharmaceutical manufacturers to rethink their facility designs to promote compliance.

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European PFAS restriction could jeopardise pharmaceutical manufacturing

European Pharmaceutical Review

According to the European Federation of Pharmaceutical Industries and Associations (EFPIA), more than 600 essential medicines are at risk if a proposed restriction on the use of fluorinated substances, per- and polyfluoroalkyl substances (PFAS) across pharmaceutical manufacturing in the EEA, is implemented.

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India’s lax oversight of pharmaceutical manufacturing imperils health around the world

STAT

Cough medicine tainted with ethylene glycol that killed at least 19 children in Uzbekistan in late December 2022 has once again revealed lax oversight and regulation of pharmaceutical companies based in India. That preventable tragedy, which involves products made by Marion Biotech, based in Noida, India, echoes earlier cases.

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Elevating pharmaceutical manufacturing processes with real-time insights

European Pharmaceutical Review

This can lead to refined (bio)pharmaceutical manufacturing operations that propel product quality, operational efficiency and overall productivity to new heights. The post Elevating pharmaceutical manufacturing processes with real-time insights appeared first on European Pharmaceutical Review.

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Sustainability in pharmaceutical manufacturing: a CDMO’s contribution

BioPharma Dive

Consideration of sustainability early in process development, throughout the entire development cycle, and across the entire supply chain must also become common practice.