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European decentralised CAR T manufacturing consortium launched
EASYGEN is supported by EU funding andindustry partners that include Fresenius, Charles River, Cellix, Pro-Liance and TQ Therapeutics.
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Technical University of Denmark
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Leveraging PAT for environmental monitoring in light of Annex 1
The pharma industry’s adaptation to Industry 4.0 has been slow, due to the extensive regulatory requirements imposed on manufacturers. However, regulatory agencies are starting to embrace movement towards more rapid/automated systems, as illustrated in the revised EU GMP Annex 1, which entered into force in August. Here, Isabella Jul-Jørgensen from the Technical…
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QA/QC & Environmental Monitoring In-Depth Focus 2023
In this in-depth focus, explore how automation is transforming environmental monitoring in line with Annex 1, implementation of contamination control strategies and discover the emerging trends and challenges in pharmaceutical microbiology.
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Patient-centred pharmaceutical packaging: are we there yet?
Despite tremendous innovation in the realm of pharmaceutical therapeutics, the packaging of medicines has been staid. In this article, Giana Carli Lorenzini from the Technical University of Denmark investigates the potential of patient-centred pharmaceutical packaging.
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TOC sampling error could be impacting cleaning verification
Study finds several variables can significantly increase the sampling error in total organic carbon (TOC) swab testing used for pharmaceutical cleaning verification.
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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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Online tool provides 3-D view of human metabolic processes
An international team of researchers has developed a computational resource that provides a 3D view of genes, proteins and metabolites involved in human metabolism...
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Pausing evolution makes bioproduction of chemicals affordable and efficient
Circumventing evolution in cell factories can pave the way for commercialising new biobased chemicals to large-scale.
