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World’s largest lutetium-177 production site opens
The new German facility has Industry 4.0 capabilities and will produce radionuclides to help meet the rising demand for radiopharmaceuticals.
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Manufacturing
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Scientific journal: Reduce CNS drug development timelines by up to 40%
CNS drug development is complex, and partnering with an integrated CRO/CDMO can reduce your timelines by up to 40%. Learn more in The Altascientist.
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Novo Nordisk invests €2.1bn in Hillerød manufacturing expansion
Danish pharmaceutical company Novo Nordisk plans to invest € 2.1bn to expand its production facility north of Copenhagen.
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FDA approves new cell therapy manufacturing plant
Bristol Myers Squibb has received approval from the US FDA to begin commercial production at its newest cell therapy manufacturing site.
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Pfizer and Samsung Biologics ink biosimilars manufacturing deal
Samsung Biologics has signed two long-term manufacturing agreements for Pfizer’s multiproduct biosimilar portfolio, worth $897 million.
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Radiopharma production facility opens in Belgium
Australian biotech Telix Pharmaceuticals has unveiled a new €14.1 million radiopharmaceutical production facility in Brussels South, Belgium.
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Video: High adhesion coating tablet with VIVACOAT® A
VIVACOAT® A shows outstanding adhesion to tablet cores achieved by using globally accepted excipients. Low adhesion can be the reason for the frequently observed effect of "logo bridging“.
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New quality requirements for tobacco products
Here, Dave Elder explores proposals for new FDA rules on tobacco product manufacturing. How could strategies for controlling tobacco-specific nitrosamines compare with those for nitrosamine drug substance-related impurities?
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How can biopharma strengthen its resilience?
A recent report has found that since 2021, biopharma resilience has decreased, affecting areas such as supply chain, strength of the R&D ecosystem and manufacturing agility.
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Cell and Gene Therapy Catapult opens new laboratories
Cell and Gene Therapy Catapult's new laboratories in Scotland aims to help cell therapy developers improve their manufacturing processes and navigate regulatory requirements.
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New AMR certification launched for antibiotic manufacturers
Following publication of the Antibiotic Manufacturing Standard in 2022 to help overcome AMR, antibiotic manufacturers can now verify their actions through a new certification.
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The cell and gene therapy CDMO bottleneck isn’t capacity – it’s capability
CDMOs have been squeezed by the sharp increase in companies preparing to scale their cell and gene therapy manufacturing for Phase III trials and commercialisation, and physical capacity has been a common scapegoat. But eXmoor CEO Angela Osborne says the real limiting factor is experience.
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Study identifies key contamination source during ATMP manufacture
Researchers say they are the first to demonstrate contamination of over 40 percent of lipoaspirate samples for adipose tissue-derived stem cell (ADSC)-based advanced therapy medicinal product (ATMP) manufacture.
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Analysis reports nitrosamine prevalence in small molecule drugs
Data from a paper on small molecule drugs has indicated nitrosamines in pharmaceuticals is likely more prevalent than originally expected.
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Novel PAT system could enable adaptive process control
A paper has demonstrated a novel refractometry-based process analytical technology (PAT) system has potential for enabling adaptive process control in CGT manufacturing.
