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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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Manufacturing
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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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Novel nanofiltration method for microbial biosurfactant downstream processing
A paper has reported an innovative downstream method using nanofiltration for microbial biosurfactant production offers superior purity.
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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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Biopharma struggling to find talent with adequate digital skills
While there has been "strong progress" in addressing certain skills gaps, advancing tech like AI means biopharma are increasingly seeking talent with data skills, ABPI stated.
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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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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.
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New UK drug delivery centre to support RNA therapeutic development
To develop new lipid nanoparticle formulations for RNA therapeutic delivery technologies, CPI and partners are working to establish a new UK Intracellular Drug Delivery Centre.
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Big Pharma inventory management trends revealed
Rapid growth of Big Pharma manufacturer inventories fail to prevent medicine shortages, a 2022 report has highlighted.
