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FUJIFILM plans $1.2 billion investment in major US manufacturing facility
Proposed additions to the cell culture manufacturing facility are set to make the site one of the largest cell culture biopharmaceutical CDMO facilities in North America.
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Seasonal variation of microbial contamination in pharmaceutical cleanrooms
With the outdoor environment being a primary contamination source in the pharmaceutical cleanroom, measures like good manufacturing practices (GMP) is key to reduce this risk, a paper asserts.
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New partnership to aid supply of Ga-68-based radiopharmaceuticals
The new collaboration is set to ensure a steady, more accessible supply of Ga-68-based radiopharmaceuticals, thereby helping to address traditional logistical challenges due to gallium’s short half-life.
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Quality risk management in radiopharmaceutical production
A quality risk assessment of a Good Manufacturing Practice (GMP) radiopharmaceutical production site found that dispensing was the most critical phase of the process.
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Analytical technique may advance medical cannabis quality control
Combining near-infrared spectroscopy (NIR) hyperspectral imaging (HSI) and machine learning could offer a simpler, non-invasive alternative to established analytical techniques such as chromatography, research suggests.
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Live biotherapeutic products: bridging innovations and challenges in manufacturing
In our third instalment of EPR's exclusive ‘Microbiome therapeutics: microscope to medicine’ series, Tue Hodal, Chief Technology Officer and Lorenz Rindisbacher, Chief Quality Officer, Bacthera, explore how live biotherapeutic products (LBPs) represent a transformative shift in medicine, highlighting their unique challenges and potential.
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Preventing fungal contamination in pharmaceuticals
While fungal contamination detection in pharmaceutical manufacturing remains a challenge, preventive practices and policies must be followed, research states.
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The future of targeted alpha therapy development and manufacture
Following the first industrial-scale facility for targeted alpha therapy (TAT) production in Europe beginning construction, in this exclusive Q&A, Julien Dodet, CEO of Orano Med, elaborates on the key trends in radioligand therapeutics and why TATs hold significant advantages as cancer treatments.
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New radiopharmaceutical laboratory opens in Germany
Ariceum Therapeutics’ new Berlin-based laboratory gives the company internal capability to progress the development of its lead radiopharmaceutical candidates.
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UK manufacturing output expected to improve despite challenges
Output volumes for UK manufacturing fell in the three months to February 2024, yet it is expected to rise slightly in the next three months, research reports.
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WHO initiative to enhance biomanufacturing in LMICs
A new World Health Organization (WHO)-driven initiative aims to enhance bioproduction capabilities for biological products in low- and middle-income countries (LMICs).
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Overcoming challenges of continuous antibody manufacture
During monoclonal antibody (mAb) manufacture, continuous flowsheets could offer ~20 percent–40 percent cost of goods (COG) saving over the batch process, for instance, during low commercial demand, a paper suggests.
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Navigating the unique CMC challenges of oral anaerobic live biotherapeutics
Here, Chief Technical Officer, Mike Frodsham and Ryan Wilson, Head of Microbiome Services at SGS Quay Pharma, explore the chemistry, manufacturing, and control (CMC) challenges of developing drug products containing live anaerobic bacterial strains, used for treatments such as microbiome therapeutics.
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How will automation shape deviation management in continuous bioprocessing?
A paper has proposed how advanced manufacturing process technologies such as integrated continuous bioprocesses (ICB) could impact the future of deviation detection and control.
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Construction of major radioligand therapy manufacturing site begins
The new site will be Europe's first industrial-scale pharmaceutical facility dedicated to the production of lead-212 based radioligand therapies.
