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FDA publishes recommendations on psychedelic clinical trial design
New draft guidance published by the US Food and Drug Administration (FDA) is intended to aid clinical study design in psychedelic drug development programmes.
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Active Pharmaceutical Ingredient (API)
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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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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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Automation to guide technology shift in aseptic environments
Referencing Annex 1–2022, a paper has described how automation will be implemented in aseptic environments in view of regulatory requirements.
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European Pharmaceutical Review Issue 2 2023
EPR Issue 2 includes articles on the future of cell and gene therapy, the potential of AAV gene therapies, NMR relaxometry and more…
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Could ATR-FT-IR spectroscopy become ‘gold standard’ for heparin analysis?
A paper states ATR-FT-IR spectroscopy plus multivariate analysis for heparin analysis is cost-effective compared to NMR.
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Eli Lilly promises additional $1.6b manufacturing investment
A total $3.7 billion investment at LEAP Innovation Park in the US is Eli Lilly and Company’s largest manufacturing investment at a single location in its history.
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Navigating delivery challenges of nucleic acid therapeutics
A paper has reviewed how novel drug delivery systems could achieve stable formulations of nucleic acid therapeutics.
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Collaboration to produce 3D screen printed pharmaceuticals
A new collaboration between two industry players for cGMP production of 3D screen printing technologies could reduce drug development costs.
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Handling HPAPIs safely – what does it take?
Here, Veranova's Global Head of Analytical Research & Development, Dr Kishore Hotha, outlines safety considerations when manufacturing and handling highly potent APIs (HPAPIs).
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Enhancing bioavailability formulations containing soluble acidic drugs
Research has revealed efficiency of a multi-compartmental dissolution method used to predict in vivo performance of BCS Class IIa compounds.
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Bioavailability enhancement services market to exhibit 11 percent CAGR
Between 2022 and 2035, the bioavailability enhancement services market will see an 11 percent compound annual growth rate, a report has predicted.
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Application note: Rapid identification of Polysorbates 20 and 80 through amber bottles
How the Vaya handheld Raman spectrometer differentiates and identifies PS 20 and PS 80 with spatially offset Raman spectroscopy (SORS) technology.
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Medicinal cannabis: the route to good manufacturing practice registration
Following on from the first GMP registration of a cannabis API for a UK pharmaceutical facility, EPR spoke with Celadon Pharmaceuticals about how it navigated the complex regulatory landscape.
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Lonza completes bioconjugation facility expansion
The planned expansion of Lonza’s bioconjugation facility in Visp, Switzerland has been completed, the company has announced.
