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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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Drug Manufacturing
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Pistoia Alliance launches Pharma Innovation Council
The Pharma Innovation Council will work to overcome industry barriers such as R&D challenges and the adoption of emerging technologies.
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Moderna chooses mRNA vaccine manufacturing centre location
Following finalisation a ten-year strategic partnership with the UK government, Moderna has chosen the location for its Innovation and Technology Centre (MITC).
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New purification method could enhance protein drug manufacturing
Bioconjugate-functionalised nanoparticles can isolate proteins from a bioreactor fast and inexpensively, MIT researchers have found.
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UK partnership set to revolutionise oligonucleotide manufacture
CPI, AstraZeneca, Novartis, and The University of Manchester will collaborate to facilitate large-scale manufacture of oligonucleotides.
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New workflow for the analysis of mRNA therapeutics
Here, Mark Dickman, Professor in Bioanalytical Science and Engineering at the University of Sheffield, explores how analytical techniques such as liquid chromatography-mass spectrometry can support the manufacturing of mRNA therapeutics.
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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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Collaboration to support quality production of biologics
US Pharmacopeia (USP) and American Type Culture Collection (ATCC) will collaborate to better support the biologics sector in R&D, process development and release of high-quality biologics.
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UPC opt-out – a strategic balancing act for pharma
The European patent landscape is expected to change in 2023 with the launch of the Unified Patent Court. Owners of classic European patents can decide now if their patent will be litigated in the UPC or withdraw from it. Here, Jules Fabre and Sarah Taylor, lawyers at Pinsent Masons, detail some…
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Challenges in pharmaceutical microbiology: looking to the future
Here, Edward C Tidswell, Executive Director Quality Assurance at Merck & Co, Inc., discusses the microbiology challenges for industry, pharmaceutical companies and microbiologists themselves.
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Shining a light on Raman for microbiological analysis
The detection and identification of bacteria is essential for biopharmaceutical production, the assessment of new antimicrobials and assessing contamination control measures. Developing methods for complex environments is challenging due to interference from the various molecules present. Here, pharmaceutical microbiologist and contamination control expert Dr Tim Sandle explains how Raman spectroscopy…
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Developing terminal sterilisation processes for oligonucleotide drugs
A report reviewing the state of sterile oligonucleotide drug processing has recommended ways to aid development of terminal sterilisation processes.
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PDA releases contamination control strategy report
Technical Report 90: Contamination Control Strategy Development has been released by the Parenteral Drug Association (PDA).
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Identifying bacterial isolates to help prevent cleanroom contamination
A paper aiming to identify bacterial isolates on cleanroom operators’ garments, showed these surfaces were a major source of contamination.
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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.
