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Advancing nitrosamines analysis with gas chromatography
Researchers suggest full evaporation static headspace gas chromatography (FE-SHSGC) could be a universal method for the analysis of semi-volatile nitrosamines in pharmaceutical products.
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Drug Manufacturing
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Standard for antibiotic manufacturing to help combat AMR
The standard requires antibiotics manufacturers to have effective environmental management systems in order to minimise pharma’s role in spread of environmental antimicrobial resistance (AMR).
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EMA’s PRAC June meeting highlights
EMA's Pharmacovigilance Risk Assessment Committee (PRAC) finds the benefits of amfepramone medicines do not outweigh their risks and addressed possible links between COVID-19 vaccines and menstruation.
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Onshoring and global health – has the pandemic sent globalisation into reverse?
The pandemic has been a game-changer for the pharmaceutical industry, sending the seemingly inexorable globalisation trends into reverse, with Big Pharma increasingly seeking more domestic supply chain options. Here, Karen Winterhalter of Onyx Health shares her expert insights on the impact of this emerging trend on the industry.
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Digital growth focus of Sanofi’s new Digital Accelerator
Sanofi announces first Digital Accelerator to develop products and solutions that foster the use of digital, data and artificial intelligence.
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Detecting and eradicating mycoplasmas in ATMP cell lines
Here, EPR summarises the key points of Tim Sandle’s recent review of mycoplasma risks, detection and eradication techniques for cell cultures.
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HPLC market to grow by $1.26bn in five years
Increasing uses of high-performance liquid chromatography (HPLC) and rising healthcare investment driving market growth, finds report.
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Lonza and Kodiak open custom-built bioconjugation facility
The newly opened facility will support the rapid launch and commercial manufacturing of KSI-301, Kodiak’s investigational retinal disease therapeutic.
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Inflation/cost of goods major concerns for pharma manufacturing
Pharma industry calls for support as restrictive pricing measures and rising costs of goods/inflation could undermine the availability of medicines.
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Ensuring content uniformity for HPAPI products
Here, EPR discusses critical considerations to ensure content uniformity in HPAPI drugs produced using dry techniques.
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HPAPI market to value $27bn by 2025
Driven by oncology drug demand, the highly potent active pharmaceutical ingredients (HPAPIs) market is anticipated to grow by $7bn in three years.
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Could process data offer a different approach for predicting quality?
A data collection study provides a product quality dataset that could form the basis of advanced analytical models to predict final product quality.
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Update on setting occupational exposure limits
Here, EPR summarises a recent review, outlining the critical considerations when setting occupational exposure limits (OELs), with a focus on HPAPIs.
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Altruistic initiatives aim to improve patient care in developing regions
Ambitions to reach greater numbers of patients with unmet need have fuelled some benevolent plans from bio/pharmaceutical companies ViiV Healthcare and Sandoz.
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Raman enables 3D visualisation of tablet structure
Research reveals how combining sample sectioning with Raman imaging enables the three-dimensional (3D) imaging of an oral solid dosage form matrix.
