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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Raman spectroscopy – a promising alternative approach for sterility testing
Study combining Raman spectroscopy with PLS-DA multivariate analysis achieves fast and non-invasive detection of contaminated drug products within vials.
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).
Bavarian Nordic to supply EU Member States with monkeypox vaccine
Bavarian Nordic has announced it will supply 110,000 doses of its MVA-BN smallpox/monkeypox vaccine to the European Health Emergency Preparedness and Response Authority (HERA) over the coming months.
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.
New guidance for membrane-based water for injection systems
The new Guide from ISPE presents best practices for design, operation, maintenance and quality of membrane-based water for injection (WFI) systems.
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.
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.
New Berlin site to accelerate cell therapy innovation for BlueRock Therapeutics
BlueRock Therapeutics LP has established a new site for cell therapy innovation on Bayer’s campus in Berlin, Germany.
Fund to fast-track innovative drugs to NHS
The UK Government has announced the launch of the Innovative Medicines Fund to bring cutting-edge treatment more quickly to NHS patients.
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.
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.
EMA’s first critical medicines list for COVID-19
The approved COVID-19 vaccines and treatments on the list will be monitored to prevent and mitigate the impact of shortages.
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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Lonza’s latest: More sensitive non-endotoxin pyrogen detection now possible with Lonza’s new PyroCell® Monocyte Activation Test – Human Serum System
The PyroCell® Monocyte Activation Test - Human Serum System (PyroCell® MAT HS System) provides more sensitive detection of non-endotoxin pyrogen contaminants in pharmaceutical preparations.
