The agency has assigned new EU member state rapporteurs and co-rapporteurs to medicines previously assigned to the UK's Medicines and Healthcare products Regulatory Agency. / read more /
A new book published in response to new USP chapters and ICH Q3D guidelines on measuring elemental impurities provides a practical guide for using plasma spectrochemistry for pharmaceutical analysis. / read more /
FDA sent a warning letter to Tris Pharma Inc. after investigators found the company had failed to properly investigate batch failures and establish quality control procedures. / read more /
The biopharmaceutical firm has chosen Rhode Island as the site of its next-generation biomanufacturing plant, which will offer flexibility, speed, and efficiency. / read more /
The new 300,000-square-foot facility is considered the largest dedicated cell and gene therapy manufacturing facility with fully integrated services. / read more /
In this three-part podcast series, Rob Thomas, principal consultant at Scientific Solutions, discusses the impetus behind his new book, Measuring Elemental Impurities in Pharmaceuticals: A Practical Guide, published on Feb. 2, 2018. / read more /
Research suggests that radiation can have a significant impact on the composition and rheology of hydroxyethyl cellulose-based medicinal gels. / read more /
Comprehensive GMP Laboratory Testing Services
From Starting Materials through Finished Product Testing, Eurofins BioPharma Product Testing’s 28 facilities in 16 countries deliver the most comprehensive scope of harmonized GMP testing services and seamless regulatory acceptance.
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Changes Everything – LCMS-8060 triple quadrupole mass spectrometer expands UFMS family
Shimadzu’s LCMS-8060 is designed to push the limits of LC/MS/MS quantitation for applications requiring the highest sensitivity and robustness while delivering a meaningful solution for routine LC/MS/MS analyses. / Read more/
SMA MicroParticle ICSTM
VAI is pleased to announce the addition of the SMA MicroParticle ICS line of non-viable particle counters that utilize the latest innovation in particle counting technology, to our contamination control portfolio. / Read more/
Vaccines—from childhood and influenza immunizations, to epidemic prevention, to cancer and therapeutic treatments—present unique development challenges. In this Vaccine and Manufacturing eBook, the editors explore development and manufacturing options to make vaccines more accessible.
