Revised ISO guideline highlights toxicological evaluation of extractables and...
In the guideline published in 2023, the process and requirements for toxicological risk assessment of medical device constituents is outlined. Also covered in the guideline are “the methods and...
View ArticleBiosensing technique promising for whole-genome detection
A study has described a multivalent-colloid detection system capable of identifying whole genomes of bacteria without the use of DNA amplification. Data from the paper published in Applied Physical...
View ArticleRaman and machine learning show promise for online monitoring of bioreactors
Researchers based in France have demonstrated a robust online Raman monitoring model for bioreactors, which combines Raman spectroscopy and machine learning (ML). In the study, the fermentation of...
View ArticleNelson Labs facility expansion to benefit parenteral and ophthalmic drug...
The investment… includes state-of-the-art instrumentation to provide full CMC support to serve the growth of PODP [manufacturers]” Nelson Labs, a global leader in microbiological and analytical...
View ArticleForward-thinking CDMO tackles the dynamic challenge of N-nitrosamines control...
Register your details to discover more about meeting global nitrosamine requirements, LC-MS/MS for identification and quantification of nitrosamines and how you can adapt to evolving trends. API...
View ArticleAnalytical technique may advance medical cannabis quality control
Researchers have proposed an advanced analytical technology that can rapidly classify medical cannabis plants at production sites. Using the analytical technique, the plants can be classified “by...
View ArticleValidation of analytical procedures – ICH Q2(R2)
After almost two decades, ICH Q21 (validation of analytical procedures) has finally been updated and now includes more recent analytical applications, which are non‑chromatographic in nature, eg,...
View ArticleCoherent Raman scattering microscopy: a powerful tool for pharmaceutics
Chemometric optical microscopy techniques provide numerous opportunities for the pharmaceutic industry, both in the manufacturing stage and in R&D for drug discovery and development. One valuable...
View ArticleUsing mass spectrometry to improve quality and safety of levothyroxine
In investigating formulations of the hypothyroidism drug levothyroxine, researchers have developed a new non-targeted approach using ultra-high-performance liquid chromatography with a data-independent...
View ArticleSafeguarding purity under pressure: detecting nitrosamine contamination
In 2018 the discovery of unacceptable levels of N-nitrosodimethylamine (NDMA) and N-nitrosodiethylamine (NDEA) in angiotensin receptor blockers (ARBs) triggered increased regulatory focus on...
View ArticleEuropean Pharmaceutical Review Issue 2 2024
Articles included in Issue 2 of European Pharmaceutical Review – our cell and gene therapy focus – include: CELL & GENE THERAPY Proper planning prevents CMC disasters for cell and gene therapies...
View ArticleGuide to Testing 2024
LoD requirements of qualitative microbiological methods for short shelf-life products In this article, Edwin van den Heuvel from Eindhoven University of Technology and MSD’s Pieta Boon investigate the...
View ArticleApplication of NGS to enhance the molecular monitoring of CML patients
ICON has developed a novel RNA-based Next Generation Sequencing (NGS) assay that supports more accurate monitoring of chronic myeloid leukemia patients. Here we discuss its benefits over standard NGS...
View ArticleAccelerating spectroscopic analysis for data acquisition
Researchers in Germany have developed an technique to increase the speed of spectroscopic analysis, which typically takes from minutes to hours to acquire measurement. [the technique] can greatly...
View ArticleAdvancements and knowledge gaps in ICH Q2(R2)
The landscape of scientific and technological advancements has evolved significantly since the finalisation of the first version of ICH Q2 in the 1990s. Particularly notable is the progress in advanced...
View ArticleSustainable RP-HPLC method for simultaneous determination of hypertension drugs
Researchers have demonstrated a reverse phase-high performance liquid chromatography (RP-HPLC) method for the simultaneous determination of Amlodipine and Irbesartan using analytical quality by design...
View ArticleTechnology innovation aiding process spectroscopy market growth
A report by Spherical Insights has predicted that the process spectroscopy market will value $35.8 billion by 2033. Process spectroscopy is becoming more connected to automation and digitalisation...
View ArticleAnalysis of chiral compounds using supercritical fluid chromatography
A study comparing sub/supercritical fluid chromatography (SFC) to normal phase high-performance liquid chromatography (NP HPLC) has reported that amylose tris (3‑chloro-5-methylphenylcarbamate)-based...
View ArticleSFC-MS: advancements and applications in pharmaceutical quality control
Pharmaceutical quality control (QC) is an essential aspect of the pharmaceutical industry, ensuring that medicinal products meet the desired quality standards and comply with regulatory requirements....
View ArticleOptimising reverse-phase chromatography for molnupiravir production
Research indicates that optimising column length and flowrate is essential for achieving desired separation efficiency and resolution when working to gain optimal chromatographic separation, research...
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