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Here, Sridhar Pennathur, Vice President, Analytical Development at Novavax, highlights the value of next generation sequencing in their vaccine production operations by answering key questions.
Handling highly potent active pharmaceutical ingredients (HPAPIs) or drug product in a laboratory requires implementation of strict security measures. Here, Elodie Barrau and Olivia Jones discuss high potency product handling procedures to ensure continued safety.
With demand for biopharmaceuticals rising and advances being made in bioseparation systems, the global market it expected to witness significant growth.
Targeted protein degradation (TPD) therapy has grown rapidly as a field, with transformational potential. TPD is poised to be successful in delivering marketed products, but limitations are now starting to emerge, including tumour resistance, a lack of mechanisms for oral dosing, and the inability to penetrate tissues such as the…
Dave Elder looks at the guidelines drug manufacturers should follow to reduce nitrosamine impurities, following several recent withdrawals.
New technologies are awaiting implementation by the pharmaceutical industry to improve and optimise processes, but as they are not compendial and may require lengthy approval processes, their adoption as a replacement for a compendial method is slow, if at all possible. Though the industry is still contemplating how to unlock…
Lynparza (Olaparib) in combination with abiraterone plus prednisone reduced the risk of disease progression or death by 34 percent in the Phase III PROpel trial for prostate cancer patients.
The Phase III trials saw 75 percent of women in the relugolix combination therapy group achieve a reduction in dysmenorrhea (menstrual pain), compared with 30 percent or less of women in the placebo groups.
Robust sterility testing protocols are essential to protect patients, medicine supply chains and manufacturers’ bottom lines. But how do companies build successful sterility processes?
After previous reports that nearly all spinal muscular atrophy (SMA) patients treated with Zolgensma® achieved key motor milestones, Novartis announces publication of full SPR1NT results.
Articles in this in-depth focus discuss how you can compare the accuracy of alternate and compendial micro methods and explore the use of RMM to enhance microbial control alongside compendial methods.
Researchers have developed a rapid, label-free process analytical technology, called the anomaly detection model, to monitor microbial contamination in cell cultures in near-real-time.
Here, Andrew Mitchell of IQVIA outlines the six stages of pharmacovigilance case automation, exploring how implementing intelligent automation such as AI and ML could benefit pharmaceutical companies.
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.
Study combining Raman spectroscopy with PLS-DA multivariate analysis achieves fast and non-invasive detection of contaminated drug products within vials.
