news
How should cleaning validation sampling locations be chosen?
Here EPR summarises the salient points of a case study, presenting a strategy for identifying worst-case sampling locations on equipment for cleaning validation.
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QA/QC
whitepaper
ebook: Guidance on implementation of ARMMs
Many quality control professionals recognise that the need to modernise microbial detection methods is at an all-time high.
video
On-demand webinar: Speed your biologic into phase 1-3 clinical trials
How shortening the timeline from development to clinic can be achieved through parallel processing versus using a task/time compression approach.
video
Webinar: Comparator sourcing success
Collaboration between comparator sourcing specialists and clinical supply managers can improve inventory management and supply chain performance.
video
Webinar: Responsibilities of specialised clinical supply experts
Learn the differences in areas of expertise and responsibilities between the Clinical Supply Manager, Project Manager and Financial Project Analyst.
article
Nitrosamine drug substance-related impurities (NDSRIs)
Dave Elder looks at the guidelines drug manufacturers should follow to reduce nitrosamine impurities, following several recent withdrawals.
article
Efficient shutdown recovery: leveraging RMM to unlock value and ensure environmental quality
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…
news
AEX-MS to become increasingly important in antibody characterisation
Study shows AEX-MS enables the analysis of IgG4 Fc deamidation variants and, as IgG4 antibodies become more popular, could become increasingly valuable for antibody charge heterogeneity characterisation.
news
Improved outcome for prostate cancer patients in Phase III PROpel trial
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.
article
Testing non-inferiority for accuracy of quantitative microbiological methods
Authors Edwin van den Heuvel, Maliheh Heidari, Kathrin Möllenhoff and Pieta IJzerman-Boon compare statistical analysis methods for determining comparable accuracy of alternate and compendial microbiological methods.
article
The importance of sterility testing in biopharmaceutical manufacturing
Robust sterility testing protocols are essential to protect patients, medicine supply chains and manufacturers’ bottom lines. But how do companies build successful sterility processes?
whitepaper
Whitepaper: Bridging the cell and gene therapy gap
The current understanding among sponsors of the workflow from cell collection, to manufacturing, and to the clinical site for patient administration.
article
QA/QC Microbiology/RMM In-Depth Focus 2022
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.
news
Machine learning model enables adventitious agent detection in cell cultures
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.
article
Future of pharmacovigilance: the six stages of automation
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.
