What can we learn from contamination control failures?
Here EPR summarises the key points of Jeanne Moldenhauer’s article on what can be learned from warning letters and regulatory inspection observation reports.
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Here EPR summarises the key points of Jeanne Moldenhauer’s article on what can be learned from warning letters and regulatory inspection observation reports.
Study reveals that different Bacillus strains sporulate better in different media and conditions, establishing optimal parameters to produce spores for disinfectant efficacy studies.
Here, EPR summarises Tim Sandle's review of different methods for transferring items into aseptic areas, including decontamination chambers and pass-through hatches.
Here EPR summarises the salient points of a case study, presenting a strategy for identifying worst-case sampling locations on equipment for cleaning validation.
Many quality control professionals recognise that the need to modernise microbial detection methods is at an all-time high.
How shortening the timeline from development to clinic can be achieved through parallel processing versus using a task/time compression approach.
Collaboration between comparator sourcing specialists and clinical supply managers can improve inventory management and supply chain performance.
Learn the differences in areas of expertise and responsibilities between the Clinical Supply Manager, Project Manager and Financial Project Analyst.
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…
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.
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.
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.
Robust sterility testing protocols are essential to protect patients, medicine supply chains and manufacturers’ bottom lines. But how do companies build successful sterility processes?
The current understanding among sponsors of the workflow from cell collection, to manufacturing, and to the clinical site for patient administration.