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This article shares the results from an evaluation of a novel thermal imaging technology that took place before the initial implementation in a Pfizer manufacturing facility. The manuscript describes the technology and reviews the extensive process used to challenge its inspection capabilities through field testing. Finally, the potential benefits of…
Since their debut, the range of applications for which deep ultra-violet (DUV) handheld devices are used in the pharmaceutical setting continues to grow. For pharmaceutical or biopharmaceutical cleaning verification, there is a requirement for a versatile and adaptive analytical and imaging device to demonstrate and document cleaning cycles. Here, Krishnakumar…
Cleaning validation is an important element to current good manufacturing practice (cGMP) manufacturing to ensure purity, quality and potency of drug product. Above all, patient safety is the primary concern.
Dave Elder discusses whether the goals of QbD have truly been met and questions whether the complex processes, lack of clarity and high costs have resulted in the promised global harmonisation.
In this in-depth focus find out why deep ultra-violet (DUV) handheld devices could replace current onsite cleaning verification applications and how Raman spectroscopy could be used to improve COVID-19 detection.
The EMA's human medicines committee has released its results for the December meeting, suggesting which therapies should receive marketing authorisation.
Industry experts share their latest research and developments in pharma.
This issue focuses on whether our vaccine innovation capabilities will prepare us for future outbreaks, how Raman spectroscopy can be used to rapidly detect SARS-CoV-2 and the development of high-throughput glycoanalytics for biopharmaceuticals. Also included are articles on opportunities in the global API market and how to successfully identify defects…
Following reports of the Pfizer/BioNTech COVID-19 vaccine causing anaphylaxis, the MHRA has said those prone to allergic reaction should not receive the jab.
A combined testing procedure to overcome the manufacturing bottleneck caused by the time needed for compendial bioburden testing according to EP.
Akshita Pacholi outlines why the filtration market is so important to the pharmaceutical industry and discusses its predicted growth in the near future.
Upholding biosafety standards in coronavirus vaccine development and manufacturing despite the acute worldwide need.
Validation of syringe filters for QC testing: The parameters that influence analyte binding to filters.
The new general chapter (2.5.42) outlines three procedures for the analysis of N-nitrosamine impurities in active substances.
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The UK’s Vaccines Manufacturing and Innovation Centre (VMIC) has selected Lonza’s MODA-EM™ Solution to digitise its Microbiology Quality Control operations. The MODA EM™ Platform will form a vital part of ongoing work that will support the VMIC coming online a year ahead of schedule.
