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Over the last century, the bacterial endotoxin test (BET) has evolved to keep pace with modern technology and lab expectations: from rabbit pyrogen testing to Limulus amebocyte lysate (LAL), to current developments with recombinant horseshoe crab coagulation factors.
Nelson Laboratories, with their unique database of over 6,000 compounds for detection, discuss the testing requirements for extractables and leachables and why identification and quantification in extraction studies will become increasingly crucial for pharmaceutical and medical device product safety and integrity.
Pharmaceutical and medical device manufacturers can now use the compendial chapter 2.6.32.
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.
Junior Editors of European Pharmaceutical Review, Hannah Balfour and Victoria Rees, discuss some of the most noteworthy news and announcements from this year.
Read this in-depth focus to develop your expertise in the characterisation of pharmaceutical powder and fluid flows during continuous manufacturing and find out the benefits of adopting high-resolution, cryogenically cooled thermal imaging for bottle packaging testing.
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…
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.
Pfizer spokesperson reveals supply chain challenges and late clinical trial results contributed to its COVID-19 vaccine production target for 2020 being halved.
An independent review has outlined the achievements of the UK's Vaccine Taskforce, finding it worked "at great pace" to bring a COVID-19 vaccine to patients.
In this article, Dr Jaime Shamonki, Generate Life Science’s CMO, discusses how newborn stem cells derived from umbilical cord tissue could make mesenchymal stem cells less expensive and variable to produce.
