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Appropriate standards for impurity tests are an important part of analytical testing. In this paper, Kevin Williams outlines various requirements of standards for endotoxin, as stated by United States Pharmacopeia (USP), and elaborates on the definition of endotoxin as distinct from other cellular constituents.
Nelson Labs has a long history of partnering with pharmaceutical and biopharmaceutical companies. We perform a variety of testing to support your internal quality processes including: sterility (USP 71) testing in a cleanroom for isolator environment, particulates testing (USP 787, 788) using a variety of methods, bacterial endotoxin, filter validations,…
There are many business challenges to developing a biologics drug, one of which is effective data management. In this article, Unjulie Bhanot focuses on efficient data management policies and systems, and how they could improve biologics product development processes.
Vaccinations have begun in a phase I human clinical trial testing a freeze-dried, temperature-stable formulation of an experimental tuberculosis vaccine candidate. Nikki Withers speaks to Dr Daniel Hoft and Christopher Fox about the formulation process and what this means for vaccine development going forward.
Biopharma developers and manufacturers need to know their molecules and understand their manufacturing processes better than ever before. In this article, Mike Wilson discusses the benefits of mass analysis in biopharma and the current challenges of adopting new technologies.
From starting materials through to finished product testing, Eurofins BioPharma Product Testing’s 34 facilities in 17 countries deliver a comprehensive scope of harmonised GMP testing services and seamless regulatory acceptance.
Those who work in QC know that the job is more than a box to be checked, and that it can’t be done effectively without confidence in the reported results. Tight timelines, regulatory demands, and stringent data integrity standards can make it hard to focus on what’s really at stake…
Wickham Laboratories Ltd, backed by five decades of global experience in GMP/GLP-regulated laboratory services, is an established name in the fields of pharmaceutical and medical device contract testing, research and consultancy.
The work of a pharmaceutical scientist requires precision, attention to detail and is of vital importance to the safety of products and ultimately patients. This section features insights from experienced scientists who’ve worked extensively in microbiological analysis, developing tests, methods and standards that help establish a foundation for the production…
Emerging recombinant Factor C (rFC) methods have many advantages to offer pharmaceutical quality control, including improved specificity, robustness, efficiency and alignment with 3R principles. First, global manufacturers have validated rFC and pharmacopoeias worldwide are on the move. Here, Karolina Heed provides an industry and regulatory update.
Modernisation of microbiological test methods involves far more than just the science. As new systems and technologies become available it becomes increasingly important that potential users can identify not only the technical requirements, but also the business case. Here, Paul Newby, Alice Laures and Lisa Wysocki from GlaxoSmithKline discuss criteria…
Today’s biopharmaceutical developers need accurate and precise information at all stages of research and development in order to bring safe and effective therapies to patients. This in-depth focus features novel perspectives from industry experts that serve to illustrate which technologies and systems are benefitting this cause.
In this edition of our ‘Guide to’ series, learn how these leading companies’ services and expertise can help you test your pharma/ biopharma products and medical devices.
As today’s scientists continue to identify new biopharmaceutical products with potential to treat a wide array of diseases, formulation remains the determining factor in their success. But what is involved in these increasingly complex formulation processes and how do they impact the packaging and delivery systems?
This issue questions whether companies are sufficiently investing in regulatory intelligence software and what the potential consequences of Brexit might be for locations outside of the UK and EU. The issue also features articles on microbiology, formulation and biopharma, courtesy of our in-depth focus sections; as well as outlining the…
