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Eurofins BioPharma Product Testing

10 May 2019 | By

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.

Charles River microbial solutions

8 May 2019 | By

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…

Microbiology In-Depth Focus 2019

7 May 2019 | By

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…

Expert View: Advancing bacterial endotoxin testing with recombinant Factor C

7 May 2019 | By

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.

Biopharma Processing & Development In-Depth Focus 2019

26 April 2019 | By

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.

Guide To Testing

26 April 2019 | By

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.

Formulation In-Depth Focus 2019

26 April 2019 | By

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?

European Pharmaceutical Review Issue 2 2019

25 April 2019 | By

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…

Paving the way to a bright future for single-use bioprocessing

18 March 2019 | By

Pharmaceutical and biotech companies together offer life-changing or, more appropriately, life-saving medicines and materials containing medicines for patients across the world. To ensure demand is met and patients’ health is not compromised, it is essential a strong and secure supply chain is in place to support the drug development lifecycle.…

Compulsory licenses in Germany: a tool for licensing negotiations?

8 March 2019 | By

The Merck v. Shionogi case of 2017 laid the groundwork for further establishing compulsory licensing as a strategic tool in Germany, particularly in pharma patent litigation. A recent decision in a proceeding brought by Sanofi now provides more guidance on the threshold for obtaining such a compulsory license. This article…