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20 October 2025 | By
The balance between speed, scale, and compliance has never been more critical. As GLP-1s, biosimilars, and advanced therapies reshape global priorities, pharma leaders face a new question: how can manufacturing infrastructure evolve fast enough to keep pace?
22 October 2013 | By Michael J. Miller, President, Microbiology Consultants, LLC and Suzan Mohammed Ragheb, Department of Biotechnology, The Nile Company for Pharmaceuticals and Chemical Industries
Rapid microbiological methods (RMM) have gained popularity and acceptance within a number of industry sectors, including food and beverages, diagnostics, environmental, personal care and pharmaceuticals. In recent years, many firms have successfully validated and implemented RMMs for a wide variety of applications. However, many geographic areas around the world still…
Read the free digital version of the August / September edition of European Pharmaceutical Review magazine...
IN this Informatics In-Depth Focus: Using LIMS for biobanking and implementing LIMS for research; Biologics development and ELN: A good match?; Informatics Roundtable...
In this RMMs & Environmental Monitoring In-Depth Focus: The rapid microbiological methods revolution; Controlling contamination in the pharmaceutical industry; Rapid Micro Methods Roundtable...
The International Conference on Harmonisation (ICH) guideline for the Validation of Analytical Procedures (ICHQ2(R1)) currently covers validation procedures for the four most common analytical tests: identification tests, quantitative tests for impurities, limit tests for the control of impurities and quantitative tests for the active moiety(ies) in APIs (active pharmaceutical ingredients)…
20 August 2013 | By Sheraz Gul, Vice President and Head of Biology, European ScreeningPort GmbH
Cysteine proteases are expressed ubiquitously in the animal and plant kingdom and are thought to play key roles in maintaining homeostasis. The aberrant function of cysteine proteases in humans are known to lead to a variety of epidermal disease states such as inflammatory skin disease1. In marked contrast, the serine…
20 August 2013 | By Richard Hayes, Continuous Improvement Manager, Rottapharm
From their headquarters based in Monza, Italy, Rottapharm’s long history of success began in 1961 with the creation of a small laboratory for independent research. The company from its early beginning has continuously invested in research, innovation and development of pharmaceutical products for distribution on a worldwide scale. After acquiring…
20 August 2013 | By Chanda R. Yonzon, Atul Karande, Sai P. Chamarthy and Brent A. Donovan (Merck & Co. Inc)
Raman spectroscopy has emerged as the preeminent analytical tool for a number of applications within drug discovery and development. Advances in the instrumentation, sensor fabrication and data analysis have enabled the wider acceptance of Raman spectroscopy1,2. In discovery, Raman spectroscopy is used to elucidate structural activity relationships3 and to optimise…
20 August 2013 | By Jonathan D. Lippiat, School of Biomedical Sciences, University of Leeds
Early in their undergraduate education, the student is introduced to various types of integral membrane protein: receptors, adhesion proteins, ion channels, ion pumps and ion transporters. As they progress through their studies, they find out that discrete gene families and protein structures are responsible for these different protein classes and…
20 August 2013 | By Niklas Larsson, Linda Sundström, Erik Ryberg and Lovisa Frostne (AstraZeneca)
G protein-coupled receptors are one of the major classes of therapeutic targets for a broad range of diseases. The most commonly used assays in GPCR drug discovery measure production of second messengers such as cAMP or IP3 that are the result of activation of individual signalling pathways. Such specific assays…
Read the free digital version of the June / July edition of European Pharmaceutical Review magazine...
In this Screening In-Depth Focus: New approaches to cell based assays for high content screening and analysis; Reduce, reuse, recycle: how drug repositioning is finding its niche in drug discovery; Workshop Review: Biochemical assays for screening. Screening roundtable...
In this Ingredients In-Depth Focus: Revisiting a mutual recognition agreement approach for GMP inspections to secure the safety of the supply chain of APIs; Solid form diversity of commonly used tableting excipients and its impact...
13 June 2013 | By Tony Moffat, UCL School of Pharmacy and Joint Pharmaceutical Analysis Group
The US Food and Drugs Administration (FDA) produced their guidance for industry on tablet scoring in March 2013 to ensure that tablet scoring (breakmarks or breaklines) on generic tablets would enable them to be split in the same effective way as their reference listed products (RLD).
13 June 2013 | By Michael J. Miller, President, Microbiology Consultants, LLC and rapidmicromethods.com
This is the second paper in our continuing series on Rapid Microbiological Methods (RMM) that will appear in European Pharmaceutical Review during 2013. As the editor for the Encyclopedia of Rapid Microbiological Methods, I provide a summary of the latest volume, which was published earlier this year. New case studies,…
