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Over the last 10 years, there has been an important change of focus in pharma towards biotech products and personalised therapies. These important new treatments are now emerging into manufacturing, with implications for the way that quality is monitored, managed and assured. Dr Eduard Cayón sets out some practical advice.
The International Society of Pharmaceutical Engineering’s GAMP® 5 guidelines steer validation practices for pharma companies to meet computerized system expectations. Members of the GAMP steering committees, Lorrie Schuessler, Charlie Wakeham and Stephen Ferrell, share the some of the key changes in the second edition update and how these should be…
EPR rounds up results from several key clinical trials on therapies for hypertension and heart failure presented at the American Heart Association’s Scientific Sessions 2022.
The biological characterisation of complex medicines like nucleic acid therapeutics and antibody-drug conjugates is important to understand their biodistribution and cellular delivery. Here, Isabel Peset, Lorna FitzPatrick and Martin Main from Medicines Discovery Catapult discuss the potential for using advanced light microscopy techniques.
Facing limited viral vector manufacturing capacity, should companies consider further integrating their viral vector supply to address this issue? James Nanista and Josh Hunt of Adaptimmune reflect on the options.
Keith A Zullow and Jenny J Zhang from Goodwin Procter examine upcoming US pharmaceutical regulation and how, if passed, it could impact European pharma/biopharma looking to access the US market.
4 November 2022 | By
Could the new wave of taxane chemotherapies succeed where traditional chemotherapies have failed? Colin Freund, Chief Executive Officer of Modra Pharmaceuticals, reveals the benefits of this emerging generation of anticancer treatment.
First-in-human clinical verification is one of the first critical milestones in drug development. Abhijeet Sinha, Senior Scientist at Lonza Small Molecules, exemplifies the imperative of solving drug development challenges in the early phases.
27 October 2022 | By
Articles in this drug formulation In-Depth Focus explore the design of formulations using cyclodextrins, plus the development of orally-delivered taxane chemotherapies.
In this Guide to Outsourcing & Testing, EPR explores trends in the pharmaceutical outsourcing market. Plus, Charles River discusses solutions for tracking, trending and microbial identification and Associates of Cape Cod International showcases its endotoxin testing capabilities.
Size exclusion chromatography (SEC) is routinely used in the pharmaceutical industry to characterise the higher and lower molecular weight species proteins. Here, Gregory Webster, Senior Principal Research Scientist in Analytical Research and Development at AbbVie, explores the challenges, opportunities and optimisations needed to execute design of experiment studies to project…
Having recently conducted a project to implement more sustainable, reliable and efficient bacterial endotoxin testing across the global Roche corporation, those involved in the project discuss with EPR’s Hannah Balfour the key takeaways from their implementation and validation, as well as current trends in bacterial endotoxin testing.
Are you leveraging all the information from your QC data? A secure, compliant and powerful data management tool is critical for maintaining a state of control.
Identification of environmental isolates is a regular requirement in pharmaceutical manufacturing, and strain differentiation can be valuable in a variety of circumstances. There have been huge advances in the technology available for sequencing bacterial genomes, which has fed through to the analyses that are available to pharmaceutical microbiologists. NCIMB’s Identification…
Cyclodextrins are a frequently used excipient in the pharmaceutical industry, employed in multiple dosage forms and with multiple purposes simply because of their numerous positive properties, including being generally well tolerated and safe. In this short article, René Holm, Professor in pharmaceutical physical chemistry at the University of Southern Denmark,…
