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Features in this in-depth focus review the advances in bacterial genome sequencing and its role in pharmaceutical microbiology, as well as key considerations for when implementing and validating recombinant Factor C (rFC) endotoxin testing. Plus, coverage of how proposed US pharmaceutical regulation could impact European companies, in-house lentiviral vector manufacturing…
Innovation forms the basis of every emerging technology. That is certainly the case with cell and gene therapies (CGTs), and the search for efficient quality control (QC) test methods continues to grow in this pharmaceutical sector. One of the most important factors to consider while deciding on a QC method…
Given industry's recent focus on the sustainability of bacterial endotoxin testing (BET), here, AstraZeneca colleagues Miriam Guest, Karen Capper, Dennis Wong and Phil Duncanson share how they worked to establish a short-, mid- and long-term strategy to optimise BET across the global enterprise. They also explore some of the short-term…
Features in this in-depth focus explore the development of a sustainable approach to bacterial endotoxin testing (BET) within a global enterprise, as well as progress towards the use of biofluorescent particle counters for water bioburden applications.
In EPR Issue 4, experts discuss implementing a global strategy to improve the sustainability of endotoxin testing, how to accelerate timelines for manufacture of multi-specific antibodies and the potential of oncolytic viruses as a therapy for glioblastoma. Also featured: progress towards smart vaccine manufacturing, an update on edible anticounterfeiting technology,…
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The PyroCell® Monocyte Activation Test - Human Serum System (PyroCell® MAT HS System) provides more sensitive detection of non-endotoxin pyrogen contaminants in pharmaceutical preparations.
Find out how SGS’s high-quality analytical testing solutions could benefit all phases of your drug development programmes, from discovery through commercialisation.
Welcome to European Pharmaceutical Review’s Guide to Testing. In this edition, Oliver Großgart, Plant Safety Expert at TÜV SÜD Industrie Service GmbH, discusses the benefits of leveraging acoustic emission testing to identify faults in compressed air pressure vessels, and Associates of Cape Cod and SGS Health Science showcase their services,…
Download this whitepaper to discover the latest developments and research in QA/QC for biologic therapies via exclusive articles, interviews and application notes.
Join Rey Mali and Félix Montero-Julian as they discuss the challenges facing the manufacture and QC of advanced therapy medicinal products (ATMPs) and potential solutions.
The future of sustainable LAL testing has arrived with ACC’s PyroSmart NextGen recombinant LAL reagent technology for bacterial endotoxin testing (BET).
Welcome to European Pharmaceutical Review’s Guide to Outsourcing. In this edition, Gil Roth, President of the Pharma & Biopharma Outsourcing Association (PBOA) reflects on the fortunes and challenges of the CDMO sector, highlighting their invaluable place in today’s drug development strategies, and Associates of Cape Cod and Charles River showcase…
In this in-depth focus, learn how to overcome interfering factors when using LAL for endotoxin testing and discover how the implementation of a new scrubs system benefited an aseptic production facility.
The Bacterial Endotoxin Test, using LAL methodology, is a key in-process and final product release test for sterile pharmaceuticals and medical devices. One of the challenges with LAL methodology is overcoming interfering substances as demonstrated by inhibition or enhancement of an endotoxin challenge. Here, Bio Products Laboratory’s Dr Tim Sandle…
In our latest issue, features explore the use of nano formulations to improve skin and nail drug delivery, how to take cell and gene therapies from concept to commercialisation and what strategies you can use to overcome interfering factors in LAL bacterial endotoxin testing. Also in this journal, find out…
