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Dave Elder outlines how bioequivalence data supports numerous processes at various stages of drug development as well as when establishing generic drug substitution, and reflects on its differing interpretations across the globe.
Learn about how SampleManager LIMS software drives compliance and data integrity by providing clear traceability for all laboratory activities and data.
In this virtual roundtable, Scott Bradley (Principal Research Scientist, Eli Lilly and Company), Joan Malmstrøm (Principal Scientist, Novo Nordisk) and Kelly Sackett (Principal Scientist, Pfizer) exemplified how high-resolution nuclear magnetic resonance (NMR) is a key technology that provides critical information about protein structure and dynamics. Here, the participants offer some…
Welcome to European Pharmaceutical Review’s Guide to Data Integrity. In this edition, Ian Harrow and Thomas Liener, Consultant Project Managers at The Pistoia Alliance, explain the importance of the FAIR data principles; and Charles River Laboratories and Thermo Fisher Scientific showcase their unique data integrity services and discuss how they…
Francesco Berti, Scientific Director at GSK Vaccines - Siena, Italy, reveals how NMR spectroscopy tools are invaluable in vaccine production.
In this journal, features on the current regulatory positions on nitrosamine impurities, how investing in off-patent medicines can help drive innovation and why new regulations could lead to a biosimilar boom in the UK. Other articles include an exploration of the challenges in developing and delivering lipid nanoparticle mRNA-based vaccines,…
Endotoxin automation doesn’t mean complex instrumentation and setup. See how microfluidics enables easy BET assay setup so QC labs achieve high throughput with less hands-on time.
A rapid sterility test method that can be validated as quickly and confidently as it provides test results.
EU recommends that batches of Janssen COVID-19 Vaccine not be released for use due to a cross contamination report, while the FDA authorises use of drug substance from the facility where the contamination occurred.
This webinar presents the fundamentals of a contamination control strategy including forms of contamination, as well as cleaning and disinfection.
9 June 2021 | By Tecan
This on-demand webinar brings three leaders in the field together to discuss the new regulations, responsibilities across the whole supply chain, documentation, the notified body application process and key timelines.
The continuous-flow microfluidic device allows scientists to assess crystalline API growth rates, shapes and structures to more quickly identify the best conditions for drug manufacturing.
From traditional LAL assays to cartridge-based systems, robotics and microfluidic BET automation, learn how different endotoxin testing systems work in this infographic.
In this article, Dr Ash Ramzan, principal consultant at Woodley BioReg, discusses the five key challenges preventing biosimilars from reaching their full potential.
This ebook from Sartorius takes an in-depth look at how the quality control (QC) microbiology laboratory plays a critical role in control of the pharmaceutical manufacturing environment and product release.
