High-potency drugs – challenges and factors
High-potency drugs present numerous opportunities for improved drug selectivity, efficacy and safety profiles.
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Articles
SGS experts help to mitigate the risk of nitrosamine impurities in drug products
The identification of N-nitrosodimethylamine (NDMA) in an active pharmaceutical ingredient (API) in 2018 not only led to regulatory warnings and product recalls, but wider recognition that pharmaceutical manufacturers should adopt a proactive approach to risk assessment and mitigation in relation to genotoxic contaminants.
Your endotoxin experts
Specialising in chromogenic and turbidimetric reagent technologies, ACC has been a global leader in endotoxin and (1→3)-ß-D-glucans detection products and services for more than 45 years.
Global, award-winning insourcing
Eurofins PSS Insourcing Solutions® (PSS) employs and manages full-time scientists, managers and support staff to perform a defined scope of work at a client’s facility.
Expert view: The right endotoxin detection solution for you – bioMérieux’s complete portfolio of rFC endotoxin assays
As part of any general pyrogen testing strategy, the detection of even minute traces of the highly pyrogenic bacterial molecule called lipopolysaccharide (LPS, also named endotoxin) in pharmaceutical samples is mandatory to ensure patient safety.
Data integrity: an opportunity to improve classical microbiological methods
Data integrity (DI) continues to trend as a hot topic for pharmaceutical manufacturers, despite the fact it is an expectation that has been present for years.
Bioprocessing & Bioproduction In-Depth Focus 2020
Articles in this in-depth focus discuss the challenges facing advanced therapy medicinal product developers and which leadership qualities could be implemented to drive innovation in biologics.
Manufacturing, Packaging & Logistics In-Depth Focus 2020
In this in-depth focus explore the implications of Trump's 'Buy American’ order for drug manufacturers, how researchers step-up metformin production from lab to industry scale and a discussion on how advanced planning could enable pharmaceutical production to be scaled up.
Formulation, Development & Delivery In-Depth Focus 2020
In this in-depth focus experts provide guidance on how to select starting materials for API's and discuss how to specify exipients to reduce downstream regulatory burdens.
QA/QC & Analytical Techniques In-Depth Focus 2020
Read articles on validating rapid microbial methods according to regulatory requirements and how solid-state NMR spectroscopy can be used to analyse pharmaceuticals in this in-depth focus.
Guide to Outsourcing
Welcome to European Pharmaceutical Review’s Guide to Outsourcing. In this edition, Eurofins Scientific, SGS Life Sciences, Charles River Laboratories, ACCI, Eurofins Amatsi Group and Thermo Fisher Scientific showcase their unique outsourcing services and discuss how they stand out from the competition.
European Pharmaceutical Review Issue 5 2020
In this issue you can find articles discussing the supply chain implications of Trump's 'Buy American' order, guidance on how to identify and justify starting materials for regulatory approval by both the EMA and FDA, as well as some of the latest developments in oral biologic drug delivery techniques. Also…
Speeding processes and enhancing compliance with pharmacovigilance automation
Dr John Price explains how life sciences companies are making progress with pharmacovigilance automation and how a new study of pharmaceutical organisations has uncovered potential for improvement in the capture of adverse event data.
Who will receive COVID-19 vaccines first?
EPR’s Hannah Balfour discusses some of the proposed COVID-19 vaccine distribution plans and how medicinal nationalism and supply deals could prevent “fair and equitable access” to COVID-19 vaccines.
Reality check: is robotic process automation a panacea for transforming regulatory affairs?
Regulatory operations are burdened by resource-draining document and data processing tasks, but is robotic process automation the definitive solution? If not, where does it have greatest application and appeal – and how can life sciences firms exploit the full benefits? Agnes Cwienczek scrutinises the technology’s potential.
