The impact of COVID-19 is wide-reaching with disruptions to supply chains likely to continue over the coming years. In this article, Dave Elder discusses the effect of the pandemic on the supply and demand of critical medicines and what this means for pharma supply chains.
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The increasing use of subcutaneous administration stems from the significant advances in biological drug development, as well as the rising trend of self-administration.
As a world-leading drug device combination solutions specialist, our purpose of putting patients first enables us to design and manufacture devices that maximise treatment efficacy.
High-potency drugs present numerous opportunities for improved drug selectivity, efficacy and safety profiles.
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.
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.
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 (DI) continues to trend as a hot topic for pharmaceutical manufacturers, despite the fact it is an expectation that has been present for years.
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.
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.
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.
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.
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.
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…