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In this article, Dave Elder reviews the European Medicines Agency (EMA)’s updated reflection paper on the qualification of non-mutagenic impurities (NMIs), which outlines alternative approaches to animal testing.
In this Spotlight on Continuous Manufacturing, MG2 explains why they are the single partner clients need for all productions into hard-shell capsules...
Butterworth Laboratories provides outsourced analytical chemistry services to the global pharmaceutical and related industries, specialising in raw materials analysis. It has expertise in complex wet chemistry techniques, extensive experience in residual solvent analysis, and full instrumental capability in elemental impurity analysis.
This In-Depth Focus examines methods to improve efficiency on the production line and explores a LC-MS based multi-attribute method for characterisation and QC testing of protein therapeutics.
In this Spotlight on Continuous Manufacturing, GEA explains how they have developed a deep and thorough understanding of the challenges clients face, the hurdles they need to overcome and the goals they want to achieve...
Specialising in chromogenic and turbidimetric reagent technologies, Associates of Cape Cod, Inc. (ACC) has been a leader in endotoxin detection products and services for nearly 45 years. ACC pioneered LAL testing methodology and was the first FDA licensed company to manufacture LAL reagents; ACC has grown to be an internationally…
This issue features articles on Burkholderia cepacia complex, culturomics and metagenomics, and evaluation of microbiological purified water trend using two types of control chart.
In this Spotlight on Continuous Manufacturing, G-Con explains how they have simplified the entire design/build/validate process via their prefabricated cleanroom infrastructure line...
Welcome to European Pharmaceutical Review’s roundtable devoted to continuous manufacturing. We have brought together six industry experts to focus on how the contribution of continuous manufacturing technology is shaping the pharmaceutical sector and explain what factors are driving that change.
In this edition of our 'Guide to' series, five leading companies that provide outsourcing services explain how their portfolio meets current industry needs.
Welcome to European Pharmaceutical Review’s Spotlight on Continuous Manufacturing.
In this issue: LC-MS multi-attribute methods for the characterising and QC testing therapeutics, integrating data from Quality Control and Production to enable fast and informed decisions, and Solid-state NMR spectroscopy: using freeze drying to predict the stability of biological products.
There is global public health concern over the falsification of pharmaceutical products and the extent to which widespread distribution of substandard drugs has developed...
The global pharmaceutical industry has been expanding steadily at varying rates of regional growth; the pace of growth being relatively slow in the developed, matured markets but rapid in developing nations...
Environmental monitoring programmes are all about risk management. Use of risk management techniques and a thorough understanding of the processes in the laboratory can assist in identifying any problematic areas...
Postponement packaging, or late-stage customisation, is the supply chain practice of keeping a product in a standard format for as long as possible, only making it market specific – or even customer specific – at the moment demand arises.
