article
Expert view: Current trends in detection of falsified medicines
There is global public health concern over the falsification of pharmaceutical products and the extent to which widespread distribution of substandard drugs has developed...
List view / Grid view
Issue 4 2018
article
Expert view: Therapeutics trends and pharma technologies – in a state of flux
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...
article
Expert view: Environmental monitoring programmes: key tools for risk management
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...
article
Postponement: the solution for biotech packaging
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.
article
Machine learning in biopharmaceutical manufacturing
The biotechnology industry is expected to increase the production of new biopharmaceuticals.1 Biopharmaceuticals require high-quality standards, high initial investments for approval and introduction into the market as well as continued investment in manufacturing.2,3
article
Unlocking the potential of new technologies, such as Lab-on-a-chip, to cut manufacturing costs and boost product development
The investigation and development of new drugs is a time-consuming and rigorous process with many challenges. Every step and each new method is developed with the intention of bringing effective medicines to patients in the shortest possible time, while ensuring the highest possible level of safety. Good product design, as…
article
Understanding the importance of diversity of particle size methods
The particle size of Active Pharmaceutical Ingredients (API) has a significant effect on a drug product’s manufacturability and performance. With respect to manufacturability, particle size can affect compatibility, flowability and blend uniformity; with respect to product performance it can affect solubility, dissolution, and bioavailability.
article
US perspective on the impact of Brexit on the pharmaceutical sector
As the UK prepares to withdraw from the EU on 29th March 2019 at 23:00, this article delivers a US perspective on what Brexit is likely to mean for pharmaceutical companies.
article
Quality Assurance / Pharmaceutical Quality Systems in manufacturing medicinal products
Quality Assurance (QA) covers all aspects that could have an impact on the quality of prescribed pharmaceutical products. This article focuses on some of the Pharmaceutical Quality Systems in relation to QA of manufactured medicines.
article
Specifications and method/process capability: two sides of the same coin
Specifications are defined as “a list of tests, references to analytical procedures, and appropriate acceptance criteria, which are numerical limits, ranges, or other criteria for the tests described”.1
article
Spotlight on… Manufacturing
In this Spotlight on Manufacturing, ACG explains how it meets clients’ changing needs and identifies emerging market trends...
article
Spotlight on… Single use
In this Spotlight on Single Use, David Beattie, Vice President BioProcessing R&D, Merck explains the mode of operation and benefits of its Pellicon® Capsules...
whitepaper
Scientific Poster: Quantitation of monoclonal antibody infliximab in human plasma by LC-MS/MS using Fab-selective limited proteolysis nSMOL technology
Infliximab, commercially known as Remicade, is a chimeric IgG1 kappa monoclonal antibody (mAb), that targets tumor necrosis factor-alpha (TNF)....
article
Avoiding environmental monitoring ‘false negatives’: overcoming disinfectant residues with culture media neutralisers
Even with the rise of rapid microbiological methods, most environmental monitoring applications are undertaken using culture media, with many alternative methods also being growth-based. This makes the selection, control and release of culture media an area of great importance, given that the quality of the culture media underpins the environmental…
article
Software tools that enable confident GC-MS analysis of extractables in pharmaceutical products
Pharmaceutical products come into contact with a wide range of polymeric materials on their journey from the production line to patients. Plastic and rubber contact surfaces are present at almost every stage of a product’s lifecycle: they’re present in single-use systems, such as filters and tubing employed in manufacturing processes;…
