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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.
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
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…
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.
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.
As part of EPR’s Women inspiring Pharma series, Jill Larsen, EVP & CHRO, Medidata Solutions, talks to Science Editor Dr Zara Kassam about addressing the clear challenges facing women in pharma, supporting STEM education initiatives and building crucial relationships...
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.
This article explores how the new draft of Annex 1, Manufacture of Sterile Medicinal Products impacts environmental monitoring programmes.
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
In this Spotlight on Manufacturing, ACG explains how it meets clients’ changing needs and identifies emerging market trends...
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...
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…
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;…
In this issue: Anastasia Petropoulu focuses on some of the Pharmaceutical Quality Systems in relation to QA of manufactured medicines, and Dave Elder looks at method/process capability in terms of QA/QC.
In this issue: the importance of culture media selection, control and realease, how the new draft of Annex 1, Manufacture of Sterile Medicinal Products is impacting environmental monitoring programmes, and software tools that enable confident GC-MS analysis of extractables in pharmaceutical products.
