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Pharma Horizons: leading-edge formulation
This report addresses the key factors shaping pharmaceutical formulation, including regulation, QC and analysis.
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Articles
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...
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.
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
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…
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.
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.
Ensuring diversity is a key part of Medidata’s culture
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 / 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.
How the new draft of Annex 1, Manufacture of Sterile Medicinal Products impacts environmental monitoring programmes
This article explores how the new draft of Annex 1, Manufacture of Sterile Medicinal Products impacts environmental monitoring programmes.
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
Spotlight on… Manufacturing
In this Spotlight on Manufacturing, ACG explains how it meets clients’ changing needs and identifies emerging market trends...
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...
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…
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;…
QA/QC In-Depth Focus 2018
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.
