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How Mylan is meeting challenges in sustainability
Mylan works with industry associations and key stakeholders to improve sustainability of the healthcare system. Jacek Glinka, President, Mylan Europe, explains how...
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Manufacturing
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Allergan: Living bold and doing what’s right
Marc Princen, Executive Vice President and President Allergan International, explains how Allergan’s novel ethos and innovative approach makes it stand out from the crowd...
whitepaper
Application Note: Raman spectroscopy as a process analytical technology for pharmaceutical manufacturing and bioprocessing
Adoption of Quality by Design (QbD) principles, regulatory support of QbD, process analytical technology (PAT), and continuous manufacturing are major factors effecting new approaches to pharmaceutical manufacturing and bioprocessing...
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Sanofi: Unravelling the complex, together
Sanofi has long been at the forefront of the drive to find new, innovative solutions for patients in different therapeutic areas, such as diabetes, cancer, cardiovascular diseases or rare diseases. Marc-Antoine Lucchini, SVP Diabetes and Cardiovascular Europe and Coordinator, Sanofi Europe, discusses some of the company’s achievements...
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Objectionable organisms in non-sterile medicinal products
Microbiological contamination of non-sterile medicinal products is an infrequent, but longstanding and recurring issue. But there is no ‘one size fits all’ approach towards objectionable organisms, says David Elder...
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The future of bioanalysis with microchip chromatography
Much rests on the further development of bioanalytical technologies which allow the highest level of sensitivity on small samples, and robust, high reproducibility across large populations. Johan Devenyns, CEO PharmaFluidics, explains further...
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Rapid testing methods: the cost-effective safety solution
When thinking about the future of the pharmaceutical sector, it can be difficult to pinpoint a specific focus as there are a wide range of challenges that come into consideration across all stages of development and manufacturing. Dr Lynne Murdoch, Business Manager – Microbiology, Wickham Laboratories, considers some key points....
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Pfizer: Concentrating on core areas to improve lives
For Pfizer, putting patients first guides its actions, informs its strategic decisions and unifies colleagues in every region and function across the company. Beatriz Faro, Regional President, Internal Medicine, International Developed Markets at Pfizer, explains how the company’s philosophy is taking the business forward...
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Hot melt extrusion technology for continuous manufacturing
Hot melt extrusion (HME), a manufacturing technique traditionally used in the plastic and food industries, is now attracting significant interest from the pharmaceutical manufacturing sector. This is primarily because HME enables the continuous manufacture of a wide variety of dosage formulations, including solid dose form, which is of particular importance…
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What do we need from PAT?
Pharmaceutical manufacturing in the modern era is facing unprecedented demands, including in-depth scrutiny of production methodology, and inefficiencies in current practices with respect to waste, energy usage and time management. Coupling this with increased complexity in the manufacture of newer products and the decline of blockbuster drugs, results in an…
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The importance of critical quality attributes in Quality by Design for rapid bioprocess development strategies
QbD and PAT could revolutionise the way biopharma industries operate by cutting down their attrition rates, which could drastically change their business model. This article considers the issues involved.
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Interview: Why is Data Integrity at the heart of the industry
How are you addressing risk management and data integrity...
whitepaper
Application Note: Analysis of extractable and leachable metals in plastic materials of construction as per USP <661.1>
Plastic packaging systems for pharmaceutical use include, but are not limited to bags, bottles, vials, ampoules, cartridges, dry powder and metered dose inhalers, syringes, blisters, pouches and their associated closures and secondary components like labels and printing overpouches...
whitepaper
Whitepaper: Perform conductivity measurements in compliance with USP <645>
“Water is the most widely used substance, raw material, or ingredient in the production, processing and formulation of compendial articles...”
whitepaper
Whitepaper: Cleaning validation – what do you need to consider to ensure a successful outcome?
This white paper discusses the over-arching strategy for performing a successful cleaning validation, with detail on some of the key factors to consider at both the manufacturing, microbiological and analytical stages, highlighting many common pitfalls to avoid..
