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Issue 3 2019

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Digital design for pharmaceutical product and process development

1 July 2019 | By , , , , ,

New digital design and manufacturing techniques offer pharmaceutical manufacturers the possibility of a systems-based, digital approach to substantially streamline their design, development and manufacturing processes. The ADDoPT collaborative consortium has been working to explore how emerging process understanding and predictive models can be applied and embedded within industrial workflows to…

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Manufacturing medical devices to ISO 13485:2016

1 July 2019 | By

Continuous innovation is key to the advancement of medical device technology. To allow for innovation, whilst also assuring safety and effectiveness, global standards are required. This article provides information for companies manufacturing medical devices on the benefits of holding ISO 13485 certification and how to get certified.

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Implementing global standards to ensure end‑to‑end FMD compliance

1 July 2019 | By

Effective drug serialisation and identification is essential for improving the safety of medicines and combatting counterfeits. The Falsified Medicines Directive’s new requirements promise to crack down on the impacts of unsafe drugs. Neil Piper discusses the human cost of falsified medicines and how companies need to increase traceability of individual…

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Expert View: Eshmuno® CP-FT resin – developed for the flow-through removal of aggregates using frontal chromatography

28 June 2019 | By

Eshmuno® CP-FT cation exchange resin is specifically designed to provide efficient removal of monoclonal antibody (mAb) aggregates in the flow-through frontal chromatography mode of operation enabling loading capacities 10-times higher than traditional bind/elute CEX chromatography. It facilitates greater manufacturing flexibility and process intensification while reducing the overall cost for the…