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Drug stability testing is one of the most important parts of the drug production process. These tests aim to determine the performance of a drug under different conditions, such as humidity, sunlight and temperature, and therefore help to decide safe expiry dates.

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The biggest challenge is often ensuring that limited time, effort and resources are spent developing a suitable formulation for Phase 1, and at the same time ensure that these results pave the way for further development into Phase II/III.

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As the industry continues its preparations for the European Falsified Medicines Directive (FMD), Recipharm has reached another important milestone in its journey to serialisation compliance.

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Antibody–drug conjugates (ADCs) are an emerging type of biotherapeutics that utilize multiple tissue specific antibodies combined with a range of linker designs to enable the transportation and selective release of cytotoxic drugs in close proximity to tumours.

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Ulf Bremberg, Johan Eriksson-Bajtner, Fredrik Lehmann, Viveca Oltner, Ellen Sölver, and Johan Wennerberg
  Org. Process Res. Dev. 2018, 22, 1360−1364

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At FutureLink Munich 2018, a survey regarding serialisation and the EU’s Falsified Medicines Directive (FMD) was conducted. Over 1600 responses were submitted from more than 200 pharmaceutical and healthcare executives, with many indicating that the industry is not as prepared as it should be for the new regulation.

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In general, the barriers faced by Recipharm will be the same across the pharma industry, the most difficult of which being financial.

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Following the EMA’s most recent survey, which concerned pharmaceutical companies’ preparedness for Brexit, it became apparent that very little guidance had been given to businesses on how best to prepare for the change.

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The introduction of more thorough quality control regulations is changing how companies test drug stability, with more and more turning to outsourcing for efficiency. Stability studies are among the most important in the drug production process, as they influence planning production and expiry dates.

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In response to the UK’s decision to withdraw from the European Union, the European Medicines Agency (EMA) will relocate from London, UK to Amsterdam, the Netherlands in less than six months’ time.