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Oral solids remain the dominant dosage form in the pharmaceutical market. They are used across the entire spectrum of pharmaceutical candidates and products owing to their extensive benefits including; cost-effectiveness, patient compliance, increased chemical and physical stability, convenience of handling and controlled release options. 

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There is an opportunity for consolidation to help customers reduce their supplier base.

The trend of life science pharmaceutical companies partnering up with contract development and manufacturing organisations (CDMO) has grown as newer and smaller companies turn away from investing in large scale in-house production and instead outsource manufactur

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Scale, breadth and depth of services will always be key drivers for pharmaceutical outsourcing, and CDMOs that can offer a wide range of technologies and expertise are uniquely placed to act as a one-stop-shop partner.

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If the industry does not get to grips with serialisation soon, it could be too late.

With the US deadline for pharmaceutical serialisation just around the corner and the EU regulations due to come into force in 2019, track and trace implementation is set to be a major topic for 2017.

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Inhalation formulations are becoming increasingly popular due to their ability to deliver pharmaceuticals directly to the nasal passage or lungs in small doses, mitigating the risk of side effects and minimising drug-to-drug interaction.

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Despite the huge task of implementing new serialisation technologies and processes, many pharmaceutical companies have delayed involving contract partners in their serialisation efforts, adopting a ‘wait and see’ approach.

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Excipient selection strongly influences lyophilisation performance for biologic drugs.

Lyophilisation, or freeze drying, is a well-recognised method for delivering stable biologic drug products that have short shelf-lives in solution form.

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As a result of increasing concerns over falsified medicines, reimbursement fraud and theft throughout the pharmaceutical supply chain, by 2019 over 55 countries will have introduced serialisation and track and trace regulations. With varying legislation coming into force across the globe, understanding the requirements of the markets you operate in is of paramount importance.

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Lars G. J. Hammarströ m, Robert K. Harmel, Mikael Granath, Rune Ringom, Ylva Gravenfors, Katarina Farnega, Per H. Svensson, David Wennman, Göran Lundin, Ylva Roddis, Satish S. Kitambi, Alexandra Bernlind, Fredrik Lehmann, and Patrik Ernfors
  Journal of Medicinal Chemistry, 2016, 59, 8577−8592

Insights

The many challenges faced by the pharmaceutical industry throughout the supply chain, including fraud and counterfeit medicines, have led to international serialisation requirements in the U.S and Europe. With this in mind, CDMOs have a lot to consider with the new track and trace regulations.