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Insights

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.

Insights

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.

Insights

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.

Insights

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.

Insights

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.

Insights

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.

Insights

Rafael Hartmanna, Jonas Malmströma, Graham Sibleyb and Fredrik Lehmann
  Syn lett, R. Hartmann et al. 20.01.2016

Insights

The risk of failure and cost invovled with developing new pharmaceutical products can be significantly reduced by using existing active ingredients in the development process and choosing the right partner for the development of the specific requirements of microtablets is crucial.