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The enforcement of the EU Falsified Medicines Directive (FMD) in February 2019 saw the serialisation of pharmaceutical products become a legal requirement.

Industrialising inhalation products requires specialist knowledge, a comprehensive manufacturing strategy and comprehensive product maintenance in order to overcome potential hurdles during commercial scale production.

Archie Wall,  Karl Nicholls, Mikael B. Caspersen, Stig Skrivergaard,  Kenneth A. Howard,  Kersti Karu,  Vijay Chudasama and James R. Baker
  Org. Biomol. Chem., 2019, Advance Article

With the ability to control the rate and site of drug release to reach clinical objectives that cannot be achieved using conventional dosage forms, modified-release (MR) drug delivery offers many advantages.

While the development of new inhalation therapy drugs is growing in popularity, the tech transfer and scale-up stages present several complexities that are difficult for manufacturers to manage.

Following the enforcement of the EU Falsified Medicines Directive (FMD) in February 2019, serialisation is a legal requirement for pharmaceutical products.

The increasing potential of pulmonary routes of administration for local therapies is driving the development of inhalation drug products. However, developing treatments with this delivery mechanism presents several challenges for manufacturers.

The development of an antibody drug conjugate (ADC) is more unpredictable than that of a small molecule new chemical entity (NCE). As a result, the industry needs to invest in more vital research before conducting expensive clinical programs.

Of course, in a shifting regulatory environment with evolving customer demands, CDMOs must always be thinking about what is next.

Karthik Selvaraju, Arjan Mofers, Paola Pellegrini, Johannes Salomonsson, Alexandra Ahlner, Vivian Morad, Ellin-Kristina Hillert, Belen Espinosa, Elias S. J. Arnér, Lasse Jensen, Jonas Malmström, Maria V. Turkina, Padraig D’Arcy, Michael A. Walters, Maria Sunnerhagen & Stig Linder
  Scientific Reports 9, Article number: 9841 (2019)