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Manufacture Drug Delivery, Packaging, Quality & Compliance

Driving Quality in Injectables

Upon examining the pipelines of pharmaceutical companies, growth in the injectables field is undeniable. It is well known that many companies today are focusing on biologics – the vast majority of which require injection. The sensitivity of biologic drugs has a direct impact on primary packaging requirements, and tighter particulate specifications and more inert solutions are at the forefront of manufacturers’ needs. Subsequently, coated packaging solutions are often chosen as a mandatory safe solution since they provide a higher reduction in particulates, limiting the risk of drug interactions and enhancing drug compatibility. Although there is no 100 percent barrier for contamination, coated packaging solutions are seen by many as critical to improving the cleanliness for sensitive drugs.

In my view, one of the biggest trends in injectables is the patient-centric move towards pre-filled systems and self-injection devices, which support independence, ease-of-use, and effective treatment. Biologic drugs are incredibly expensive, so healthcare systems have needed to find alternative ways to cope; enabling patients to self-administer their own drugs can reduce costs, as trained professionals are not required. However, this also limits the patient-healthcare provider interface, necessitating easy-to-use and self-explanatory primary packaging. A growing number of drugs use pen injectors or autoinjectors, which has led to a rise in more rigorous user or human factor studies. These studies are a necessity to get primary packaging right the first time – as is quality.

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About the Author

Arnaud Forunier

Arnaud Fournier is Senior Business Support Manager, Injectables Division, at Aptar Pharma.

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