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.

Heavily focusing on quality in packaging solutions is essential to reduce the risk of contamination. The need for high quality has led to changes in manufacture, such as enhanced inspection processes, tighter production specifications, and the use of automation. The main goal is to deliver more consistent quality and to mitigate the risk of human error and particulates caused by human contamination. By using automation to improve the quality of the end product, the human focus can be shifted towards better design concepts and improved customer interaction – driving other aspects of quality.

I’d like to see pharma companies working more closely with injectables companies to supply briefs with tighter specifications for contamination control, both in manufacturing and delivery. The first stage in this approach would be to establish closer collaborations between pharma and component manufacturers. Many component manufacturers have a deep understanding of formulation, as well as expertise in device development, which means they speak the same language as pharma. Both partners must constantly challenge themselves to deliver the highest standard of cleanliness in elastomer components as demands grow for higher quality medicines. This will require a continuous investment program in quality assurance technologies such as vision systems, robotization and clean room manufacturing.

The industry also needs continued investment in innovation. Film-coated stoppers have emerged that feature a homogenized coating applied during the manufacturing process that can be used to create an effective barrier between the drug and the stopper. Other innovations, such as ready-to-use components, which have been steam or gamma sterilized, can also be directly introduced into restricted access barrier systems or isolators to further guarantee cleanliness for pharma companies.

All of these trends will ultimately result in better, safer injectables for patients.