The overall quality of a final drug product depends on the components of its packaging and delivery systems.  The use of visually inspected components reduces the risk of defective components and helps ensure patient safety.

Containment/delivery systems for sensitive biologic drugs must provide the chemical, physical, and performance properties required to ensure product quality through shelf life. Further, they must be compatible with fill/finish operations, and enable functional performance during administration. Legacy rubber components may no longer meet the increasing technical and regulatory requirements of current and future biologic drug products.

The recent growth of self-administration devices has provided the opportunity to truly change the landscape in drug delivery. These devices, such as auto-injectors, not only allow for more patient convenience, but also enable different dosing regimens and types of therapies that can now be injected via auto-injector. These advantages are why the auto-injector segment is the fastest growing delivery segment, and the majority of top selling drugs are delivered via PFS/auto-injector.

Biologic drug products are not new – their development began decades ago; the first monoclonal antibody was commercialized in 1986. ^[1] With the increasing availability of genetic information, and better understanding of subcellular cascades and disease processes, the number of biologic drug products available has increased substantially in response to an exponential growth in targets. ^[2]

Industry meetings continue to reinforce the changing landscape of the drug pipeline and the influence of biologic drug products in driving this change.  At the recent DCAT Week, hosted by the Drug, Chemical and Associated Technologies Association, Josef Bossart, of PharmaCircle, provided an excellent overview of historic trends and current forecasts.

Ever wondered what West’s cutting-edge product development facilities look like on the inside? Jeff Kyle, Sr. Director New Product Introduction, and Tom McLean, VP Delivery Systems R&D, take you behind the scenes of the Scottsdale, AZ plant.