Vial Containment Solutions

At West, we pride ourselves for our passion for our customers. We work hard to be by the side of their journey to ultimately create a healthier world. Our customers, both big and small, work every day to help patients with various diseases, syndromes, and conditions live a better life. We consider the success of our customers to be our success as well.

The need for advanced containment solutions, and novel fill-finish processing to enable implementation of these solutions, continues to grow as more complex drug products enter multiple pipelines. As biotech companies develop these complex drug products, the integration of product and process knowledge is crucial to delivering product safety, quality, identity, potency, and purity. And as biotech companies seek partners to help accelerate their development processes, West is committed to leading multi-disciplined, high-performance teams in developing optimal fill-finish solutions for novel packaging and container systems. This dynamic partnership is well-illustrated by the following case study.

Liquid injectable drugs can be contained in a pre-filled syringe system, a cartridge-based system, or a vial-based system (with a rubber stopper and seal). For a vial-based system, the drugs first are aseptically filled into glass or polymer vials. During the subsequent Fill & Finish operations, the vials are closed temporarily by inserting a rubber stopper into the vial orifice. This is prior to crimping with an aluminum seal, which results in the final integral vial-based container closure system.

An enormous growth trend is being observed in the market for biologic drugs; they are being employed ever more frequently as treatments for chronic issues such as cancer and autoimmune diseases. This growth is reflected by the number of companies involved (established and emerging), and in the capital investment for manufacturing facilities for both biologics and biosimilars. Companies must apply a holistic approach to bringing a biologic drug to market. 

Cell therapies show tremendous promise for the treatment of a variety of life-threatening diseases. Their approvals are increasing. Because cell therapies are extraordinarily expensive, it is imperative that the primary packaging system maintain integrity through the shelf life.

Unanticipated incompatibilities between the drug product and a closed system transfer device (CSTD) delay therapeutic delivery to the patient. Considering the CSTD with the drug product and even co-packaging the drug product with an optimal FDA-approved CSTD will positively impact drug product therapeutic performance and ultimately patient care.