Ensera has launched a new alliance network designed to help pharmaceutical companies navigate the commercialization of injectable drug-device combination products. The Ensera Alliance Network brings together specialists spanning injector platforms, fill-finish, final assembly and packaging. Its founding participants include device companies SHL Medical, Stevanato Group and Ypsomed, as well as fill-finish providers Argonaut Manufacturing Services and American Injectables.

Ensera said the initiative is intended to address the coordination challenges that can arise as drug developers move combination products from development into commercial manufacturing. Commercializing an injectable combination product can involve several independent suppliers, with pharmaceutical companies often required to coordinate activities across device selection, drug-product manufacturing, assembly and packaging. Ensera said gaps between these stages can create additional project-management demands and complicate the transition to commercial supply. The new network is intended to provide closer collaboration between the companies involved in those activities, allowing project teams to coordinate requirements and identify potential issues earlier in the commercialization process.

“Too many combination product programs are slowed by disconnected suppliers and difficult handovers,” says Bobby O’Connor, chief commercial officer at Ensera. “The Ensera Alliance Network brings trusted specialists together around a more coordinated, responsive model, helping customers simplify commercialization, reduce risk and rapidly progress towards launch.”

Darren Hieber, vice president of alliance partnerships at Ensera, said the network builds on existing relationships between the participating organizations. “This network has been built on established relationships, shared experience and a practical understanding of how each organization operates,” Hieber says. “By connecting partners across device platforms, fill-finish, final assembly and packaging, we can work more collaboratively around the needs of individual programs, identify challenges earlier and help customers navigate the transition towards commercial supply.”

Ensera said it expects the network to grow, with additional organizations potentially joining as the needs of pharmaceutical customers evolve. Future participants will be selected based on the compatibility of their capabilities, standards and operating approach with the existing network.

Membership in the alliance is non-exclusive. Ensera and participating companies will continue to operate as independent organizations, and pharmaceutical customers can work with individual network members directly and independently.

The launch comes as drug developers increasingly manage commercialization programs in which the drug product and delivery device must progress through multiple interconnected manufacturing and supply-chain stages before reaching the market.

For additional information, visit www.ensera.com.