For many vaccine manufacturers, the emergence of H1N1 has exemplified some of the benefits to be gained from outsourcing. When rapid process development is required, having an active partnership provides an on-call source of experienced shovel-ready capacity. But reduced time-to-market is only one of the many benefits provided by partnering.
The ability of the sponsor to either maintain a capacity buffer or reduce backlogs as well as the ability to focus on its particular core capabilities are examples of the more indirect value that can be gained by outsourcing. There are also times when a partner’s geography can assist in the transfer or establishment of operations in a new location. Finally, potential financial benefits exist, such as in shifting fixed to variable costs, or if the price of such outside services is lower than in-house costs.
In addition to the immediate project goals, strategic partnering should also take into consideration operational excellence. Quality guidelines that are under development are expected to force the industry to mirror other process-based manufacturing operations that have for years been focusing on minimizing product and process variability.
To become realized, ambitious goals such as continuous quality verification and RTR require access to a number of tools and prerequisite developments.
Once the decision to outsource has been made, a number of factors need to be considered in the choice of an effective partner, including the sponsoring company’s general operating style, its strategic goals, its existing project-relevant capabilities, and specific development or optimization project goals.
The nature and scope of service provider capabilities and characteristics are surprisingly diverse. Depending upon the sponsor’s expertise and goals, firms need to evaluate their potential partners’ attributes, including in-hand process-monitoring technologies, control system expertise, the experience of available personnel, and capacity to manufacture and supply materials defined in the project.