The growing use of CROs in many areas of product development is well known. Some estimate that up to one-third of drug development activities may soon be contracted out. More recently such outsourcing has extended to other activities, including the optimization of bioproduction materials and processes. This increased use of outsourcing ranges from recombinant clone selection to final product fill and finish.
Both heightened and entirely new process design criteria from a variety of sources are contributing to the increased interest in bioproduction outsourcing. Quality by design (QbD) and operational excellence (OpEx) in general, and such quality initiatives as PAT and ICH Q8–9 in particular, are providing new tools, as well as new goals in bioprocess development. These goals include such exciting prospects as more rapid and comprehensive process monitoring, in-process QC, and real-time release (RTR).
The shift toward platform-type approaches and manufacturing campaigns is driving the requirement that processes be both robust and flexible. In addition, advanced technologies are creating a need for specialized subject-matter experts in some areas of process development.
Advances in cell culture-based production include use of automation in clone selection, disposable formats in standard and flexible seed train design, defined and animal product-free basal production media formulations, high-efficiency materials in fed-batch production, and chemistries that maintain increased product quality through harvest.
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.