Organizational Structures of Process Development and Manufacturing Support - How to strike a balance between site autonomy and global coordination. - BioPharm International


Organizational Structures of Process Development and Manufacturing Support
How to strike a balance between site autonomy and global coordination.

BioPharm International
Volume 24, Issue 9, pp. 32-36


Figure 1: Fully-decentralized process development (PD) structure. (ALL FIGURES ARE COURTESY OF THE AUTHORS)
A PD structure that gives priority to site autonomy is shown in Figure 1. The assumption is that PD departments exist at various locations (Sites A, B, and C). One of the sites may play the role of a central or corporategroup. Another assumption is that each PD department is organized functionally into subgroups, including cell culture, purification, and formulation–fill–finish units. Not all functions may exist at any one site, however, this structure is considered for completeness. In some organizations, other functions can be part of PD (e.g., analytics, cell-line development, and pilot plant), but for simplicity, these are not included in Figure 1. Well-developed analytical function is a critical element of PD, and usually all PD departments have an analytical group that provides routine assay support. However, the location of the assay-development activity varies significantly from company to company.

According to this model, each PD group reports into the local site head, who reports to a corporate executive, fully empowering site autonomy. The line responsibility for the coordination and alignment between the PD groups from different sites is moved high up in the company hierarchy to the level of the corporate executive. Except for various teams and committees that can help the cross-site alignment, no formal links support global coordination. While this model facilitates speed and focus on site priorities, it does not adequately support global alignment and integration of the PD organization. This type of organization creates silos of PD resources and minimizes the opportunity for setting common priorities and flexible distribution of projects and resources.

The model in Figure 1 may work well when different sites use completely different technology platforms, which makes the need for harmonization less critical. However, usually the platform technologies are similar, particularly when one product is manufactured at multiple sites. In this circumstance, decentralization may create problems, such as incremental technological drift of sites away from each other in terms of procedures, methods, instrumentation, and development philosophy. When left unmonitored, this drift can be difficult and costly to reverse.

Figure 2: Site-focused process development (PD) integration. (ALL FIGURES ARE COURTESY OF THE AUTHORS)
The second model (see Figure 2) shifts the balance towards centralization. Each PD group reports into a global PD head, who is responsible for all PD activities in the company. Site management still can have an administrative link to the local PD groups, usually achieved through dotted lines. The global PD head is responsible for the coordination and alignment between sites, which is an essential part of his or her role. The focus on integration is stronger, and the responsibility for it is shifted lower in the company hierarchy.

Figure 3: Global functional alignment of process development (PD). (ALL FIGURES ARE COURTESY OF THE AUTHORS)
The third model (see Figure 3) provides full functional alignment. The responsibility for coordination is moved to an even lower level. For example, all cell-culture PD departments at different sites report to a global cell-culture head. The other functions are integrated similarly. This model provides a high level of coordination, which is rooted deeper in the organization. Furthermore, it requires a symmetrical organization of all PD groups, which streamlines communication, responsibility, definition, and resource allocation. This model is generally appropriate for more mature organizations where all PD departments are already functionally structured.

Figure 4: Fully-centralized process development (PD) structure. (ALL FIGURES ARE COURTESY OF THE AUTHORS)
The fourth model (see Figure 4) represents a fully centralized PD organization that assumes colocation of all PD resources at one place. With the objective of maximizing coordination, some large companies have elected to concentrate all their development activities at a single site. Clearly, this structure defines the opposite end of the organizational spectrum compared with the fully decentralized model depicted in Figure 1.

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