PD ORGANIZATIONAL STRUCTURES
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.
Figure 1: Fully-decentralized process development (PD) structure. (ALL FIGURES ARE COURTESY OF THE AUTHORS)
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
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.
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 2: Site-focused process development (PD) integration. (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
Figure 3: Global functional alignment of process development (PD). (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.
Figure 4: Fully-centralized process development (PD) structure. (ALL FIGURES ARE COURTESY OF THE AUTHORS)