The successful evolution of biotech companies has resulted in their expansion into complex multisite international structures.
This transformation requires the establishment and coordination of various distributed functions, including manufacturing,
manufacturing support (MS), and process development (PD). While such decentralization may offer some advantages, such as fast
responses to local crises, use of local talent, cost reductions, and certain regulatory benefits, decentralization also poses
significant organizational challenges. To address these challenges, companies have to find the right balance between site
autonomy and functional centralization, so that the potential of each site is fully enabled, while a high level of coordination
between sites is maintained. This article analyzes several structural alternatives for global PD organization, versions of
which can be found in the biotech industry today. Two global structures that can potentially provide a practical solution
for most cases will be proposed. These models are idealized, not reflecting any particular organization. Although this discussion
focuses on PD, some of the solutions are fully applicable to MS. In the long term, the global PD and MS functions are unlikely
to remain static. The evolution of every company requires periodic review and optimization of PD and MS, so that they adequately
reflect the needs, size, and the maturity of the organization as it becomes a well-engineered global enterprise.
The authors discussed the PD organization structure issues with the management of multiple large biotech and biopharmaceutical
companies involved in therapeutic protein manufacturing (1). The focus was on the following:
- Definition of responsibilities, in particular in the area of overlap between manufacturing and development
- Global structures of PD and MS
- Allocation of PD and MS functions in the global decentralized company
- Additional cross-functional means for enhancing coordination.
While all companies have their own structures, there are general concepts and patterns that are reproducible. Using the gathered
information in combination with the authors' own experience, organizational models were developed that cover a broad spectrum
of options spanning from complete decentralization to full centralization. These models do not represent the structure of
any particular company, but capture the essence of the existing opportunities.
The existing structures are not static but continue to evolve, thus reflecting the progress and the specifics of each organization.
Despite many differences, often resulting from the personal preference of top management, there is a clear trend towards global
Most companies have separate MS and PD functions. Furthermore, the MS groups are always colocated with the manufacturing departments
they are supporting. Because this model is common and offers some important advantages, the authors considered it as a standard
in the analysis. The advantages of this approach include speed of response to urgent manufacturing needs and shielding of
PD from short-term daily problems in the plant, so that resources are focused on long-term strategic projects and innovation
(2). In some cases, a central MS group is responsible for the coordination and standardization between the distributed MS
Table I summarizes the responsibilities of the MS and PD groups. In this illustration, the MS groups serve as the first line
of defense. Because speed is one of the main requirements, local presence, including on-the-floor support, is essential. MS
focuses on the manufacturing processes at the particular site and is often a structural part of the manufacturing organization.
It is responsible for the day-to-day issues, including deviation investigations, continuous improvement, process monitoring,
data mining, and process transfer to the local site. Typically, MS is not involved in complex, exploratory, long-term projects.
These projects are handled by PD, and developed in close coordination with MS and manufacturing.
Table I: Responsibilities of process development (PD) and manufacturing support (MS).
On the other hand, PD is responsible for larger life-cycle management projects, development and transfer of new processes,
new technology platforms, and manufacturing support of complex projects requiring intense experimental and analytical work.
The PD group can be centralized or decentralized, residing at several sites that provide remote services to various internal
While a definition of the responsibilities of MS and PD is helpful, it is difficult to define a clear line between the two.
Accepting a certain level of healthy overlap and ambiguity is practical, because this can serve as a bridge between the two
functions, thus preventing dangerous gaps. The complexity of biotech manufacturing results in a continuum of projects, some
of which cannot be clearly allocated to only MS or PD.
The coordination between MS and PD is a critical element of the biotech enterprise. Structurally, these groups exist as independent
departments under different management. As such, it is essential that their activities, procedures, objectives, priorities,
and methodology be aligned. This alignment can be achieved by properly designed business processes involving both organizations,
including but not limited to joint teams, committees, periodic reviews, and symmetrical functional structures. Proper alignment
allows for an optimal response to rapidly changing priorities, fluidity, coordinated resource allocation, and global utilization
of knowledge generated at different locations.