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

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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

MS STRUCTURES

The MS models can be similar to these of PD, with the exception that the MS groups by definition are colocated with their corresponding manufacturing units. Therefore, the fully centralized model (see Figure 4) is not applicable. Although individual MS groups are ultimately focused on supporting their local manufacturing units, global coordination between them in terms of business processes, priorities, best practices, and instrumentation is essential. As such, the models in Figures 2 and 3 are appropriate, and their features apply fully to MS. Tight harmonization is particularly critical for multisite production of the same drug.

Tangible benefits should be associated with the symmetrical organization of PD and MS, which would enable simplified coordination and communication to better handle the typical push–pull dynamics between the two functions. It is easy to imagine and implement additional organizational tools that link PD and MS, including teams, committees, task forces, and a global project management function. These supporting elements are simpler to construct when the PD and MS organizations are compatible and structured the same way.

CONCLUSIONS

The dynamics of the biotechnology business imposes challenging demands on the individual sites and on the global multisite functions. Achieving a simultaneously high level of site autonomy while maintaining global coordination is a difficult task that requires proper organizational structure for PD and MS. However, these objectives are not mutually exclusive. The PD models outlined in Figures 2 and 3 provide a reasonable balance between the conflicting needs. These structures can incrementally evolve, reflecting the maturity of the entire organization. The proposed models also enable the smooth integration of newly acquired companies within the existing structures, without the negative effect of a complete reorganization or relocation of the new entities. Variations of the proposed models can be found in the biopharmaceutical industry today. In most real cases, however, the organizational structures are complicated by exceptions caused by historical or other reasons. Despite the model diversity, there is a clear trend towards globalization of the distributed PD function.

Missing the opportunity to strike a balance between site autonomy and global coordination entails a significant cost. If the PD groups are left disconnected, there will be a growing drift in direction, which will eventually result in inefficiencies, technology platform misalignments, and lost opportunities. The opposite is also true: overwhelming central control may stifle the creativity and innovation at individual sites. The organizational structure itself is an essential, but not sufficient, requirement for these models to work. Active management using the power of global reporting lines is necessary to promote common goals, priorities, learning, and standards.

Properly aligned global PD organizations have the following:

  • Fast corporatewide distribution of best practices and technology platforms across the PD network
  • Ability to globalize innovation sourced from different sites
  • Flexible resource allocation, rapid responses to changing priorities
  • Less internal competition
  • Focus on external competition
  • Improved efficiency through standardization of scale-down models, data- and knowledge- management systems, instrumentation, and business practices
  • Minimized redundancy and common priorities
  • Global PD management shifted to a lower level in the hierarchy.

In addition to the right organization of PD, a symmetrical structure of MS can provide additional benefits, making a step forward to the truly agile, ambidextrous enterprise capable of optimal management of short-term urgent projects, incremental improvement, and disruptive innovation (2, 3).

ACKNOWLEDGMENTS

The authors appreciate the open discussion with the management of several leading biopharmaceutical companies. The support of Dr. Eliana Clark of Genzyme is acknowledged with gratitude.

Konstantin Konstantinov* is vice-president of commercial process development and Steve Sofen is vice-president of project management, both at Genzyme.
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REFERENCES

1. K. Konstantinov et. al., presentation at the IBC Bioprocess International Conference (Anaheim, CA 2008).

2. M. Tushman and C. O'Reilly, Winning Through Innovation, (Harvard Business School Press, 1997).

3. C. Christensen, The Innovator's Dilemma, (Harper Business, 2000).


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