Sponsor-CMO Conflict Management for Clinical-Phase Biologics - The authors present the CMO's perspective on various potential sources of sponsor-CMO conflicts. - BioPharm International

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Sponsor-CMO Conflict Management for Clinical-Phase Biologics
The authors present the CMO's perspective on various potential sources of sponsor-CMO conflicts.


BioPharm International Supplements
Volume 24, Issue 3, pp. s4-s8

Conclusion

Jointly building and documenting various tools before initiating a project will ensure that both parties are on the same page with respect to project goals. The use of a structured contractual framework based on a MSA, PAs, and QA provides the necessary flexibility to move process development and GMP manufacturing forward in a scientifically sound manner and under clear contractual terms in ways that a single technical agreement cannot. The reduced flexibility of a technical agreement can be a source of conflict. Although the MSA, PA, and QA are important conflict-resolution tools, successful projects benefit from collaboration, transparency with regard to capabilities and expectations, expertise, project status, and identification of specific subsequent milestones.

Acknowledgments

We would like to acknowledge Ingrid Dheur, biologics director, and Florence Xhonneux, business development manager for their insightful comments.

PIERRE DOUETTE, PHD, is GMP quality control manager, PHILIPPE LEDENT, PHD, is process transfer and development manager, SOPHIE LEPAGE, PHD, is project manager, and PASCAL BOLON*, PHD, is sales and marketing manager, all at Eurogentec, Rue du Bois Saint-Jean 5, B-4102, Seraing, Belgium, +32 4 366 61 16,

References

1. P.M. Seymour, H.L. Levine, and S.D. Jones, supp. to BioProcess Int. (Sept. 2006).

2. D. Moyer, BioPharm Int. 22 (4), (2009).

3. L. Choi and S. Rudge, BioProcess Int., (Aug. 2010).

4. S. Portman, BioProcess Int. (July 2008).

5. L.D. Bentley and M. Levin, Contract Pharma, 10 (2005).


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