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,
p.bolon@eurogentec.com
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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