Abstract
A systematic work process has been defined that strengthens the critical interface between discovery research and formulation development for the early identification of suitable protein candidates to be moved into formulation development and assess their developmentability/manufacturability potential. This predevelopment risk-based approach is essential for (i) understanding the solution behavior of therapeutic proteins, (ii) identifying preliminary critical quality attributes, (iii) optimizing liquid formulations earlier, and (iv) aligning with the quality by design requirements directed by industry guidelines, namely, ICH Q8(R2), Q9, and Q10.
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Perez-RamÃrez, B., Guziewicz, N., Simler, R., Sreedhara, A. (2015). Approaches for Early Developability Assessment of Proteins to Guide Quality by Design of Liquid Formulations. In: Jameel, F., Hershenson, S., Khan, M., Martin-Moe, S. (eds) Quality by Design for Biopharmaceutical Drug Product Development. AAPS Advances in the Pharmaceutical Sciences Series, vol 18. Springer, New York, NY. https://doi.org/10.1007/978-1-4939-2316-8_6
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