Approaches for Early Developability Assessment of Proteins to Guide Quality by Design of Liquid Formulations

  • Bernardo Perez-Ramírez
  • Nicholas Guziewicz
  • Robert Simler
  • Alavattam Sreedhara
Part of the AAPS Advances in the Pharmaceutical Sciences Series book series (AAPS, volume 18)


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.


Solution behavior Preformulation Physical stability Stress studies Design of experiments (DOE) 


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Copyright information

© Springer Science+Business Media, LLC 2015

Authors and Affiliations

  • Bernardo Perez-Ramírez
    • 1
  • Nicholas Guziewicz
    • 2
  • Robert Simler
    • 3
  • Alavattam Sreedhara
    • 4
  1. 1.BioFormulations DevelopmentGlobal Biotherapeutics, Sanofi CorporationFraminghamUSA
  2. 2.Drug Product Process TechnologyAmgen Inc.Thousand OaksUSA
  3. 3.Formulation and Process DevelopmentBiogen Idec.CambridgeUSA
  4. 4.Late Stage Pharmaceutical DevelopmentGenentechSan FranciscoUSA

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