Design Space Development for Lyophilization Using DOE and Process Modeling - Develop a relevant design space without full factorial DoE. - BioPharm International

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Design Space Development for Lyophilization Using DOE and Process Modeling
Develop a relevant design space without full factorial DoE.


BioPharm International
Volume 23, Issue 9

REFERENCES

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10. Lim F, Martin-Moe, S, Sane SU. IBC USA Conferences Inc. A holistic approach to drug product process characterization and validation for a monoclonal antibody using QbD concepts. Process and Product Validation Event. Carlsbad, CA. 2010 Mar 1–2.

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12. Sane SU, Hsu CC. Considerations for successful lyophilization process scale-up, technology transfer and routine production. In: Jameel F, Hershenson S, editors. Formulation and process development strategies for manufacturing biopharmaceuticals. Hoboken, NJ: John Wiley & Sons, Inc.; 2010.

13. Sane SU, Hsu CC. A mathematical model for a large-scale freeze-drying process: a tool for process development & efficient production. Proceedings of 16th International Drying Symposium, Hyderabad, India. 2008; pp. 680–8.

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