Large-Scale Freezing of Biologics: Understanding Protein and Solute Concentration Changes in a Cryovessel—Part I - What really happens to protein and solute concentrations during bulk freezing

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Large-Scale Freezing of Biologics: Understanding Protein and Solute Concentration Changes in a Cryovessel—Part I
What really happens to protein and solute concentrations during bulk freezing at different rates.


BioPharm International
Volume 23, Issue 6

REFERENCES

1. Singh SK, Kolhe P, Wang W, Nema S. Large-scale freezing of biologics—a practitioner's review, part one: fundamental aspects. Bioprocess Int. 2009;7(10):32–44.

2. Singh SK, Kolhe P, Wang W, Nema S. Large-scale freezing of biologics—a practitioner's review. Part two: practical advice. Bioprocess Int. 2009;7(11):34–42.

3. Singh SK. Storage considerations as part of the formulation development program for biologics. Am Pharma Rev. 2007;10(3):26–33.

4. Bhatnagar BS, Bogner RH, Pikal MJ. Protein stability during freezing: separation of stresses and mechanisms of protein stabilization. Pharm Dev Technol. 2007;12(5):505–23.

5. Lashmar UT, Vanderburgh M, Little SJ. Bulk freeze–thawing of macromolecules effects of cryoconcentration on their formulation and stability. Bioprocess Int. 2007;5(6):44–54.

6. Tschoepe M, Schmidt R. Impact of freeze/thaw processing on monoclonal antibody stability. Bioprocess International Conference. Vienna, Switzerland. April 2008.

7. Webb SD, Webb JN, Hughes TG, Sesin DF, Kincaid AC. Freezing biopharmaceutical using common techniques and the magnitude of bulk scale freeze-concentration. Bioprocess Int. 2002;15(5):22–34.

8. Wisniewski R, Wu VL. Large-scale freezing and thawing of biopharmaceutical products. In: Avis KE, Wu VL, editors. Biotechnology and biopharmaceutical manufacturing, processing, and preservation. Interpharm Press, Buffalo Grove, IL. 1996:7–60.

9. Zippelius R. Untersuchung zum Enifrier- und Aufauverhalten Pharmazeutischer Humanproteinlosungen im Grossmasstab. (Investigation of Freezing and Thawing Process of Human Pharmaceutical Protein Solutions at Large Scale). PhD Thesis (in German), Ludwig-Maximilians University, Munich, 2002.

10. Kolhe P, Badkar A. Protein and Solute Distribution in Drug Substance Containers During Frozen Storage As Well As Post-Thawing: A Tool To Understand and Define Freezing-Thawing Parameters in Biotechnology Process Development Submitted 2009.

11. Maity H, Karkaria C, Davagnino J. Mapping of solution components, pH changes, protein stability and the elimination of protein precipitation during freeze-thawing of fibroblast growth factor 20. Int J Pharm. 2009;378(1-2):122-135.


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