Successful lyophilization development of protein therapeutics

American Pharmaceutical Review

Volumn 12, Issue 1, 2009, Pages

  Blue, Jeffrey ^a,b   Yoder, Heidi ^a  

^a LEHIGH UNIVERSITY   (United States)

^b SAINT JOSEPH S UNIVERSITY   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

MONOCLONAL ANTIBODY; MONOCLONAL ANTIBODY 1; MONOCLONAL ANTIBODY 2; UNCLASSIFIED DRUG;

DRUG DISTRIBUTION; DRUG FORMULATION; DRUG MANUFACTURE; DRUG STABILITY; DRUG STORAGE; FREEZE DRYING; FREEZING; HOME CARE; LIQUID; MOISTURE; PRESSURE; ROOM TEMPERATURE; SHORT SURVEY; TEMPERATURE;

EID: 62549157104     PISSN: 10998012     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Short Survey

References (13)

1. Carpenter, JF, Pikal, MJ, Chang, BS, and Randolph, TW. Rational Design of Stable Lyophilized Protein Formulations: Some Practical Advice. Pharm. Res. Vol. 14: 969 - 975 (1997).
2. Tang, XC, and Pikal, MJ. Design of Freeze-Drying Processes for Pharmaceuticals: Practical Advice. Pharm. Res. Vol. 2: 191 - 200 (2004)
3. Harris, JH, Shire, SJ, and Winter C. Commercial Manufacturing Scale Formulation and Analytical Characterization of Therapeutic Recombinant Antibodies. Drug Dev. Res. Vol. 61: 137 - 154 (2004).
4. Sarciaux, JM, Mansour, S, Hageman, MJ, and Nail, SL. Effects of Buffer Conditions on Aggregation of Bovine IgG during Freeze-Drying. J. Pharm. Sci. Vol. 12: 1354 - 1361 (1999).
5. Shire, SJ, Shahrokh, Z, Liu, J. Challenges in the Development of High Protein Concentration Formulations. J. Pharm. Sci. Vol.6: 1390 - 1402 (2004).
6. Chang, BS, Kendrick, BS, and Carpenter, JF. Surface-Induced Denaturation of Proteins during Freezing and Its Inhibition by Surfactants. J. Pharm. Sci. Vol 12: 1325 - 1330 (1996).
7. Cao, E, Chen, Y, Cui, Z, Foster, PR. Effect of Freezing and Thawing Rates on Denaturation of Proteins in Aqueous Solutions. Biotechnol. Bioeng. Vol. 6: 685 - 690 (2003).
8. Privalov, PL. Cold Denaturation of Proteins. Crit. Rev. Biochem. Mol. Biol. Vol. 25: 218 - 305 (1990).
9. Heller, MC, Carpenter, JF, Randolph, TW. Protein Formulation and Lyophilization Cycle Design: Prevention of Damage Due to Freeze- Concentration Induced Phase Separation. Biotechnol. Bioeng. Vol. 63: 166 - 174 (1999).
10. Mackenzie, AP. Basic Principles of Freeze-Drying for Pharmaceuticals. Bull. Parenter. Drug Assoc. Vol. 20: 101 - 130 (1966).
11. Searles, JA, Carpenter, JF, Randolph, TW. Annealing to Optimize the Primary Drying Rate, Reduce Freezing-Induced Drying Rate Heterogeneity, and Determine Tg' in Pharmaceutical Lyophilization. J. Pharm. Sci. Vol. 7: 872 - 887 (2001).
12. Ma, X, Wang, DQ, Bouffard, R, and MacKenzie, A. Characterization of Murine Monoclonal Antibody to Tumor Necrosis Factor (TNF-MAb) Formulation for Freeze-Drying Cycle Development. Pharm. Res. Vol. 2: 196 - 202 (2001).
13. Nail, SL, and Gatlin, LA. Freeze-drying: Principles and Practice. In: Pharmaceutical Dosage Forms: Parenteral Medications Vol. 2 (K.E. Avis, H.A. Lieberman, and L. Lachman, Eds) Marcel Dekker, New York. 163 - 233 (1993).