Robustness testing in pharmaceutical freeze-drying: Inter-relation of process conditions and product quality attributes studied for a vaccine formulation

Pharmaceutical Development and Technology

Volumn 16, Issue 6, 2011, Pages 583-590

  Schneid, Stefan C ^a   Strtzel, Peter M ^a   Lettner, Patrick ^b   Gieseler, Henning ^a  

^a UNIVERSITY OF ERLANGEN NUREMBERG   (Germany)

^b IDT Biologika GmbH   (Germany)

Author keywords

Freeze drying; Lyophilization; Manometric temperature measurements; Process Analytical Technology; Process robustness; Quality by Design

Indexed keywords

BACTERIAL VACCINE;

ARTICLE; CELL COUNT; CONTROLLED STUDY; DIFFERENTIAL SCANNING CALORIMETRY; DRUG QUALITY; DRUG STABILITY; FREEZE DRYING; LIFE CELL COUNT; MICROSCOPY; POROSITY; PRIORITY JOURNAL; SCANNING ELECTRON MICROSCOPY; TEMPERATURE; VACCINE PRODUCTION; X RAY DIFFRACTION;

BACTERIAL VACCINES; CALORIMETRY, DIFFERENTIAL SCANNING; DRUG AND NARCOTIC CONTROL; DRUG DESIGN; DRUG STABILITY; DRUG STORAGE; FREEZE DRYING; MICROSCOPY; MICROSCOPY, ELECTRON, SCANNING; TEMPERATURE; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION; X-RAY DIFFRACTION;

EID: 80755181408     PISSN: 10837450     EISSN: 10979867     Source Type: Journal    
DOI: 10.3109/10837450.2011.581287     Document Type: Article

References (22)

1. Food and Drug Administration. (2002). Pharmaceutical cGMPs for the 21st century-A risk based approach.
2. Food and Drug Administration. (2004). Guidance for industry: PAT-A framework for innovative pharmaceutical development, manufacturing and quality assurance.
3. Yu LX. Pharmaceutical quality by design: product and process development, understanding, and control. Pharm Res 2008;25:781-791.
4. Gieseler H, Kramer T, Schneid S. Quality by design in freeze-drying: Cycle design and robustness testing in the laboratory using advanced process analytical technology. Pharm Technol 2008;10:88-95.
5. Schneid S, Meister E, Gieseler H. (2008). Design space in freeze drying: A robustness testing procedure in the laboratory to delineate the impact of product temperature variability on product quality attributes. Proceedings of the CPPR Freeze Drying of Pharmaceuticals and Biologicals Conference, Breckenridge, CO.
6. Lyophilization of Parenterals (7/93): Guide to Inspection of Lyophilization of Parenterals; U.S. Department of Health & Human Services, Food and Drug Administration, Inspections, Compliance, Enforcement, and Criminal Investigations. U.S. Government Printing Ofce: Washington, DC, 1993.
7. Overcashier DE, Patapof TW, Hsu CC. Lyophilization of protein formulations in vials: Investigation of the relationship between resistance to vapor fow during primary drying and small-scale product collapse. J Pharm Sci 1999;88:688-695. (Pubitemid 29325995)
8. Meister E, Gieseler H. Freeze-dry microscopy of protein/sugar mixtures: drying behavior, interpretation of collapse temperatures and a comparison to corresponding glass transition data. J Pharm Sci 2009;98:3072-3087.
9. Johnson RE, Oldroyd ME, Ahmed SS, Gieseler H, Lewis LM. Use of manometric temperature measurements (MTM) to characterize the freeze-drying behavior of amorphous protein formulations. J Pharm Sci 2010;99:2863-2873.
10. Schersch K, Betz O, Garidel P, Mühlau S, Bassarab S, Winter G. (2006). Efect of collapse during lyophilization and during storage at elevated temperatures on the stability of pharmaceutical protein lyophilizates. Proceedings of the CPPR Freeze-Drying of Pharmaceuticals and Biologicals, Garmisch-Partenkirchen, Germany, Oct. 3-6.
11. Wang DQ, Hey JM, Nail SL. Efect of collapse on the stability of freeze-dried recombinant factor VIII and a-amylase. J Pharm Sci 2004;93:1253-1263. (Pubitemid 38529698)
12. Lee JC, Timashef SN. Te stabilization of proteins by sucrose. J Biol Chem 1981;256:7193-7201.
13. Levine H, Slade L. Principles of cryostabilization technology from structure/property relationships of carbohydrate/water systems. A review. Cryo Lett 1988;9:21-63.
14. Lueckel B, Helk B, Bodmer D, Leuenberger H. Efects of formulation and process variables on the aggregation of freeze-dried interleukin-6 (IL-6) after lyophilization and on storage. Pharm Dev Technol 1998;3:337-346. (Pubitemid 28410361)
15. Passot S, Fonseca F, Barbouche N, Marin M, Alarcon-Lorca M, Rolland D, Rapaud M. Efect of product temperature during primary drying on the long-term stability of lyophilized proteins. Pharm Dev Technol 2007;12:543-553.
16. Pikal MJ. Te collapse temperature in freeze drying: Dependence on measurement methodology and rate of water removal from the glassy phase. Int J Pharm 1990;62:165-186. (Pubitemid 20261787)
17. Tang XC, Nail SL, Pikal MJ. Freeze-drying process design by manometric temperature measurement: Design of a smart freeze-dryer. Pharm Res 2005;22:685-700. (Pubitemid 40603267)
18. Tang X, Nail SL, Pikal MJ. Evaluation of manometric temperature measurement, a process analytical technology tool for freeze-drying: Part I, product temperature measurement. AAPS Pharm Sci Tech 2006;7:E14.
19. Adams GD, Ramsay JR. Optimizing the lyophilization cycle and the consequences of collapse on the pharmaceutical acceptability of Erwinia l-asparaginase. J Pharm Sci 1996;85:1301-1305. (Pubitemid 27014184)
20. Pikal MJ, Shah S, Roy ML, Putman R. Te secondary drying stage of freeze drying: Drying kinetics as a function of temperature and chamber pressure. Int J Pharm 1990;60:203-217. (Pubitemid 20179666)
21. Pikal MJ. Freeze drying. Encyclopedia Pharm Technol 2002:1299-1326.
22. Abdul-Fattah AM, Truong-Le V, Yee L, Pan E, Ao Y, Kalonia DS, Pikal MJ. Drying-induced variations in physico-chemical properties of amorphous pharmaceuticals and their impact on Stability II: Stability of a vaccine. Pharm Res 2007;24:715-727. (Pubitemid 46415554)