Applying Raman spectroscopy to design of lyophilization cycles for protein formulation development

American Pharmaceutical Review

Volumn 12, Issue 6, 2009, Pages 44-53

  Krishnan, Sampath ^a   Cao, Wenjin ^a   Phillips, Joseph ^a  

^a AMGEN INC   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

AMIDE; AROMATIC AMIDE; EXCIPIENT; GLYCINE; MANNITOL; SUCROSE;

CRYSTALLIZATION; DRUG FORMULARY; DRUG FORMULATION; DRUG MANUFACTURE; ENVIRONMENTAL TEMPERATURE; EXCITATION; FREEZE DRYING; MICROENVIRONMENT; NEAR INFRARED SPECTROSCOPY; PROTEIN AGGREGATION; PROTEIN CONFORMATION; PROTEIN STABILITY; PROTEIN STRUCTURE; RAMAN SPECTROMETRY; REVIEW; SOLID STATE;

EID: 70350607884     PISSN: 10998012     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Review

References (22)

1. M. J. Pikal. Freeze drying of proteins. Part I. Process design. Biopharm 3: 18-25 (1990)
2. M.J. Pikal. Freeze drying of proteins. Part II. Formulation selection Biopharm 3: 26-30 (1990).
3. J.F. Carpenter, M.J. Pikal, B.S. Chang and T.W. Randolph Rational design of stable lyophilized protein formulations: some practical advice. Pharm Res., 14: 969-975 (1997)
4. A.I. Kim, M. J. Akers, and S. L. Nail. The physical state of mannitol after freeze-drying: Effects of mannitol concentration, freezing rate, and a noncrystallizing cosolute, 87(8): 931-935 (1998)
5. J.T. Pelton and L.R. McLean , Spectroscopic Methods for Analysis of Protein Secondary Structure, Analytical Biochemistry, 277: 167-176 (2000)
6. N.T. Yu. Comparison of protein structure in crystals, in lyophilized state and in solution by laser Raman scattering III. α-lactalbumin, J. Am. Chem. Soc. 96: 4664 -68 (1974)
7. H. Brunner and M. Holz. Raman studies on the basic pancreatic trypsin inhibitor, Biochim Biophys. Acta. 379: 408-417 (1975).
8. B. Prescott, V. Renugopalakrishnan, M.J.Glimcher, A. Bhushan, G.J. Thomas Jr. A Raman spectroscopic study of hen egg yolk phosvitin: Structures in solution and in the solid state. Biochemistry 25: 2792-2798 (1986)
9. S.U. Sane, R. Wong, C.C .Hsu. Raman spectroscopic characterization of drying-induced structural changes in a therapeutic antibody: correlating structural changes with long-term stability. J Pharm Sci, 93:1005-1018 (2004)
10. T.R. De Beer, P. Vercruysse, A. Burggraeve, T. Quinten, J. Ouyang, X. Zhang, C. Vervaet, J.P. Remon, W.R. Baeyens. In-line and real-time process monitoring of a freeze drying process using Raman and NIR spectroscopy as complementary process analytical technology (PAT) tools, J. Pharm Sci (2009)
11. X. Liao, R. Krishnamurthy, R. Suryanarayanan. Influence of the active pharmaceutical ingredient concentration on the physical state of mannitol - Implications in freeze-drying. Pharm Res 22: 1978-1985 (2005)
12. K.Izutsu, S. Kojima. Excipient crystallinity and its protein-structure- stabilizing effect during freeze-drying. J Pharm Pharmacol 54:1033-9) can alter the kinetics and extent of crystallization of mannitol. (2002)
13. X. Liao, R. Krishnamurthy, R. Suryanarayanan. Influence of processing conditions on the physical state of mannitol-implications in freeze-drying Pharm Res 24: 370-376 (2007)
14. R. K. Cavatur, and R. Suryanarayanan. Characterization of phase transitions during freeze-drying by in-situ X-ray powder diffractometry. Pharm. Dev. Technol. 3:579-586 (1998).
15. C. Telang, R. Suryanarayanan, and L. Yu. Crystallization of Dmannitol in binary mixtures with NaCl: Phase diagram and polymorphism. Pharm. Res. 20:1939-1945 (2003).
16. K. Poellaenen, A. Haekkinen, S.-P. Reinikainen, J. Rantanen, M. Karjalainen, M. Louhi-Kultanen, and L. Nystroem. IR spectroscopy together with multivariate data analysis as a process analytical tool for in-line monitoring of crystallization process and solid-state analysis of crystalline product. J. Pharmaceut. Biomed. 38:275-284 (2005).
17. W. Cao, C. Mao, W. Chen, H. Lin, S. Krishnan, and N. Cauchon. Differentiation and quantitative determination of surface and hydrate water in lyophilized mannitol using NIR spectroscopy. J. Pharm. Sci. 95:2077-2086 (2006).
18. S. N. C. Roberts, A. C.Williams, I. M. Grimsey, and S. W. Booth. Quantitative analysis of mannitol polymorphs. FT-Raman spectroscopy. J. Pharmaceut. Biomed. 28:1135-1147 (2002).
19. A. Burger, J. O. Henck, S. Hetz, J. M. Rollinger, A. A. Weissnicht, and H. Stottner. Energy/temperature diagram and compression behavior of the polymorphs of D-mannitol. J. Pharm. Sci. 89:457-468 (2000).
20. L. Yu, N. Milton, E. G. Groleau, D. S. Mishra, and R. E.Vansickle. Existence of a mannitol hydrate during freeze-drying and practical implications. J. Pharm. Sci. 88:196-198 (1999).
21. R. Vehring. Red-excitation dispersive Raman spectroscopy is a suitable technique for solid-state analysis of respirable pharmaceutical powders. Appl. Spectrosc. 59:286-292 (2005).
22. Y. Xie, W. Cao, S. Krishnan, H. Lin, and N. Cauchon. Characterization of mannitol polymorphic forms in lyophilized protein formulations using a multivariate curve resolution (MCR)-based Raman spectroscopic method. Pharm. Res. 25: 2292-2301 (2008).