Raman spectroscopy and multivariate analysis for the rapid discrimination between native-like and non-native states in freeze-dried protein formulations

European Journal of Pharmaceutics and Biopharmaceutics

Volumn 85, Issue 2, 2013, Pages 263-271

  Pieters, Sigrid ^a   Vander Heyden, Yvan ^a   Roger, Jean Michel ^b   D'Hondt, Matthias ^c   Hansen, Laurent ^c   Palagos, Bernard ^b   De Spiegeleer, Bart ^c   Remon, Jean Paul ^c   Vervaet, Chris ^c   De Beer, Thomas ^c  

^a VRIJE UNIVERSITEIT BRUSSEL   (Belgium)

^b CEMAGREF   (France)

^c GHENT UNIVERSITY   (Belgium)

Author keywords

Conformational state; Freeze drying; Lactate dehydrogenase; Multivariate analysis; PAT; Raman spectroscopy

Indexed keywords

AMIDE; EXCIPIENT; LACTATE DEHYDROGENASE;

AUTOMATION; CONFERENCE PAPER; CONFORMATIONAL TRANSITION; CONTROLLED STUDY; DISCRIMINANT ANALYSIS; EXPLORATORY RESEARCH; FREEZE DRYING; INFRARED SPECTROSCOPY; MULTIVARIATE ANALYSIS; PARTIAL LEAST SQUARES REGRESSION; PRINCIPAL COMPONENT ANALYSIS; PROTEIN SECONDARY STRUCTURE; PROTEIN SYNTHESIS; QUALITY CONTROL; RAMAN SPECTROMETRY; SIGNAL TRANSDUCTION;

CONFORMATIONAL STATE; FREEZE-DRYING; LACTATE DEHYDROGENASE; MULTIVARIATE ANALYSIS; PAT; RAMAN SPECTROSCOPY;

CHEMISTRY, PHARMACEUTICAL; EXCIPIENTS; FREEZE DRYING; L-LACTATE DEHYDROGENASE; LEAST-SQUARES ANALYSIS; MULTIVARIATE ANALYSIS; PRINCIPAL COMPONENT ANALYSIS; PROTEIN STRUCTURE, SECONDARY; PROTEINS; SPECTRUM ANALYSIS, RAMAN;

EID: 84885911476     PISSN: 09396411     EISSN: 18733441     Source Type: Journal    
DOI: 10.1016/j.ejpb.2013.03.035     Document Type: Conference Paper

References (44)

1. < www.fda.gov/downloads/Drugs/./Guidances/ucm070305.pdf > (accessed 26.10.12).
2. T. De Beer, A. Burggraeve, M. Fonteyne, L. Saerens, J.P. Remon, and C. Vervaet Near-infrared and Raman spectroscopy for the in-process monitoring of pharmaceutical production processes Int. J. Pharm. 417 2011 32 47
3. N.C. Dingari, G.L. Horowitz, J.W. Kang, R.R. Dasari, and I. Barman Raman spectroscopy provides a powerful diagnostic tool for accurate determination of albumin glycation PLoSOne 7 2012 1 11
4. B. Li, P.W. Ryan, B.H. Ray, K.J. Leister, N.M.S. Sirimuthu, and A.G. Ryder Rapid characterization and quality control of complex cell culture media solutions using Raman spectroscopy and chemometrics Biotechnol. Bioengin. 107 2010 290 301
5. J.J. Hill, E.Y. Shalaev, and G. Zografi Thermodynamic and dynamic factors involved in the stability of native protein structure in amorphous solids in relation to levels of hydration J. Pharm. Sci. 94 2005 1636 1667
6. J.C. Kasper, and W. Friess The freezing step in lyophilization: physico-chemical fundamentals, freezing methods and consequences on process performance and quality attributes of biopharmaceuticals Eur. J. Pharm. Biopharm. 78 2011 248 263
7. 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 1997 969 975
8. S.K. Niazi Handbook of Biogeneric Therapeutic Proteins: Regulatory, Manufacturing, Testing, and Patent Issues 2005 Informa Healthcare St Helier, Jersey pp. 265-289
9. S. Pieters, T. De Beer, J.C. Kasper, D. Boulpaep, O. Waszkiewicz, M. Goodarzi, C. Tistaert, W. Friess, J.P. Remon, C. Vervaet, and Y. Vander Heyden Near-infrared spectroscopy for in-line monitoring of protein unfolding and its interactions with lyoprotectants during freeze-drying Anal. Chem. 84 2012 947 955
10. A. Barth, and C. Zscherp What vibrations tell us about proteins Q. Rev. Biophys. 35 2002 369 430
11. S. Mangialardo, F. Piccirilli, A. Perucchi, P. Dore, and P. Postorino Raman analysis of insulin denaturation induced by high-pressure and thermal treatments J. Raman Spectrosc. 43 2012 692 700
12. A.A. Elkordy, R.T. Forbes, and B.W. Barry Study of protein conformational stability and integrity using calorimetry and FT-Raman spectroscopy correlated with enzymatic activity Eur. J. Pharm. Sci. 33 2008 177 190
13. R. Tuma Raman spectroscopy of proteins: from peptides to large assemblies J. Raman Spectrosc. 36 2005 307 319
14. R. Bro Multivariate calibration: what is in chemometrics for the analytical chemist? Anal. Chim. Acta 500 2003 185 194
15. A. Al-Hussein, and H. Gieseler The effect of mannitol crystallization in mannitol-sucrose systems on LDH stability during freeze-drying J. Pharm. Sci. 101 2012 2534 2544
16. www.sigmaaldrich.com/etc./medialib/docs/Sigma/Enzyme-Assay/I2500enz.Par. 0001.File.tmp/I2500enz.pdf.
17. B.G.M. Vandeginste, D.L. Massart, L.C.M. Buydens, S. De Jong, P.J. Lewi, and J. Smeyers-Verbeke Handbook of Chemometrics and Qualimetrics: Part B 1998 Elsevier Science Amsterdam pp. 87-160
18. R.A. Fisher The use of multiple measurement in taxonomic problems Ann. Eugen. 7 1936 179 188
19. M. Barker, and W. Rayens Partial least squares for discrimination J. Chemom. 17 2003 166 173
20. J.A. Westerhuis, H.C.J. Hoefsloot, S. Smit, D.J. Vis, A.K. Smilde, E.J.J. van Velzen, J.P.M. van Duijnhoven, and F.A. van Dorsten Assessment of PLSDA cross validation Metabolomics 4 2008 81 89
21. E.T.S. Skibsted, H.F.M. Boelens, J.A. Westerhuis, A.K. Smilde, N.W. Broad, D.R. Rees, and D.T. Witte Net analyte signal based statistical quality control Anal. Chem. 77 2005 7103 7114
22. C.L. Hansen, F. van den Berg, M.A. Rasmussen, S.B. Engelsen, and S. Holroyd Detecting variation in ultrafiltrated milk permeates - infrared spectroscopy signatures and external factor orthogonalization Chemom. Intell. Lab. Syst. 104 2010 243 248
23. R.C. Pinto, J. Trygg, and J. Gottfries Advantages of orthogonal inspection in chemometrics J. Chemom. 26 2011 231 235
24. J.C. Boulet, and J.M. Roger Pretreatments by means of orthogonal projections Chemom. Intell. Lab. Syst. 117 2012 61 69
25. J.T. Pelton, and L.R. McLean Spectroscopic methods for analysis of protein secondary structure Anal. Biochem. 277 2000 167 176
26. P.I. Haris, and F. Severcan FTIR spectroscopic characterization of protein structure in acqueous and non-acqueous media J. Mol. Catal. B: Enzymatic 7 1999 207 221
27. J. Kong, and S. Yu Fourier transform infrared spectroscopic analysis of protein secondary structures Acta Biochim. Biophys. Sinica 39 2007 549 559
28. A. Dong, S.J. Pestrelski, S.D. Allison, and J.F. Carpenter Infrared spectroscopic studies on lyophilization- and temperature-induced protein aggregation J. Pharm. Sci. 84 1995 415 424
29. K. Izutsu, N. Aoyagi, and S. Kojima Protection of protein secondary structure by saccharides of different molecular weights during freeze-drying Chem. Pharm. Bull. 52 2004 199 203
30. M. Jackson, and H.H. Mantsch The use and misuse of FTIR spectroscopy in the determination of protein structure Crit. Rev. Biochem. Mol. Biol. 30 1995 95 120
31. S.T.R. Walsh, R.P. Cheng, W.W. Wright, D.O.V. Alonso, V. Daggett, J.M. Vanderkooi, and W.F. Degrado The hydration of amides in helices: a comprehensive picture from molecular dynamics, IR, and NMR Protein Sci. 12 2003 520 531
32. S.D. Allison, T.D. Randolph, M.C. Manning, K. Middleton, A. Davis, and J.F. Carpenter Effects of drying methods and additives on structure and function of Actin: mechanisms of dehydration-induced damage and its inhibition Arch. Biochem. Biophys. 358 1998 171 181
33. A.M. Herrero Raman spectroscopy for monitoring protein structure in muscle food systems Crit. Rev. Food Sci. Nutr. 48 2008 512 523
34. K. Kjeldahl, and R. Bro Some common misunderstandings in chemometrics J. Chemom. 24 2010 558 564
35. A.M. Herrero, F. Jiménez-Colmenero, and P. Carmona Elucidation of structural changes in soy protein isolate upon heating by Raman spectroscopy Int. J. Food Sci. Technol. 44 2009 711 717
36. N.C. Maiti, M.M. Apetri, M.G. Zagorski, P.R. Carey, and V.E. Anderson Raman spectroscopic characterization of secondary structure in natively unfolded proteins: α-synuclein J. Am. Chem. Soc. 126 2004 2399 2408
37. A. Hédoux, L. Paccou, S. Achir, and Y. Guinet In situ monitoring of proteins during lyophilization using micro-Raman spectroscopy: a description of structural changes induced by dehydration J. Pharm. Sci. 101 2012 2316 2326
38. N.C. Maiti, M.M. Apetri, M.G. Zagorski, P.R. Carey, and V.E. Anderson Raman spectroscopic characterization of secondary structure in natively unfolded proteins: α-synuclein J. Am. Chem. Soc. 126 2004 2399 2408
39. R. Tantipolphan, T. Rades, and N.J. Medlicott Insights into the structure of proteins by vibrational spectroscopy Curr. Pharm. Anal. 4 2008 53 68
40. L.S. Taylor, and G. Zografi Sugar-polymer hydrogen bond interactions in lyophilized amorphous mixtures J. Pharm. Sci. 87 1998 1615 1621
41. T.W. Randolph Phase separation of excipients during lyophilization: effects on protein stability J. Pharm. Sci. 86 1997 1198 1203
42. S.D. Allison, B. Chang, T.W. Randolph, and J.F. Carpenter Hydrogen bonding between sugar and protein is responsible for inhibition of dehydration induced protein unfolding Arch. Biochem. Biophys. 365 1999 289 298
43. D. Ostrovskii, P. Jacobsson, B. Nystrom, O. Marstokk, and H.B.M. Kopperud Raman spectroscopic characterization of association and thermoreversible gelation in aqueous systems of poly(N-acetamidoacrylamide) Macromolecules 32 1999 5552 5560
44. M. Wang, M. Benford, N. Jing, G. Coté, and J. Kameoka Optofluidic device for ultra-sensitive detection of proteins using surface-enhanced Raman spectroscopy Microfluid Nanofluid 6 2009 411 417