Journal of Innovative Optical Health Sciences, 2015, 8 (6): 1550034, Published Online: Jan. 10, 2019  

Application of near infrared spectroscopy in monitoring the moisture content in freeze-drying process of human coagulation factor VIII

Author Affiliations
1 School of Pharmaceutical Sciences and National Glycoengineering Research Center Shandong University, Wenhuaxi Road 44, Jinan 250012, P. R. China
2 Beijing Kaiyuan Shengshi Science and Technology Development Co., Ltd. Wenhuaxi Road 44, Jinan 250012, P. R. China
3 School of Pharmacy, Shenyang Pharmaceutical University Shenyang 110016, P. R. China
Abstract
As an important process analysis tool, near infrared spectroscopy (NIRS) has been widely used in process monitoring. In the present work, the feasibility of NIRS for monitoring the moisture content of human coagulation factor VIII (FVIII) in freeze-drying process was investigated. A partial least squares regression (PLS-R) model for moisture content determination was built with 88 samples. Different pre-processing methods were explored, and the best method found was standard normal variate (SNV) transformation combined with 1st derivation with Savitzky– Golay (SG) 15 point smoothing. Then, four different variable selection methods, including uninformative variable elimination (UVE), interval partial least squares regression (iPLS), competitive adaptive reweighted sampling (CARS) and manual method, were compared for eliminating irrelevant variables, and iPLS was chosen as the best variable selection method. The correlation coe±cient (R), correlation coe±cient of calibration set (Rcal), correlation coe±cient of validation set (Rval), root mean square errors of cross-validation (RMSECV) and root mean square errors of prediction (RMSEP) of PLS model were 0.9284, 0.9463, 0.8890, 0.4986% and 0.4514%, respectively. The results showed that the model for moisture content determination has a wide range, good linearity, accuracy and precision. The developed approach was demonstrated to be a potential for monitoring the moisture content of FVIII in freeze-drying process.
References

[1] P. J. Fay, “Factor VIII structure and function," Int. J. Hematol. 83, 103–108 (2006)

[2] G. A. Vehar, B. Keyt, D. Eaton, H. Rodriguez, D. P. O'Brien, F. Rotblat, H. Oppermann, R. Keck, W. I. Wood, R. N. Harkins, E. G. Tuddenham, R. M. Lawn, D. J. Capon, “Structure of human factor VIII," Nature 312, 337–342 (1984)

[3] P. J. Fay, “Activation of factor VIII and mechanisms of cofactor action," Blood Rev. 18, 1–15 (2004)

[4] P. M. Mannucci, M. E. Mancuso, E. Santagostino, “How we choose factor VIII to treat hemophilia," Blood 119, 4108–4114 (2012)

[5] T. Burnouf, “Modern plasma fractionation," Transfus. Med. Rev. 21, 101–117 (2007)

[6] M. J. Maltesen, M. van de Weert, “Drying methods for protein pharmaceuticals," Drug Discov. Today Technol. 5, e81–e88 (2008)

[7] A. Kauppinen, M. Toiviainen, O. Korhonen, J. Aaltonen, K. Jarvinen, J. Paaso, M. Juuti, J. Ketolainen, “In-line multipoint near-infrared spectroscopy for moisture content quantiˉcation during freeze-drying," Anal. Chem. 85, 2377–2384 (2013)

[8] A. Kauppinen, M. Toiviainen, M. Lehtonen, K. Jarvinen, J. Paaso, M. Juuti, J. Ketolainen, “Validation of a multipoint near-infrared spectroscopy method for in-line moisture content analysis during freeze-drying," J. Pharm. Biomed. Anal. 95, 229–237 (2014)

[9] Committee SP, Pharmacopoeia of the People's Republic of China, People's Medical Publishing House, Beijing (2010)

[10] M. J. Pikal, “Freeze-drying of proteins: Process, formulation and stability," ACS Symp. Ser. 567, 120–133 (1994)

[11] L. L. Chang, D. Shepherd, J. Sun, X. C. Tang, M. J. Pikal, “Effect of sorbitol and residual moisture on the stability of lyophilized antibodies: Implications for the mechanism of protein stabilization in the solid state," J. Pharm. Sci. 94, 1445–1455 (2005)

[12] C. A. De Caro, A. Aichert, C. M. Walter, “Efficient, precise and fast water determination by the Karl Fischer titration," Food Control 12, 431–436 (2001)

[13] M. M. Pojic, J. S. Mastilovic, “Near infrared spectroscopy- advanced analytical tool in wheat breeding, trade, and processing," Food Bioprocess Technol. 6, 330–352 (2013)

[14] S. A. Haughey, S. F. Graham, E. Cancouet, C. T. Elliott, “The application of near-infrared re°ectance spectroscopy (NIRS) to detect melamine adulteration of soya bean meal," Food Chem. 136, 1557– 1561 (2013)

[15] M. Blanco, S. Maspoch, I. Villarroya, X. Peralta, J. M. Gonzalez, J. Torres, “Geographical origin classiˉcation of petroleum crudes from near-infrared spectra of bitumens," Appl. Spectrosc. 55, 834–839 (2001)

[16] H. C. Zang, J. F. Wang, L. Li, H. Zhang, W. Jiang, F. S. Wang, “Application of near-infrared spectroscopy combined with multivariate analysis in monitoring of crude heparin puriˉcation process," Spectrochim. Acta A Mol. Biomol. Spectrosc. 109, 8–13 (2013)

[17] W. Momose, K. Imai, S. Yokota, E. Yonemochi, K. Terada, “Process analytical technology applied for end-point detection of pharmaceutical blending by combining two calibration-free methods: Simultaneously monitoring specific near-infrared peak intensity and moving block standard deviation," Powder Technol. 210, 122–131 (2011)

[18] R. Kona, H. Qu, R. Mattes, B. Jancsik, R. M. Fahmy, S. W. Hoag, “Application of in-line near infrared spectroscopy and multivariate batch modeling for process monitoring in °uid bed granulation," Int. J. Pharm. 452, 63–72 (2013)

[19] A. Peinado, J. Hammond, A. Scott, “Development, validation and transfer of a near infrared method to determine in-line the end point of a fluidised drying process for commercial production batches of an approved oral solid dose pharmaceutical product," J. Pharm. Biomed. Anal. 54, 13–20 (2011)

[20] J. D. Perez-Ramos, W. P. Findlay, G. Peck, K. R. Morris, “Quantitative analysis of film coating in a pan coater based on in-line sensor measurements," AAPS Pharm. Sci. Tech 6, E127–136 (2005)

[21] P. Wang, H. Zhang, H. Yang, L. Nie, H. Zang, “Rapid determination of major bioactive iso- flavonoid compounds during the extraction process of kudzu (Pueraria lobata) by near-infrared transmission spectroscopy," Spectrochim. Acta. A Mol. Biomol. Spectrosc. 137, 1403–1408 (2015)

[22] J. Luypaert, D. L. Massart, Y. Vander Heyden, “Near-infrared spectroscopy applications in pharmaceutical analysis," Talanta 72, 865–883 (2007)

[23] M. Brulls, S. Folestad, A. Sparen, A. Rasmuson, “In-situ near-infrared spectroscopy monitoring of the lyophilization process," Pharm. Res. 20, 494– 499 (2003)

[24] V. Centner, D. L. Massart, O. E. de Noord, S. de Jong, B. M. Vandeginste, C. Sterna, “Elimination of uninformative variables for multivariate calibration," Anal. Chem. 68, 3851–3858 (1996)

[25] L. Norgaard, A. Saudland, J. Wagner, J. P. Nielsen, L. Munck, S. B. Engelsen, “Interval partial leastsquares regression (iPLS): A comparative chemometric study with an example from near-infrared spectroscopy," Appl. Spectrosc. 54, 413–419 (2000)

[26] H. D. Li, Y. Z. Liang, Q. S. Xu, D. S. Cao, “Key wavelengths screening using competitive adaptive reweighted sampling method for multivariate calibration," Anal. Chim. Acta. 648, 77–84 (2009)

[27] R. K. H. Galvao, M. C. U. Araujo, G. E. Jose, M. J. C. Pontes, E. C. Silva, T. C. B. Saldanha, “A method for calibration and validation subset partitioning," Talanta 67, 736–740 (2005)

[28] R. A. Davis, A. J. Charlton, S. Oehlschlager, J. C. Wilson, “Novel feature selection method for genetic programming using metabolomic 1H NMR data," Chemometr. Intell. Lab. 81, 50–59 (2006)

[29] Z. G. Song, P. X. Ling, H. C. Zang, L. Li, J. F. Wang, Y. Jin, H. R. Shao, X. Q. Zhu, F. Liu, F. S. Wang, “Development, validation and influence factor analysis of a near-infrared method for the molecular weight determination of xanthan gum," Carbohyd. Polym. 115, 582–588 (2015).

Fei Wang, Wei Jiang, Can Li, Hui Zhang, Lei Nie, Lian Li, Pei Wang, Hengchang Zang. Application of near infrared spectroscopy in monitoring the moisture content in freeze-drying process of human coagulation factor VIII[J]. Journal of Innovative Optical Health Sciences, 2015, 8(6): 1550034.

关于本站 Cookie 的使用提示

中国光学期刊网使用基于 cookie 的技术来更好地为您提供各项服务,点击此处了解我们的隐私策略。 如您需继续使用本网站,请您授权我们使用本地 cookie 来保存部分信息。
全站搜索
您最值得信赖的光电行业旗舰网络服务平台!