[en] The use of Near-infrared spectroscopy (NIRS) as a fast and non-destructive technique was employed for moisture content (MC) determination in Antibody-drug conjugates (ADCs) in replacement to Karl Fischer (KF) method. The lab analysis of ADCs, high potent medicines, should be performed in conditions ensuring the operator’s safety and using secured analytical tools like NIRS. A NIRS method was first developed and validated in compliance with current guidelines. The novelty of this work first lies in the large number of samples prepared for a wide moisture calibration range of 0.51% to 4.01%. Then, the classical Partial Least Square (PLS) regression was used as chemometric tool for the computation of the model. Excellent predictive calibration results were shown. A coefficient of correlation (r) value of 0.99 was obtained. An intercept value of 0.02 and a slope of 0.99 were observed, while the root mean square error of calibration (RMSEC) and the root mean square error of prediction (RMSEP) were respectively 0.10% and 0.12%. In addition, instrumentation, model performances and robustness of the method were evaluated, demonstrating the validation results. Calibration transfer issue and impact of the number of samples were also evaluated. Consequently, a validation strategy was introduced as a basis for submission to the health authorities’ for release and stability activities in a cGMP environment in replacement of the KF method.
Research Center/Unit :
CIRM - Centre Interdisciplinaire de Recherche sur le Médicament - ULiège
scite shows how a scientific paper has been cited by providing the context of the citation, a classification describing whether it supports, mentions, or contrasts the cited claim, and a label indicating in which section the citation was made.
Bibliography
[1] Rohrer, T., Antibody drug conjugates potent weapons for the oncology arsenal. Chim. Oggi Chem. Today 27 (2009), 56–60.
[2] Cogdill, R.P., Drennen, J.K., Near-infrared spectroscopy. Brittain, H.G., (eds.) Spectroscopy of Pharmaceutical Solids, 2006, Taylor & Francis Group LLC, New York, 313–412.
[3] Roggo, Y., Chalus, P., Maurer, L., Lema-Martinez, C., Edmond, A., Jent, N., A review of near infrared spectroscopy and chemometrics in pharmaceutical technologies. J. Pharm. Biomed. Anal. 44 (2007), 683–700.
[4] De Bleye, C., Chavez, P.-F., Mantanus, J., Marini, R., Hubert, P., Rozet, E., Ziemons, E., Critical review of near-infrared spectroscopy methods validations in pharmaceutical applications. J. Pharm. Biomed. Anal. 69 (2012), 125–132.
[5] Food Drug Administration (FDA), Guideline for the Determination of Residual Moisture in Dried Biological Products. 2016, Rockville Pike, 1990.
[6] Airaksinen, S., Karjalainen, M., Shevchenko, A., Westermarck, S., Leppänen, E., Rantanen, J., Yliruusi, J., Role of water in the physical stability of solid dosage formulations. J. Pharm. Sci. 94 (2005), 2147–2165.
[7] Matsunaga, Y., Ohta, R., Bando, N., Yamada, H., Yuasa, H., Kanaya, Y., Effects of water content on physical and chemical stability of tablets containing an anticancer drug TAT-59. Chem. Pharm. Bull. 41 (1993), 720–724.
[8] Terakita, A., Hirokazu Matsunaga, H., Handa, T., The influence of water on the stability of lyophilized formulations with inositol and mannitol as excipients. Chem. Pharm. Bull. 57 (2009), 459–463.
[9] Szakonyi, G., Zelkó, R., The effect of water on the solid state characteristics of pharmaceutical excipients: molecular mechanisms, measurement techniques, and quality aspects of final dosage form. Int. J. Pharm. Investig. 2 (2012), 18–25.
[10] Daugherty, A.L., Mrsny, R.J., Formulation and delivery issues for monoclonal antibody therapeutics. Adv. Drug Deliv. Rev. 58 (2006), 686–706.
[12] United States Pharmacopeial Convention (USP38) General chapter <921> Water Determination Physical tests and determination, 2015.
[13] Kauppinen, A., Toiviainen, M., Lehtonen, M., Järvinen, K., Paaso, J., Juuti, M., Ketolainen, J., Validation of a multipoint near-infrared spectroscopy method for in-line moisture content analysis during freeze-drying. J. Pharm. Biomed. Anal. 95 (2014), 229–237.
[14] Food and Drug Administration (FDA), Guidance for industry PAT—a framework for innovative pharmaceutical development, manufacturing, and quality assurance, 2004.
[15] International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH), Validation of Analytical Procedures: Text and Methodology: Q2 (R1), 2005.
[16] Food Drug Administration (FDA), Analytical Procedures and Methods Validation for Drugs and Biologics. 2016, Guidance for industry, 2015.
[17] United States Department of Health and Human Services Food and Drug Administration, Development and Submission of Near Infrared Analytical Procedures – Guidance for Industry (DRAFT), in: Center for Drug Evaluation and Research (CDER) (Ed.), New Hampshire Avenue, 2015.
[18] United States Pharmacopeial Convention (USP38) General Chapter <1119> Near-Infrared Spectroscopy 2015.
[19] International Standard, Animal feedings stuffs, cereals and milled cereal products –guidelines for the application of near infrared spectrometry ISO 12099:2010(E), 2010.
[20] American Society for Testing and Materials(ASTM), E1655-05: Standard Practices for Infrared Multivariate Quantitative Analysis, 2012.
[21] European Medicines Agency, Guideline on the use of near infrared spectroscopy by the pharmaceutical industry and the data requirements for new submissions and variations EMEA/CHMP/CVMP/QWP/17760/2009 Rev2, 2014.
[23] European Pharmacopoeia 8th Edition 2016 (8.7), Chapter 5.21. Chemometric methods applied to analytical data, 2016.
[24] Japanese Industrial Standard, General rules for near-infrared spectrophotometric analysis, JIS K 0134, 2002.
[25] Japanese Pharmacopoeia, General Information – Physics and chemistry – Near Infrared Spectrometry – JP XVI, 2011.
[26] Hubert, P., Nguyen-Huu, J.-J., Boulanger, B., Chapuzet, E., Chiap, P., Cohen, N., Compagnon, P.-A., Dewe, W., Feinberg, M., Lallier, M., Laurentie, M., Mercier, N., Muzard, G., Nivet, C., Valat, L., Harmonization of strategies for the validation of quantitative analytical procedures. A SFSTP proposal—part I. J. Pharm. Biomed. Anal. 36 (2004), 579–586.
[27] Deutsches Institut für Normung, DIN 50 008 teil 1, Konstantklimate über wässrigen Lösungen, 1981.
[28] Rinnan, A., Van den Berg, F., Balling Engelsen, S., Review of the most common pre-processing techniques for near-infrared spectra. Trends Anal. Chem. 28 (2009), 1201–1222.
[29] Wold, S., Sjöström, M., Eriksson, L., PLS-regression: a basic tool of chemometrics. Chemom. Intell. Lab. 58 (2001), 109–130.
[30] Feinberg, M., Guide De Validation Des Methodes d'analyse. 2012, Lavoisier.
[32] Batten, G.D., Plant analysis using near infrared reflectance spectroscopy: the potential and the limitations. Aust. J. Exp. Agric. 38 (1998), 697–706.
[34] Bellon-Maurel, V., Fernandez-Ahumada, E., Palagos, B., Roger, J.-M., McBratney, A., Critical review of chemometric indicators commonly used for assessing the quality of the prediction of soil attributes by NIR spectroscopy. Trends Anal. Chem. 29 (2010), 1073–1081.
[35] Williams, P.C., Sobering, D.C., Davies, A.M.C., Williams, P.C., How do we do it: a Brief Summary of the Methods we use in Developing Near Infrared Calibrations—Near Infrared Spectroscopy: The Future Waves. NIR Publications 2 (1996), 185–188.
[36] Mika, V., Pozdisek, J., Tillmann, P., Nerusil, P., Buchgraber, K., Gruber, L., Development of NIR calibration valid for two different grass sample collections. Czech J. Anim. Sci. 48 (2003), 419–424.
[37] Roggo, Y., Duponchel, L., Ruckebusch, C., Huvenne, J.P., Statistical tests for comparison of quantitative and qualitative models developed with near infrared spectral data. J. Mol. Struct. 654 (2003), 253–262.
[38] Marini, R.D., Chiap, P., Boulanger, B., Rudaz, S., Rozet, E., Crommen, J., Hubert, P., LC method for the determination of R-timolol in S-timolol maleate: validation of its ability to quantify and uncertainty assessment. Talanta 68 (2006), 1166–1175.
[39] Trnka, H., Palou, A., Panouillot, P.E., Kauppinen, A., Toiviainen, M., Grohganz, H., Alcala, M., Juuti, M., Ketolainen, J., Rantanen, J., Near-infrared imaging for high-throughput screening of moisture induced changes in freeze-dried formulations. J. Pharm. Sci. 103 (2014), 2839–2846.
[40] United States Pharmacopeial Convention(USP38) General Chapter <621> Chromatography 2015.
Similar publications
Sorry the service is unavailable at the moment. Please try again later.
This website uses cookies to improve user experience. Read more
Save & Close
Accept all
Decline all
Show detailsHide details
Cookie declaration
About cookies
Strictly necessary
Performance
Strictly necessary cookies allow core website functionality such as user login and account management. The website cannot be used properly without strictly necessary cookies.
This cookie is used by Cookie-Script.com service to remember visitor cookie consent preferences. It is necessary for Cookie-Script.com cookie banner to work properly.
Performance cookies are used to see how visitors use the website, eg. analytics cookies. Those cookies cannot be used to directly identify a certain visitor.
Used to store the attribution information, the referrer initially used to visit the website
Cookies are small text files that are placed on your computer by websites that you visit. Websites use cookies to help users navigate efficiently and perform certain functions. Cookies that are required for the website to operate properly are allowed to be set without your permission. All other cookies need to be approved before they can be set in the browser.
You can change your consent to cookie usage at any time on our Privacy Policy page.
