Article (Scientific journals)
Moisture content determination in an antibody-drug conjugate freeze-dried medicine by near-infrared spectroscopy: a case study for release testing
Clavaud, Matthieu; Roggo, Yves; Dégardin, Klara et al.
2016In Journal of Pharmaceutical and Biomedical Analysis, 131, p. 380-390
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Keywords :
Antibody-drug conjugate; Freeze-dried medicine; Moisture content; Near-infrared spectroscopy; Partial least squares regression; Validation
Abstract :
[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 :
CIRM - Centre Interdisciplinaire de Recherche sur le Médicament - ULiège
Disciplines :
Pharmacy, pharmacology & toxicology
Author, co-author :
Clavaud, Matthieu ;  Université de Liège - ULiège > Form. doct. sc. biomed. & pharma. (paysage)
Roggo, Yves;  F. Hoffmann-La Roche Ltd - Roche > Complaints and Counterfeits
Dégardin, Klara;  F. Hoffmann-La Roche Ltd - Roche > Complaints and Counterfeits
Sacre, Pierre-Yves  ;  Université de Liège > Département de pharmacie > Chimie analytique
Hubert, Philippe  ;  Université de Liège > Département de pharmacie > Chimie analytique
Ziemons, Eric  ;  Université de Liège > Département de pharmacie > Département de pharmacie
Language :
English
Title :
Moisture content determination in an antibody-drug conjugate freeze-dried medicine by near-infrared spectroscopy: a case study for release testing
Publication date :
13 September 2016
Journal title :
Journal of Pharmaceutical and Biomedical Analysis
ISSN :
0731-7085
eISSN :
1873-264X
Publisher :
Elsevier Science, Oxford, United Kingdom
Volume :
131
Pages :
380-390
Peer reviewed :
Peer Reviewed verified by ORBi
Available on ORBi :
since 19 September 2016

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