Understanding the discrimination and quantification of monoclonal antibodies preparations using Raman spectroscopy

Makki, Alaa A.; Massot, Victor; Byrne, Hugh J.; Respaud, Renaud; Bertrand, Dominique; Mohammed, Elhadi; Chourpa, Igor; Bonnier, Franck

doi:10.1016/j.jpba.2020.113734

Cited by 11 publications

(14 citation statements)

References 33 publications

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“…PLSR is the most widely used multivariate method to perform quantitative analysis of spectral data sets [43,55,56]. The first step is to construct the predictive model using a training set corresponding to 3/4 of the maps analysed for each SC sample.…”

Section: Data Analysis Using Partial Least Squares Regression (Plsr)mentioning

confidence: 99%

Estimating the Analytical Performance of Raman Spectroscopy for Quantification of Active Ingredients in Human Stratum Corneum

et al. 2022

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Confocal Raman microscopy (CRM) has become a versatile technique that can be applied routinely to monitor skin penetration of active molecules. In the present study, CRM coupled to multivariate analysis (namely PLSR—partial least squares regression) is used for the quantitative measurement of an active ingredient (AI) applied to isolated (ex vivo) human stratum corneum (SC), using systematically varied doses of resorcinol, as model compound, and the performance is quantified according to key figures of merit defined by regulatory bodies (ICH, FDA, and EMA). A methodology is thus demonstrated to establish the limit of detection (LOD), precision, accuracy, sensitivity (SEN), and selectivity (SEL) of the technique, and the performance according to these key figures of merit is compared to that of similar established methodologies, based on studies available in literature. First, principal components analysis (PCA) was used to examine the variability within the spectral data set collected. Second, ratios calculated from the area under the curve (AUC) of characteristic resorcinol and proteins/lipids bands (1400–1500 cm−1) were used to perform linear regression analysis of the Raman spectra. Third, cross-validated PLSR analysis was applied to perform quantitative analysis in the fingerprint region. The AUC results show clearly that the intensities of Raman features in the spectra collected are linearly correlated to resorcinol concentrations in the SC (R2 = 0.999) despite a heterogeneity in the distribution of the active molecule in the samples. The Root Mean Square Error of Cross-Validation (RMSECV) (0.017 mg resorcinol/mg SC), The Root Mean Square of Prediction (RMSEP) (0.015 mg resorcinol/mg SC), and R2 (0.971) demonstrate the reliability of the linear regression constructed, enabling accurate quantification of resorcinol. Furthermore, the results have enabled the determination, for the first time, of numerical criteria to estimate analytical performances of CRM, including LOD, precision using bias corrected mean square error prediction (BCMSEP), sensitivity, and selectivity, for quantification of the performance of the analytical technique. This is one step further towards demonstrating that Raman spectroscopy complies with international guidelines and to establishing the technique as a reference and approved tool for permeation studies.

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Section: Data Analysis Using Partial Least Squares Regression (Plsr)mentioning

confidence: 99%

Estimating the Analytical Performance of Raman Spectroscopy for Quantification of Active Ingredients in Human Stratum Corneum

et al. 2022

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“…Therefore, the main feature bands of proteins are observed at ~640 cm −1 (tyrosine), 755 cm −1 (tryptophan), 880 cm −1 (C-C backbone), 954 cm −1 (C-H stretching of α-helix structure), 1001 cm −1 (phenylalanine), 1237 cm −1 (amide III), 1335 cm −1 and 1445 cm −1 (CH2 deformation), 1551 cm −1 (amide II), and 1668 cm −1 (amide I). Notably, the main feature bands of sugar are observed at 880 cm −1 (C-O-C stretch) and 1350 cm −1 (NH2 twist), and the bands of glycosidic ring are observed at (830, 1000, 1450 cm −1 ) [17,19]. • Analysis filter: excipients Figure S1 reports the analysis on the filter retained during the filtration of trastuzumab.…”

Section: Spectral Characterization Of Commercial Mabs Solutions After...mentioning

confidence: 99%

A New Alternative Tool to Analyse Glycosylation in Monoclonal Antibodies Based on Drop-Coating Deposition Raman imaging: A Proof of Concept

et al. 2022

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Glycosylation is considered a critical quality attribute of therapeutic proteins as it affects their stability, bioactivity, and safety. Hence, the development of analytical methods able to characterize the composition and structure of glycoproteins is crucial. Existing methods are time consuming, expensive, and require significant sample preparation, which can alter the robustness of the analyses. In this context, we developed a fast, direct, and simple drop-coating deposition Raman imaging (DCDR) method combined with multivariate curve resolution alternating least square (MCR-ALS) to analyze glycosylation in monoclonal antibodies (mAbs). A database of hyperspectral Raman imaging data of glycoproteins was built, and the glycoproteins were characterized by LC-FLR-MS as a reference method to determine the composition in glycans and monosaccharides. The DCDR method was used and allowed the separation of excipient and protein by forming a “coffee ring”. MCR-ALS analysis was performed to visualize the distribution of the compounds in the drop and to extract the pure spectral components. Further, the strategy of SVD-truncation was used to select the number of components to resolve by MCR-ALS. Raman spectra were processed by support vector regression (SVR). SVR models showed good predictive performance in terms of RMSECV, R2CV.

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“…However, it is easy to relapse after these treatments, and the patients' survival rates are not significantly improved. Immunotherapy is useful for treating tumors, the mAbs bevacizumab, rituximab, and trastuzumab were already widely used against tumors outside the brain (75)(76)(77)(78)(79). But the current immunotherapy for medical glioma is costly and inefficient.…”

Section: The Application Of Phage Nanomaterials To Glioma Therapymentioning

confidence: 99%

Filamentous Bacteriophage—A Powerful Carrier for Glioma Therapy

et al. 2021

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Glioma is a life-threatening malignant tumor. Resistance to traditional treatments and tumor recurrence present major challenges in treating and managing this disease, consequently, new therapeutic strategies must be developed. Crossing the blood-brain barrier (BBB) is another challenge for most drug vectors and therapy medications. Filamentous bacteriophage can enter the brain across the BBB. Compared to traditional drug vectors, phage-based drugs offer thermodynamic stability, biocompatibility, homogeneity, high carrying capacity, self-assembly, scalability, and low toxicity. Tumor-targeting peptides from phage library and phages displaying targeting peptides are ideal drug delivery agents. This review summarized recent studies on phage-based glioma therapy and shed light on the developing therapeutics phage in the personalized treatment of glioma.

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Understanding the discrimination and quantification of monoclonal antibodies preparations using Raman spectroscopy

Cited by 11 publications

References 33 publications

Estimating the Analytical Performance of Raman Spectroscopy for Quantification of Active Ingredients in Human Stratum Corneum

Estimating the Analytical Performance of Raman Spectroscopy for Quantification of Active Ingredients in Human Stratum Corneum

A New Alternative Tool to Analyse Glycosylation in Monoclonal Antibodies Based on Drop-Coating Deposition Raman imaging: A Proof of Concept

Filamentous Bacteriophage—A Powerful Carrier for Glioma Therapy

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