Quantification of clinical mAb solutions using Raman spectroscopy: Macroscopic vs microscopic analysis

Rayyad, Ayyoub; Makki, Alaa A.; Chourpa, Igor; Massot, Victor; Bonnier, Franck

doi:10.1016/j.talanta.2022.123692

Cited by 7 publications

(14 citation statements)

References 28 publications

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“…The peaks of trehalose were easily detected in the Raman spectrum of Avastin ® . Trehalose dihydrate is characterised by the peaks at 297 cm −1 , 354 cm −1 , 405 cm −1 , 438 cm −1 , 505 cm −1 , 540 cm −1 , 596 cm −1 , 706 cm −1 , 806 cm −1 , 844 cm −1 , 915 cm −1 , 1081 cm −1 , 1127 cm −1 , 1354 cm −1 and 1462 cm −1 ( Table 2 ) [ 17 , 25 , 31 ]. Several extra peaks were observed in the spectrum of Avastin ® that did not correspond to trehalose dihydrate.…”

Section: Resultsmentioning

confidence: 99%

“…It has been proposed as an alternative to HPLC for the qualitative and quantitative analysis of anticancer drugs and monoclonal antibodies, offering similar accuracy, precision and trueness to the respective analytical validation criteria measured using HPLC [ 16 ]. Raman spectroscopy could also serve as a fast, reliable, reproducible, non-invasive, non-destructive, cost-effective and environmentally friendly technique, requiring only a few seconds or minutes for sample preparation, in contrast to HPLC [ 17 ]. Thus, the applications of Raman spectroscopy in pharmaceutical and biomedical sciences are impressively increasing [ 18 , 19 , 20 , 21 , 22 ].…”

Section: Introductionmentioning

confidence: 99%

“…A specific application of Raman spectroscopy regarding biopharmaceutical analysis is the identification and quantification of monoclonal antibodies. Only a few studies have been published recently for the characterization and discrimination of monoclonal antibodies using Raman spectroscopy [ 23 , 24 , 25 , 26 , 27 , 28 ], and the quantification of monoclonal antibodies through Raman spectroscopy has been performed only in very few cases [ 17 , 25 , 29 ]. In the study of Rayyad et al, three monoclonal antibodies (bevacizumab, trastuzumab and atezolizumab) were quantified in a quartz cuvette and in perfusion bags using Raman spectroscopy [ 17 ].…”

Section: Introductionmentioning

confidence: 99%

“…Only a few studies have been published recently for the characterization and discrimination of monoclonal antibodies using Raman spectroscopy [ 23 , 24 , 25 , 26 , 27 , 28 ], and the quantification of monoclonal antibodies through Raman spectroscopy has been performed only in very few cases [ 17 , 25 , 29 ]. In the study of Rayyad et al, three monoclonal antibodies (bevacizumab, trastuzumab and atezolizumab) were quantified in a quartz cuvette and in perfusion bags using Raman spectroscopy [ 17 ]. The results of the analytical method developed for the quantification of cetuximab, rituximab, trastuzumab and bevacizumab via Raman spectroscopy using multivariate analysis in another study were found to be significantly affected by the excipients’ concentrations, leading to reliability and reproducibility concerns [ 25 ].…”

Section: Introductionmentioning

confidence: 99%

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Development of Analytical Method for the Quantitation of Monoclonal Antibodies Solutions via Raman Spectroscopy: The Case of Bevacizumab

Lykouras,

Papaspyridakou,

Makri

et al. 2024

Pharmaceuticals

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Personalized dosages of monoclonal antibodies are being used more regularly to treat various diseases, rendering their quantitation more essential than ever for the right dose administration to the patients. A promising alternative, which overcomes the obstacles of the well-established chromatographic techniques regarding the quantification of biopharmaceuticals, is Raman spectroscopy. This study aimed to develop and validate a novel analytical method for the quantitation of bevacizumab in solutions via Raman spectroscopy. For this purpose, a droplet of the solution was left to dry on a highly reflective carrier and a home-made apparatus was employed for rotation of the sample. Hence, each recorded Raman spectrum was the average of the signal acquired simultaneously from multiple points on a circular circumference. The method was validated, and the detection limit of the antibody was found to be 1.06 mg/mL. Bevacizumab was found to be highly distributed at the formed coffee ring of the dried droplet, though this was a function of solution concentration. Finally, Raman spectra at different distances on the coffee ring were obtained from the four quarters. The lowest bevacizumab detection limit was found at a distance of 75 μm from the external side of the coffee ring and it was determined to be equal to 0.53 mg/mL.

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Section: Resultsmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

See 2 more Smart Citations

Development of Analytical Method for the Quantitation of Monoclonal Antibodies Solutions via Raman Spectroscopy: The Case of Bevacizumab

Lykouras,

Papaspyridakou,

Makri

et al. 2024

Pharmaceuticals

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“…Interestingly, FTIR spectrometry has already been applied for the characterization of inhalable paclitaxel designed to treat lung cancer (38). The concept of applying Raman spectroscopy to the quality control of protein drugs (including bevacizumab and atezolizumab) through a perfusion bag wall appeared to be a rapid and precise technique applicable to centralized hospital workflow (39). FTIR and Raman spectroscopy are noninvasive and non-destructive techniques delivering molecular fingerprints and drug concentrations.…”

Section: Figure 3 Flow Cytometry Of Pd-l1 Staining (Cd274) Of Du-145 ...mentioning

confidence: 99%

Atezolizumab Retains Cellular Binding to Programmed Death Ligand 1 Following AerosolizationviaMesh Nebulizer

ZALESKIS¹,

TALAIKIS²,

Characiejus³

et al. 2023

Anticancer Res

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Background/Aim: Cytotoxic inhalable drugs were shown to be advantageous in treating malignancies of the respiratory tract. However, these drugs have not always presented a safe profile and were reported to induce local adverse events. Protein-based anticancer drugs, such as immune checkpoint and vascular endothelial growth factor inhibitors, do not induce tissue injury, nor do they exhibit vesicant properties upon direct contact with tissues. Protein drugs are susceptible to the heat and stress encountered during droplet generation for delivery by nebulization. The aim of this study was to investigate the capacity of atezolizumab, an antibody to programmed death ligand 1, to bind target cells after nebulization with a vibrating mesh (VM) nebulizer. Materials and Methods: We compared Fourier-transformed infrared (FTIR) and Raman spectra of native atezolizumab (60 mg/ml) and its nebulized form following 10-min nebulization in a piezoceramic VM nebulizer. The binding of atezolizumab to DU-145 prostate cancer cells was evaluated using competitive blocking of anti-CD274 staining. Results: Nebulization did not induce Raman or FTIR spectral modification nor did it affect the binding capacity of atezolizumab. Conversely, heat-inactivated atezolizumab lost its cell-binding capacity and did not reduce anti-CD274

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Fast quantitative determination of monoclonal antibody in infusion bags using protein A nano liquid chromatography

Andre,

Guillaume

2024

Separation Science Plus

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Staphylococcus aureus Protein A was immobilized on an in‐house made neutravidin poly (glycidyl methacrylate‐co‐ethylene dimethacrylate) capillary column with a 25 µm internal diameter, a length of 30 mm and a mass loadability of 60 ng. The immobilized quantity of protein A on the organic monolith was very low, in the pico mole range (1.80 pmol). This was of significance importance when working with less available or expensive purified enzyme. This capillary column was integrated into a nano liquid chromatographic system and used for the fast determination without dilution of the doses of therapeutic monoclonal antibodies (mAbs) in standardized infusion bags prepared in advance in a pharmacy department. This chromatographic method was linear in the studied concentration range with good precision and accuracy. Heat stressed studies indicated that the protein A affinity capillary column was able to monitor degraded mAbs. As well, the high specificity of this column to capture immunoglobulin G2 in cell culture supernatant was visualized. As the mAbs are produced through genetic engineering of animal cells this last result demonstrated that this novel protein A column could be used in the feature for rapid screening of immunoglobulin G concentration in cell culture.

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Quantification of clinical mAb solutions using Raman spectroscopy: Macroscopic vs microscopic analysis

Cited by 7 publications

References 28 publications

Development of Analytical Method for the Quantitation of Monoclonal Antibodies Solutions via Raman Spectroscopy: The Case of Bevacizumab

Development of Analytical Method for the Quantitation of Monoclonal Antibodies Solutions via Raman Spectroscopy: The Case of Bevacizumab

Atezolizumab Retains Cellular Binding to Programmed Death Ligand 1 Following AerosolizationviaMesh Nebulizer

Fast quantitative determination of monoclonal antibody in infusion bags using protein A nano liquid chromatography

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