Development of an analytical method for the determination of pimavanserin and its impurities applying analytical quality by design principles as a risk-based strategy

Radić, Irena; Runje, Mislav; Babić, Sandra

doi:10.1016/j.jpba.2021.114091

Cited by 13 publications

(5 citation statements)

References 22 publications

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“…The ATP was based on previous ELISA experimental results [ 20 ]. AQbD was used throughout ELISA development to ensure that the vaccines met all necessary quality requirements [ 21 , 22 ].…”

Section: Methodsmentioning

confidence: 99%

Development of an ELISA Assay for the Determination of SARS-CoV-2 Protein Subunit Vaccine Antigen Content

Han

An²,

Liu³

et al. 2022

Viruses

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The severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) protein subunit vaccine is one of the mainstream technology platforms for the development of COVID-19 vaccines, and most R&D units use the receptor-binding domain (RBD) or spike (S) protein as the main target antigen. The complexity of vaccine design, sequence, and expression systems makes it urgent to establish common antigen assays to facilitate vaccine development. In this study, we report the development of a double-antibody sandwich enzyme-linked immunosorbent assay (ELISA) to determine the antigen content of SARS-CoV-2 protein subunit vaccines based on the United States Pharmacopeia <1220> and ICH (international conference on harmonization) Q14 and Q2 (R2) requirements. A monoclonal antibody (mAb), 20D8, was identified as the detection antibody based on its high RBD binding activity (EC50 = 8.4 ng/mL), broad-spectrum anti-variant neutralizing activity (EC50: 2.7–9.8 ng/mL for pseudovirus and EC50: 9.6–127 ng/mL for authentic virus), good in vivo protection, and a recognized linear RBD epitope (369–379 aa). A porcine anti-RBD polyclonal antibody was selected as the coating antibody. Assay performance met the requirements of the analytical target profile with an accuracy and precision of ≥90% and adequate specificity. Within the specification range of 70–143%, the method capability index was >0.96; the misjudgment probability was <0.39%. The method successfully detected SARS-CoV-2 protein subunit vaccine antigens (RBD or S protein sequences in Alpha, Beta, Gamma, or Delta variants) obtained from five different manufacturers. Thus, we present a new robust, reliable, and general method for measuring the antigenic content of SARS-CoV-2 protein subunit vaccines. In addition to currently marketed and emergency vaccines, it is suitable for vaccines in development containing antigens derived from pre-Omicron mutant strains.

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“…The ATP was based on previous ELISA experimental results [ 20 ]. AQbD was used throughout ELISA development to ensure that the vaccines met all necessary quality requirements [ 21 , 22 ].…”

Section: Methodsmentioning

confidence: 99%

Development of an ELISA Assay for the Determination of SARS-CoV-2 Protein Subunit Vaccine Antigen Content

Han

An²,

Liu³

et al. 2022

Viruses

View full text Add to dashboard Cite

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“…A design of experiment-based robustness study was performed to determine the probability of risk or failure [29][30][31][32][33][34][35][36][37][38][39][40][41][42]. The critical analytical attributes (CAAs) are selected from the finalized method conditions, which significantly impact the separation of components, and verified against respective critical quality attributes (CQAs).…”

Section: Design Of Experiments Studymentioning

confidence: 99%

Development, stability‐indicating assessment, and evaluation of influential method conditions using a full factorial design for the determination of Nintedanib esylate‐related impurities

Yenda

Katari

Satheesh³

et al. 2023

J of Separation Science

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The design of an appropriate analytical method for assessing the quality of pharmaceuticals requires a deep understanding of science, and risk evaluation approaches are appreciated. The current study discusses how a related substance method was developed for Nintedanib esylate. The best possible separation between the critical peak pairs was achieved using an X-Select charged surface hybrid Phenyl Hexyl (150 × 4.6) mm, 3.5 μm column. A mixture of water, acetonitrile, and methanol in mobile phase-A (70:20:10) and mobile phase-B (20:70:10), with 0.1% trifluoroacetic acid and 0.05% formic acid in both eluents. The set flow rate, wavelength, and injection volumes were 1.0 ml/min, 285 nm, and 5 μl, respectively, with gradient elution. The method conditions were validated as per regulatory requirements and United States Pharmacopeia general chapter < 1225 >. The correlation coefficient for all impurities from the linearity experiment was found to be > 0.999. The % relative standard deviation from the precision experiments ranged from 0.4 to 3.6. The mean %recovery from the accuracy study ranged from 92.5 to 106.5. Demonstrated the power of the stabilityindicating method through degradation studies; the active drug component is more vulnerable to oxidation than other conditions. Final method conditions were further evaluated using a full-factorial design. The robust method conditions were identified using the graphical optimization from the design space.

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“…The optimization of a chromatographic condition could take a long time for the analyst, and could cause wasted solvents and samples. Thus, the association of automated LC scouting system and the use of DryLab ® software for the DoE parameters and to predict the optimized chromatographic conditions has become an interesting workflow for getting high chromatographic efficiency in short analysis time, which can overcome these drawbacks (Krisko et al, 2006;Racz et al, 2018;Guichard et al, 2019;Radic et al, 2020).…”

Section: Development Of the Chromatographic Conditionsmentioning

confidence: 99%

An LC-MS/MS method for quantitation of methylparaben, benzophenone, and pharmaceutical compounds from domestic wastewater

Barreiro

Florentino²,

Furlani³

et al. 2022

Front. Anal. Sci.

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An analytical method was developed to quantify a mixture of acetaminophen, metoprolol, methylparaben, carbamazepine, naproxen, estrone, estradiol, diclofenac, benzophenone, ibuprofen, progesterone, and mefenamic acid from domestic wastewater samples. To match fast and efficient chromatographic separation for different classes of compounds, an automated scouting liquid chromatographic system was associated with the experimental design produced by the DryLab® software. HLB cartridges were used to extract the analytes from the sample matrix, which was followed by detection and quantitation by liquid chromatography-tandem mass spectrometry (LC-MS/MS). The lowest detection limits were found for acetaminophen and carbamazepine (0.625 pg L−1) and metoprolol (0.4 pg L−1).

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Development of an analytical method for the determination of pimavanserin and its impurities applying analytical quality by design principles as a risk-based strategy

Cited by 13 publications

References 22 publications

Development of an ELISA Assay for the Determination of SARS-CoV-2 Protein Subunit Vaccine Antigen Content

Development of an ELISA Assay for the Determination of SARS-CoV-2 Protein Subunit Vaccine Antigen Content

Development, stability‐indicating assessment, and evaluation of influential method conditions using a full factorial design for the determination of Nintedanib esylate‐related impurities

An LC-MS/MS method for quantitation of methylparaben, benzophenone, and pharmaceutical compounds from domestic wastewater

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