Stability Assessment of FDA Approved Ramucirumab Monoclonal Antibody; Validated SE‐HPLC Method for Degradation Pattern Evaluation

2021 ◽  
Author(s):  
Sara H. Abdelghaffar ◽  
Maha A. Hegazy ◽  
Basma M. Eltanany
Keyword(s):  
Monoclonal Antibody ◽  
Hplc Method ◽  
Stability Assessment ◽  
Degradation Pattern

Development of a monoclonal antibody-based ELISA for the detection of the novel insecticide cyantraniliprole

RSC Advances ◽  
2015 ◽  
Vol 5 (45) ◽  
pp. 35874-35881 ◽  
Author(s):  
Rui Zhang ◽  
Kechang Liu ◽  
Yongliang Cui ◽  
Wei Zhang ◽  
Lishan He ◽  
...  
Keyword(s):  
Monoclonal Antibody ◽  
Hplc Method ◽  
The Novel ◽  
Highly Sensitive

A highly sensitive and selective immunoassay was developed for the analysis of cyantraniliprole. The concentrations of cyantraniliprole residues in pakchoi samples determined by ELISA agreed with those by the HPLC method.

Measurement of high protein concentrations by optical rotation: a case study for monitoring of monoclonal antibody drug downstream processes

2021 ◽  
Vol 22 ◽  
Author(s):  
Hidenori Inaba ◽  
Kosuke Wakabayashi ◽  
Ikuo Tsujimoto ◽  
Noriko Yoshimoto ◽  
Shuichi Yamamoto
Keyword(s):  
Monoclonal Antibody ◽  
Membrane Filtration ◽  
Optical Rotation ◽  
Protein A ◽  
Small Variation ◽  
Hplc Method ◽  
Unit Operations ◽  
Downstream Processes ◽  
Good Agreement

Background: Recent advancements in cell engineering and bioreactor engineering have enabled high monoclonal antibody (mAb) concentrations in harvested solutions for the downstream process (DSP). Methods: As many unit operations such as capture chromatography, polish chromatography, membrane filtration, virus inactivation, virus filtration, and concentration by ultrafiltration are involved in DSP, it is crucial to monitor the process carefully in order to perform reliable and stable DSP operations. One of the most important signals (process parameter) to be monitored is the protein concentration CP. Although various methods are available, most of them are not suited for measuring high CP. In this paper, we have developed a method for measuring very high CP by optical rotation (OR). Result: Linear correlations were confirmed between OR and CP in the range CP = 0 to 80 g/L for mAbs with high repeatability and small variation coefficients. This method was applied to the monitoring of CP in the opaque (colored) solution during the cell culture. The CP by OR was in good agreement with those by the standard Protein A HPLC method. Conclusion: Monitoring of high CP by OR is expected to be an efficient process analytical tool (PAT) for DSP.

Determination of cyclosporine in plasma: specific radioimmunoassay with a monoclonal antibody and liquid chromatography compared.

1989 ◽  
Vol 35 (4) ◽  
pp. 608-611 ◽  
Author(s):  
L Vernillet ◽  
H P Keller ◽  
J F Le Bigot ◽  
H Humbert
Keyword(s):  
Monoclonal Antibody ◽  
Bone Marrow ◽  
Liquid Chromatography ◽  
Drug Monitoring ◽  
Limit Of Detection ◽  
Parent Drug ◽  
Hplc Method ◽  
Monitoring Period ◽  
Specific Radioimmunoassay

Abstract A radioimmunoassay of cyclosporine (Sandimmune) involving use of a mouse monoclonal antibody was tested to monitor specifically the parent drug in plasma. The cyclosporine concentrations obtained by RIA were compared with those obtained by the HPLC method. For the RIA method, the within- and between-assay CVs are less than 6%, the limit of detection is about 10 micrograms/L for a 50-microL sample of plasma. For the HPLC method, the within- and between-assay CVs are less than 20%, the limit of detection is about 15 micrograms/L for a 1-mL sample of plasma. The concentrations by RIA correlated well with those by HPLC in samples from patients receiving bone-marrow (n = 39), heart (n = 52), or liver (n = 51) transplants. In all indications, the ratio of values by RIA to those by HPLC for these samples remained stable and close to 1 during the drug-monitoring period, i.e., for up to 202 days. Therefore, the specific RIA can be used instead of HPLC to measure the parent drug in plasma.

scholarly journals Immunoassays for the Rapid Detection of Gentamicin and Micronomicin in Swine Muscle

2010 ◽  
Vol 93 (1) ◽  
pp. 335-342 ◽  
Author(s):  
Yiqiang Chen ◽  
Xiangmei Li ◽  
Lidong He ◽  
Shuheng Tang ◽  
Xilong Xiao
Keyword(s):  
Monoclonal Antibody ◽  
Detection Limit ◽  
Rapid Detection ◽  
Cross Reactivity ◽  
Hplc Method ◽  
Rapid Screening ◽  
Test Elisa ◽  
Inhibition Concentration ◽  
Strip Test ◽  
Phosphate Buffered Saline

Abstract A monoclonal antibody (mAb)-based ELISA and strip test for gentamicin (GEN) and its analogue micronomicin (MIN), are reported in this study. The conjugate gentamicin-glutaraldehyde-bovine serum albumin (GEN-GDA-BSA) was used as an immunogen. The produced anti-GEN mAB exhibited high cross-reactivity with micronomicin (MIN; 131.2) and slight or negligible cross-reactivity with other aminoglycosides. Based on this mAB, an ELISA and a strip test for GEN and MIN were developed and evaluated. The ELISA showed a 50 inhibition concentration (IC50) of 0.75 ng/mL for GEN and 0.58 ng/mL for MIN. For GEN, the average recoveries at 25200 µg/kg ranged from 73 to 91, with intraday CVs of 916 and interday CVs of 815. For MIN, the average recoveries ranged from 108 to 131, with intraday CVs of 1016 and interday CVs of 815. In contrast, the strip test for GEN or MIN had a detection limit of 5 ng/mL in phosphate-buffered saline and 50 µg/kg in muscle (n = 24), and the results could be judged within 10 min. The detection results of incurred samples analyzed by the strip test, ELISA, and HPLC indicated that the two immunoassays correlated well with the HPLC method and could be used as convenient tools for the rapid screening of GEN and MIN residues in swine muscle.

scholarly journals Bioanalysis of doxorubicin aglycone metabolites in human plasma samples–implications for doxorubicin drug monitoring

2020 ◽  
Vol 10 (1) ◽  
Author(s):  
Christian Siebel ◽  
Claudia Lanvers-Kaminsky ◽  
Gudrun Würthwein ◽  
Georg Hempel ◽  
Joachim Boos
Keyword(s):  
Point Of Care ◽  
Storage Period ◽  
Drug Level ◽  
Hplc Method ◽  
Clinical Samples ◽  
Long Term Storage ◽  
Low Concentrations ◽  
Degradation Pattern ◽  
One Year

Abstract The widespread clinical use of the cytostatic doxorubicin together with the induction of chronic cardiomyopathy necessitates the conduct of further pharmacokinetic trials. Novel analytical technologies suitable for point-of-care applications can facilitate drug level analyses but might be prone to interferences from structurally similar compounds. Besides the alcohol metabolite doxorubicinol, aglycone metabolites of doxorubicin might affect its determination in plasma. To evaluate their analytical relevance, a validated HPLC method for the quantification of doxorubicin, doxorubicinol and four aglycones was used. The degradation pattern of doxorubicin in plasma under long-term storage was analysed with respect to the formation of aglycone products. In addition, overall 50 clinical samples obtained within the EPOC-MS-001-Doxo trial were analysed. Substantial degradation of doxorubicin in plasma occurred within a storage period of one year, but this did not lead to the formation of aglycones. In clinical samples, 7-deoxydoxorubicinolone was the major aglycone detectable in 35/50 samples and a concentration range of 1.0–12.7 µg L−1. If at all, the other aglycones were only determined in very low concentrations. Therefore, analytical interferences from aglycones seem to be unlikely with the exception of 7-deoxydoxorubicinolone whose concentration accounted for up to 65% of the doxorubicin concentration in the clinical samples analysed.

scholarly journals LC Determination and Stability Assessment of Macrolide Antibiotics Azithromycin and Spiramycin in Bulk and Tablet Samples

2015 ◽  
Vol 47 ◽  
pp. 1-10 ◽  
Author(s):  
A. Mahmoudi
Keyword(s):  
Detection Limit ◽  
Ambient Temperature ◽  
Flow Rate ◽  
Mobile Phase ◽  
Reversed Phase ◽  
Hplc Method ◽  
Uv Detection ◽  
Macrolide Antibiotics ◽  
Stability Assessment ◽  
Development And Validation

Development and validation of rapid HPLC method for quantifying macrolide antibiotics azithromycin (AZI) and spiramycin (SPI) in bulk and tablet samples is described. Determination was performed on a reversed phase C18 ODB column (250×4.6 nm I.D) at ambient temperature, and employing a UV-detection set at 210 nm. The mobile phase consists of acetonitrile –2-methyl-2-propanol–hydrogenphosphate buffer, pH 6.2, with 1.8% triethylamine (32:8: up to 100, v/v/v), delivered at a flow-rate of 1.1 mL min-1. The assay is linear in concentration ranges of: 0.004–4.8 and 0.0003–1.2 mg mL−1 for azithromycin and spiramycin, respectively, with detection limit of 0.02% for SPI and 0.03% for AZI. Recovery experiments revealed recovery of 98.51–100.82%. The applicability of this method in stability assessment studies is evaluated.

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