Simple and ultra-fast recognition and quantitation of compounded monoclonal antibodies: Application to flow injection analysis combined to UV spectroscopy and matching method

Jaccoulet, Emmanuel; Schweitzer-Chaput, A.; Toussaint, Balthazar; Prognon, Patrice; Caudron, Éric

doi:10.1016/j.talanta.2018.05.042

Cited by 11 publications

(9 citation statements)

References 30 publications

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“…Except for freeze-thawing of bevacizumab, the ID test shows a potential of the FIA approach combined to the least square matching algorithm to detect degraded mabs. The region 275-300 nm has been validated to explain the highest variability between mabs (e.g., bevacizumab, rituximab, nivolumab) from our previous study 28 . Tyrosine and tryptophan residues contribute to the UV absorption in this region.…”

Section: Discussionmentioning

confidence: 86%

“…The concentration of each compounded mabs before and after the stress was determined by FIA using the validated quantification process as described on our previous study 28 . Briefly, a calibration curve of the area under the curve of the FIA signal, set at 280 nm, as a function of the concentration ranging from 0.5 to 20 mg/mL and 0.5 to 5 mg/mL was performed for bevacizumab and nivolumab respectively.…”

Section: Quantification Of the Compounded Monoclonal Antibodiesmentioning

confidence: 99%

“…The algorithm assigned the name of the drug for which the spectrum matches with the spectrum of the sample. The approach was optimized and validated in a previous study 28 .…”

Section: Identification Of the Compounded Monoclonal Antibodiesmentioning

confidence: 99%

“…Such changes in the spectrum can be accurately detected with recent available DAD 22 . In previous work, we optimized and validated the FIA approach for the identification based on the spectral recognition using simple matching method as well as the quantification of compounded mabs before their infusion 28 . Identification was performed from the native spectrum of the mabs and their associated match scores.…”

Section: Introductionmentioning

confidence: 99%

See 3 more Smart Citations

Forced Degradation of Monoclonal Antibodies After Compounding: Impact on Routine Hospital Quality Control

Jaccoulet

Daniel

Prognon

et al. 2019

Journal of Pharmaceutical Sciences

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Section: Discussionmentioning

confidence: 86%

Section: Quantification Of the Compounded Monoclonal Antibodiesmentioning

confidence: 99%

“…The algorithm assigned the name of the drug for which the spectrum matches with the spectrum of the sample. The approach was optimized and validated in a previous study 28 .…”

Section: Identification Of the Compounded Monoclonal Antibodiesmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

See 2 more Smart Citations

Forced Degradation of Monoclonal Antibodies After Compounding: Impact on Routine Hospital Quality Control

Jaccoulet

Daniel

Prognon

et al. 2019

Journal of Pharmaceutical Sciences

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“…Different strategies are applied in the hospital pharmacy. One approach consists of Fourier Transform Infrared-UV spectrophotometry11 and Raman spectroscopy,12 13 and other techniques have been developed such as flow injection analysis and reverse phase high-performance liquid chromatography (RP-HPLC) with a diode array detector (DAD) 14 15…”

Section: Introductionmentioning

confidence: 99%

Performance evaluation of the HPLC diode array and evaporative light scattering detection for the implementation of dose-banded gemcitabine infusion bags

Stalder

André²,

Mahi³

et al. 2023

Eur J Hosp Pharm

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BackgroundDose banding (DB) was used to optimise the individualisation of patient treatments with gemcitabine (Gem) in order to improve workload planning at the pharmacy of the University Hospital Centre of Besançon (UHCB). A new simple and fast high-performance liquid chromatographic (HPLC) method was also developed for the quantification of Gem without dilution of the infusion bags.MethodsIndividual doses of Gem preparations were retrospectively analysed over a 1-year period to determine the frequency of prepared doses. Using a maximum gap of 7.5% around the doses chosen, the selected Gem standard doses were 1400 mg, 1600 mg, 1800 mg and 2000 mg. Following the DB scheme, the frequency of prescription of standard and individualised Gem doses was analysed over a period of 10 months. The four selected Gem standard doses were aseptically prepared in polyolefin infusion bags. Each series of 20 bags was stocked under refrigerated storage conditions (4°C) for up to 84 days. The quantification of Gem without dilution of the infusion bags was obtained by the development of a HPLC method coupled to a diode array detector (DAD) or an evaporative light scattering detector (ELSD).ResultsDuring the 10-month period following implementation of the DB, 75.6% of the 1266 prescribed doses were covered by the four standardised preparations. The number of different Gem doses was reduced from 183 to 55. Concerning the Gem quantification, both heteroscedasticity and non-linearity were observed with DAD. Using an ELSD, the trueness values were between 98.59% and 101.52% with excellent repeatability values between 0.66% and 1.42%.ConclusionA new HPLC method has been developed for the quantification of Gem without dilution of the infusion bags prepared in advance as a result of a target DB scheme successfully implemented in our pharmacy department.

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Quality control of cytostatic drug preparations—comparison of workflow and performance of Raman/UV and high-performance liquid chromatography coupled with diode array detection (HPLC-DAD)

et al. 2021

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Simple and ultra-fast recognition and quantitation of compounded monoclonal antibodies: Application to flow injection analysis combined to UV spectroscopy and matching method

Cited by 11 publications

References 30 publications

Forced Degradation of Monoclonal Antibodies After Compounding: Impact on Routine Hospital Quality Control

Forced Degradation of Monoclonal Antibodies After Compounding: Impact on Routine Hospital Quality Control

Performance evaluation of the HPLC diode array and evaporative light scattering detection for the implementation of dose-banded gemcitabine infusion bags

Quality control of cytostatic drug preparations—comparison of workflow and performance of Raman/UV and high-performance liquid chromatography coupled with diode array detection (HPLC-DAD)

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