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2023 White Paper on Recent Issues in Bioanalysis: ISR for ADA Assays, the Rise of dPCR vs qPCR, International Reference Standards for Vaccine Assays, Anti-AAV TAb Post-Dose Assessment, NanoString Validation, ELISpot as Gold Standard (Part 3 – Recommendations on Gene Therapy, Cell Therapy, Vaccines Immunogenicity & Technologies; Biotherapeutics Immunogenicity & Risk Assessment; ADA/NAb Assay/Reporting Harmonization)
2023 White Paper on Recent Issues in Bioanalysis: ISR for ADA Assays, the Rise of dPCR vs qPCR, International Reference Standards for Vaccine Assays, Anti-AAV TAb Post-Dose Assessment, NanoString Validation, ELISpot as Gold Standard (Part 3 – Recommendations on Gene Therapy, Cell Therapy, Vaccines Immunogenicity & Technologies; Biotherapeutics Immunogenicity & Risk Assessment; ADA/NAb Assay/Reporting Harmonization)
The 17th Workshop on Recent Issues in Bioanalysis (17th WRIB) took place in Orlando, FL, USA on June 19–23, 2023. Over 100...
Revolutionizing depression diagnosis: earwax analysis for cortisol and beyond
Revolutionizing depression diagnosis: earwax analysis for cortisol and beyond
The authors have no financial involvement with any organization or entity with a financial interest in or financial confli...
Bioanalytical Quality Assurance: a Tesla with a trafficator?
Bioanalytical Quality Assurance: a Tesla with a trafficator?
The author has no financial involvement with any organization or entity with a financial interest in or financial conflict...
Covalent organic frameworks: spotlight on applications in the pharmaceutical arena
Covalent organic frameworks: spotlight on applications in the pharmaceutical arena
Covalent organic frameworks (COFs) have much potential in the field of analytical separation research due to their distinc...
GC–MS/MS analysis of synthetic cannabinoids 5F-MDMB-PICA and 5F-CUMYL-PICA in forensic cases
GC–MS/MS analysis of synthetic cannabinoids 5F-MDMB-PICA and 5F-CUMYL-PICA in forensic cases
Aim: Validate a method to quantify 1-(5-fluoropentyl)-N-(2-phenylpropan-2-yl)-1H-indole-3-carboxamide (5F-CUMYL-PICA) and ...
Greenness assessment of microextraction techniques in therapeutic drug monitoring
Greenness assessment of microextraction techniques in therapeutic drug monitoring
Aim: In this study, we evaluated the greenness and whiteness scores for microextraction techniques used in therapeutic dru...
Determination of meropenem in capillary plasma microsamples using LC–MS/MS
Determination of meropenem in capillary plasma microsamples using LC–MS/MS
Background: The measurement of meropenem plasma concentrations is employed for dosing regimen individualization. The aim o...
In vitro dissolution equivalence of Jordanian sildenafil generics via validated, stability-indicating HPLC method
In vitro dissolution equivalence of Jordanian sildenafil generics via validated, stability-indicating HPLC method
This study was conducted to compare dissolution profiles of four Jordanian registered sildenafil (SDF) products to the ori...
Novel assay format for total anti-adeno-associated virus antibody detection with low capsid consumption and built-in specificity control
Novel assay format for total anti-adeno-associated virus antibody detection with low capsid consumption and built-in specificity control
Aim: To develop an assay format for detection of total anti-adeno–associated virus 2 (AAV2) antibodies with low capsid mat...
Determination of carbamazepine in fingerprints: a feasibility study to evaluate adherence in epilepsy patients
Determination of carbamazepine in fingerprints: a feasibility study to evaluate adherence in epilepsy patients
Background: Fingerprint drug concentrations can be used as a noninvasive and convenient alternative to evaluate adherence ...
An LC–MS/MS method for determination of the bromodomain inhibitor ZEN-3694 and its metabolite ZEN-3791 in human plasma
An LC–MS/MS method for determination of the bromodomain inhibitor ZEN-3694 and its metabolite ZEN-3791 in human plasma
We have developed and validated a novel LC–MS/MS method for the simultaneous quantification of ZEN-3694 and its active met...
Use of RNA biomarkers in the antidoping field
Use of RNA biomarkers in the antidoping field
There is growing evidence that various RNA molecules can serve as biomarkers for clinical diagnoses. Over the last decade,...
Determination of aloesone in rat plasma by LC–MS/MS spectrometry and its application in a pharmacokinetic study
Determination of aloesone in rat plasma by LC–MS/MS spectrometry and its application in a pharmacokinetic study
Aim: We aimed to develop a rapid and accurate LC–MS/MS method for determining the concentration of aloesone in rat plasma,...
A novel biomarker assay qualification strategy for rare human matrices – a case study of biomarkers in aqueous humor
A novel biomarker assay qualification strategy for rare human matrices – a case study of biomarkers in aqueous humor
Background: Measuring pharmacodynamic biomarkers near the therapeutic site of action presents considerable challenges for ...
An interview with Bioanalysis: speaking with the 2023 International Reid Bioanalytical Forum bursary award winners, part 1
An interview with Bioanalysis: speaking with the 2023 International Reid Bioanalytical Forum bursary award winners, part 1
The authors have no financial involvement with any organization or entity with a financial interest in or financial confli...
Enzymes as indispensable markers in disease diagnosis
Enzymes as indispensable markers in disease diagnosis
Enzymes have been used for disease diagnosis for many decades; however, advancements in technology like ELISA and flow cyt...
Development and validation of bioanalytical methods to support clinical study of disitamab vedotin
Development and validation of bioanalytical methods to support clinical study of disitamab vedotin
Disitamab vedotin (RC48), a humanized anti-HER2 antibody conjugated with monomethyl auristatin E (MMAE), is the first anti...
The challenges for implementing Good Clinical Practices in the bioanalytical laboratory: a discussion paper from the European Bioanalysis Forum
The challenges for implementing Good Clinical Practices in the bioanalytical laboratory: a discussion paper from the European Bioanalysis Forum
This manuscript reports back from the discussion in the European Bioanalysis Forum community on the challenges observed wh...
Pharmacokinetics and apparent Michaelis constant for metabolite conversion of sorafenib in healthy and hepatocellular carcinoma-bearing rats
Pharmacokinetics and apparent Michaelis constant for metabolite conversion of sorafenib in healthy and hepatocellular carcinoma-bearing rats
Aim: Investigation of the pharmacokinetics of sorafenib (SRF) in rats with hepatocellular carcinoma (HCC). Methods: A repr...
An interview with Bioanalysis: speaking with the 2023 Reid bursary award winners – part 2
An interview with Bioanalysis: speaking with the 2023 Reid bursary award winners – part 2
The 25th edition of the International Reid Bioanalytical Forum (REID) was held at the Cambridge Belfry (Cambourne, UK) bet...
Cloud security in a bioanalytical world: considerations for use of third-party cloud services for bioanalysis
Cloud security in a bioanalytical world: considerations for use of third-party cloud services for bioanalysis
While using the cloud environment for various functions has become commonplace, relatively little attention has been given...
Free hemoglobin determination at patients' bedside to evaluate hemolysis
Free hemoglobin determination at patients' bedside to evaluate hemolysis
Background: The authors report the relevance of using a point of care test (Helge®) for free hemoglobin determination and ...
Signal-to-noise ratio to assess magnitude, kinetics and impact on pharmacokinetics of the immune response to an adalimumab biosimilar
Signal-to-noise ratio to assess magnitude, kinetics and impact on pharmacokinetics of the immune response to an adalimumab biosimilar
Background: The antidrug antibody (ADA) signal-to-noise (S/N) ratio was explored as a novel immunogenicity measure to eval...
Quality control of psychoactive substances in human breastmilk samples from a human milk bank by disposable pipette extraction–gas chromatography–mass spectrometry
Quality control of psychoactive substances in human breastmilk samples from a human milk bank by disposable pipette extraction–gas chromatography–mass spectrometry
The lack of data regarding infant exposure to drugs of abuse consumed by lactating mothers has become a major health conce...
Development and validation of a UPLC–MS/MS method for determination of SYHA1807 in a first-in-human study
Development and validation of a UPLC–MS/MS method for determination of SYHA1807 in a first-in-human study
Background: SYHA1807 is a novel lysine specific demethylase 1 inhibitor being developed for the treatment of small-cell lu...
Bioanalysis of six antibiotics from volumetric microsamples: a new tool for precision dosing in critically ill children
Bioanalysis of six antibiotics from volumetric microsamples: a new tool for precision dosing in critically ill children
Background: Volumetric absorptive microsamples (VAMS) can support pharmacokinetic / pharmacodynamic studies. We present th...
Development, validation and application of a liquid chromatography–tandem mass spectrometry method for quantifying lurasidone in dried blood spot samples
Development, validation and application of a liquid chromatography–tandem mass spectrometry method for quantifying lurasidone in dried blood spot samples
Background: A liquid chromatography–tandem mass spectrometry method for quantifying lurasidone in rat dried blood spot (DB...
A singlicate immunogenicity method to detect anti-polyethylene glycol antibodies: pre- and post-dose of PEGylated therapies
A singlicate immunogenicity method to detect anti-polyethylene glycol antibodies: pre- and post-dose of PEGylated therapies
Aim: Preexisting anti-polyethylene glycol (PEG) antibodies (APAs) may affect the efficacy and safety of PEGylated compound...
Challenges and current advances in the methodology of thyroglobulin measurements
Challenges and current advances in the methodology of thyroglobulin measurements
Thyroglobulin (Tg) is a large protein secreted exclusively by the thyroid gland. In a clinical setting, it is measured for...
Meet the Editorial Board – an interview with Min Meng and transitions from small regional labs to global CRO
Meet the Editorial Board – an interview with Min Meng and transitions from small regional labs to global CRO
Min Meng received her PhD in biomedicinal chemistry from the School of Pharmacy, University of Maryland, in 1996. From 199...
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