Managing the transition: switching bioanalytical laboratories during a clinical trial - a sponsor's perspective [0.03%]
管控中的转换：临床试验期间生化分析实验室的更换-申办方视角
Ketaki Deshpande,Mira Hong,Mark Ware et al.
Ketaki Deshpande et al.
Bioanalytical (BA) data are foundational to clinical trial integrity and regulatory success. Yet, circumstances such as regulatory noncompliance, operational disruptions, resource limitations, or evolving analytical needs can necessitate a ...
Correction [0.03%]
改正措施
Published Erratum
Bioanalysis. 2026 Jan 19:1. DOI:10.1080/17576180.2026.2619351 2026
Accurate quantification of anti-drug antibodies against each unique Fab of a bispecific antibody using an ECL bridging assay [0.03%]
使用ECL桥联测定法精确量化针对双特异性抗体每个独特Fab区的抗药抗体
Blake A Rowe,Kimberly J Reese,Kelly McGrath et al.
Blake A Rowe et al.
Aim: To develop an anti-drug antibody (ADA) assay for a bispecific antibody (bsAb) we will refer to as Drug-1, and to quantify the ADAs against each specific fragment antigen-binding (Fab) site of Drug-1. ...
Augmenting immunogenicity workflows with AI and real-world evidence: failure points, tools, and a closed-loop operational blueprint [0.03%]
利用人工智能和真实世界证据增强免疫原性工作流程：失败点、工具及闭环运营蓝图
Ahmad Z Al Meslamani,Anan S Jarab,Eman Merghani Ali Mohammed
Ahmad Z Al Meslamani
Immunogenicity undermines the safety and effectiveness of biologics and emerging modalities. Routine workflows are constrained by drug/target interference in binding assays, matrix and dilution biases in functional assays, fragile cellular/...
FALCON-qPCR: a new method for the quantification of oxidative lesions in mitochondrial DNA [0.03%]
FALCON-qPCR：一种定量线粒体DNA氧化损伤的新方法
Veronica Bazzani,Eve Harding,Szymon Balinski et al.
Veronica Bazzani et al.
Accurate quantification of oxidative mitochondrial DNA (mtDNA) lesions remains technically challenging due to the limitations of existing assays, which often require large sample inputs, multi-day workflows, and offer limited sensitivity. H...
Naohito Yamada,Makoto Niwa,Hisanori Hara et al.
Naohito Yamada et al.
The 16th Japan Bioanalysis Forum (JBF) Symposium was held from March 3 to 5, 2025, at the Himeji Culture and Convention Center (Arcrea Himeji). The theme for the symposium was 'Bioanalyst Network: Spread and Circulation of Knowledge.' This ...
A simple, sensitive and rapid bioanalytical method for quantifying cannabidiol (CBD), 7-OH-CBD and 7-COOH-CBD in human plasma [0.03%]
一种简单、敏感且快速的人血浆中大麻二酚(CBD)、7-羟基大麻二酚(7-OH-CBD)和7-羧基大麻二酚(7-COOH-CBD)定量生物分析方法
Nattapon Jaisupa,Michael Ashton,Sofia Birgersson
Nattapon Jaisupa
Background: Reliable methods for measuring plasma concentrations of cannabidiol (CBD) and its metabolites are essential for pharmacokinetic studies. Several methods have been published, some involve complex procedures. Th...
Development and validation of a bioanalytical method to quantify povorcitinib in human skin with clinical application [0.03%]
人皮肤中普福西浓度测定及临床应用的生物分析方法的建立和验证
Zhiyin Xun,Lin Zhang,Hongjin Wen et al.
Zhiyin Xun et al.
Aim: Quantification of drug concentrations in human skin is essential for understanding mechanisms of action in dermatologic therapeutics but remains analytically challenging. The study aimed to develop and validate a sta...
Streamlined neutralizing antibody assay development: overcoming serum interference, utilization of DOE and automation [0.03%]
简化中和抗体检测开发：克服血清干扰、实验设计及自动化利用
Kelly Ngoc Pham,Nazneen Bano,Leonard J Rubinstein et al.
Kelly Ngoc Pham et al.
Objective: This study detailed the troubleshooting and optimization of a challenging neutralizing antibody (NAb) assay using a previously published PEG precipitation, Acid Dissociation, and Biotin-drug as Assay Drug (PABA...
2025 White Paper on Recent Issues in Bioanalysis: Redosing Patients with AAV Gene Therapy; CRS Immunogenicity Risk; Shedding Assays; NHP Studies Immunogenicity; CMC vs Bioanalytical Assays; Artificial Intelligence-Powered Genomic Pipelines for NGS (PART 3A - Recommendations on Gene, Cell, and Vaccine Therapies Immunogenicity & Technologies; Biot [0.03%]
2025年生物分析近期问题白皮书：AAV基因治疗患者的重新给药；CRS免疫原性风险；脱落试验；非人灵长类动物研究的免疫原性；CMC与生物分析方法；用于NGS的人工智能驱动基因组流水线（第3A部分-关于基因、细胞和疫苗疗法的免疫原性和技术的建议）
Omar Tounekti,Sophie Shubow,Sarah Wassmer et al.
Omar Tounekti et al.
The 19th Workshop on Recent Issues in Bioanalysis (19th WRIB) took place in New Orleans, LA, USA on April 7-11, 2025. Over 1200 professionals representing pharma/biotech companies, CROs, and multiple regulatory agencies convened to actively...