Long Yuan

Impact of Extraction Recovery and Matrix Effect on qPCR-based Biodistribution Analysis in Gene Therapy: Strategies for Mitigation

Ting Jiang, Zhaomeng Feng, Long Yuan

In DNA biodistribution studies, genomic DNA (gDNA) is commonly used as a normalizer for quantifying vector DNA (vDNA) to account for multiple variations including tissue type, sample input, DNA extraction efficiency, etc. Typically, the concentrations of both vDNA and gDNA in elution …

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Clinical utility of the targeted next-generation sequencing for detection of Mycoplasma pneumoniae and antimicrobial resistance genes for adults

Long Yuan, Zhuofan Liu, Wenmei Zeng, Zie Zhan et autres

BACKGROUND: Mycoplasma pneumoniae pneumonia (MPP) is common in children, and its incidence among adolescents and adults has been increasing in recent years. Targeted next-generation sequencing (tNGS) is a rapid, accurate and comprehensive method for pathogen detection; however, few studies have investigated its …

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Overcoming inconsistent DNA extraction recovery across tissue types in qPCR assays supporting biodistribution studies

Ting Jiang, Zhaomeng Feng, Long Yuan

AIMS: DNA biodistribution studies are essential in the development of cell and gene therapies. A key step of these studies is the extraction of vector DNA (vDNA) and genomic DNA (gDNA) from complex biological samples. In this work, key DNA extraction parameters …

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Development of a Flow Process to tert -Butyl 4-(6-Chloropyridin-2-yl)piperidine-1-carboxylate

Aaron F. Baldwin, Nga M., Xican He, Craig J. Knight et autres

This paper outlines the development of a continuous manufacturing process for producing the key compound tert -butyl 4-(6-chloropyridin-2-yl)piperidine-1-carboxylate. A 3-step process, performed in batch, had been utilized to deliver significant quantities of the target compound. By employing the same bond-forming chemistry, we …

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2025 White Paper on Recent Issues in Bioanalysis: What is the Future of Bioanalytical LIMS? AI/ML Integration in Bioanalysis; Tear Sample Collection; Radiolabeled Mass Balance Studies; Chiral Assays; Bioanalysis of Antibody-Oligonucleotide & Bicycle Drug Conjugates ( PART 1A – Recommendations on Mass Spectrometry Assays, Chromatography, Sample Preparation and Regulated Bioanalysis Sampling, Validating, Analyzing & Reporting PART 1B – Regulatory Agencies’ Input on Regulated Bioanalysis/BMV)

John Wojcik, Mark G. Qian, Anton I. Rosenbaum, Estelle M. Maes et autres

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 discuss the most current topics of interest …

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Hybridization liquid chromatography-mass spectrometry for quantitative bioanalysis of oligonucleotides: The upcoming paradigm shift

Long Yuan

• Hybridization LC-MS is rapidly growing as a new bioanalytical technique for oligonucleotides • This paper provides a comprehensive review of hybridization LC-MS methodologies • Strategies and challenges for both single-stranded and double-stranded oligonucleotides discussed • Key considerations, novel applications and future …

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A Novel Hybrid LC-MS/MS Methodology for the Quantitative Bioanalysis of Antibody-siRNA Conjugates

Zifeng Song, Long Yuan

Small interfering RNA (siRNA) is a new class of oligonucleotide therapeutics that is rapidly growing in drug research and development for the treatment of various diseases. One major challenge for siRNA therapeutics is their inefficient delivery to target tissues by systemic administration. …

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Examining hybridization-based LC–MS methodologies for the bioanalysis of siRNA analytes

Karan Agrawal, Wenying Jian, Long Yuan

Hybridization-based LC-MS is rapidly emerging as a bioanalytical platform for oligonucleotides, particularly when both high sensitivity and high specificity are needed. When used to analyze single-stranded antisense oligonucleotide (ASO) therapeutics, the workflows are relatively well established, but the analysis of double-stranded small …

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Quantitative Determination of Click-Reactive Antisense Oligonucleotide and Its Reactivity in Rat Brains by Hybridization LC-MS/MS to Support Pretargeted PET Imaging

Di Jiang, Brendon E. Cook, Thomas C. Pickel, Long Yuan

High Resolution Image Download MS PowerPoint Slide Antisense oligonucleotide (ASO) therapeutics are rapidly increasing in prevalence for the treatment of neurodegenerative diseases. A novel pretargeted positron emission tomography (PET) imaging methodology based on in vivo click chemistry was developed recently to assess …

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Identification and quantitative analysis of DNA damage products using LC-MS-MS.

Long Yuan

Identification and quantitative analysis of DNA damage products using LC-MS-MS.

PET imaging of antisense oligonucleotide distribution in rat and nonhuman primate brains using click chemistry

Brendon E. Cook, Thomas C. Pickel, Sangram Nag, Philippe N. Bolduc et autres

Determination of a drug’s biodistribution is critical to ensure that it reaches the target tissue of interest. This is particularly challenging in the brain, where invasive sampling methods may not be possible. Here, we present a pretargeted positron emission tomography (PET) imaging …

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Gushan virus: a newly discovered virus found in mosquitoes of Shandong, China

Long Yuan, Yongchao Yang, Wenbing Zhu, Shuo Feng et autres

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