Session Details
[P2]Poster Presentation
Tue. Mar 4, 2025 10:55 AM - 11:55 AM JST
Tue. Mar 4, 2025 1:55 AM - 2:55 AM UTC
Tue. Mar 4, 2025 1:55 AM - 2:55 AM UTC
Poster Session(1st floor)
[P2-01]Multi-laboratory study of LC/MS method development for the quantification of 3003pep in plasma
*Rika Ishikawa1, Kosuke Saito1, Mikio Shirasaki2, Koichi Shiga2, Naoko Arashida3, Kazuki Yamamoto3, Masayoshi Mizuochi4, Aki Koyama4, Kayo Iwasaki5, Suguru Fukuda5, Yuki Kishino6, Hitomi Shimoda6, Hitoshi Uchiyama7, Rikako Une7, Ryo Yamato8, Ryoya Goda9, Takashi Misawa1, Yosuke Demizu1, Yoshiro Saito1, Ruri Kikura-Hanajiri 1 (1. National Institute of Health Sciences, 2. Axcelead Drug Discovery Partners, Inc., 3. Ajinomoto. Co., Inc., 4. CMIC Pharma Science Co., Ltd., 5. Shin Nippon Biomedical Laboratories, Ltd., 6. Daiichi Sankyo Co., Ltd., 7. Towa Pharmaceutical Co., Ltd., 8. Mediford Corporation, 9. Future Peak)
[P2-02]Points to consider for using ADA screening assay signal-to-noise ratio (S/N) as an alternative to titer in immunogenicity assessment
*Kazuko Nishimura1, Hiroko Shibata1, Emu Ikarigawa2, Takuo Suzuki1, Yasuo Suzuki2, Yoshiro Saito3, Akiko Ishii-Watabe1 (1. Division of Biological Chemistry and Biologicals, National Institute of Health Sciences, 2. Ginza Central Clinic, 3. National Institute of Health Sciences)
[P2-03]Improvement of the Enzyme-Linked Aptamer Assay for the Bioanalysis of Rituximab
*Chiho Hirayama1, Nao Kobayashi1, Hiroyuki Tasaki1, Aogu Furusho1, Kenji Kojima1, Kenichiro Todoroki1 (1. Dept. of Integrated Pharmaceutical and Nutritional Sciences, University of Shizuoka)
[P2-04]Considerations and Strategies for Biodistribution Assessment of Induced Pluripotent Stem Cell-derived Cell Therapy Products: A Case Study with Pancreatic Islet-like Cells
*Miyu Nakayama1, Yuu Moriya1, Hikaru Ueno2, Takeshi Watanabe1, Hideki Hirabayashi1, Syunsuke Yamamoto1 (1. Takeda Pharmaceutical Company Limited, 2. Orizuru Therapeutics, Inc.)
[P2-05]Development of Automatic Data Processing System for Bioanalytical Method Validation and Sample Analysis Using LC/MS
*Yuya Hidoh1, Kazunori Sasaki2, Kazushi Goto2, Yoshiko Himeda2, Takuya Kuno1, Yasuhiro Sawai1, Fumiaki Ayabe2, Yosuke Kaneko1 (1. Department of Drug Metabolism and Pharmacokinetics Preclinical Reserch Tokushima Reserch Center for Drug Discovery, 2. Information Management Office Preclinical Reserch Tokushima Reserch Center for Drug Discovery)
[P2-06]Multidimensional Information-Based Quality Assessment of Proteins and Exosomes Using a Cross-Reactive Sensor
*Yoichi Aoki1, Tomoo Izumi1, shumpei hitosugi1, Rieko Takahashi1 (1. KONICAMINOLTA,INC Technology Development Headquarters)
[P2-07]Automated and Robust Identification of Scrambled Disulfide Bonds in Biotherapeutics
*Tsubasa Ohashi1, Stephen Kok2, Arnd Brandenburg1 (1. Genedata AG, Basel, Switzerland, 2. Genedata Inc., San Francisco, CA, USA)
[P2-08]End-to-end Data Integration Platform for Bioassays from Preclinical and Clinical Studies
*Ryoko Ishihara1, Sebastien Ribrioux2, Justyna Lisowska 2, Hideki Shimohiro1 (1. Genedata KK, Tokyo, Japan, 2. Genedata AG, Basel, Switzerland)
[P2-09]The Path to IDE/IVDR: Navigating the Evolving Regulatory Guidelines for Gene Therapies
*Lynn Kamen1, Luke Armstrong1, Will Williams1, Robert Nelson2, Jim McNally1 (1. BioAgilylitx Labs, 2300 Englert Drive, Durham NC 27713, USA, 2. BioAgilylitx Labs, Lademannbogen 10, 22339 Hamburg, Germany)
[P2-10]Measurement of Various ADC Component Concentrations and DAR Profiling Using a Single Plasma Sample in a NHP Toxicology Study via Hybrid LC-MS
*Pei Zhang1, Yifan Wang1, Wenqin Xu1, Jing Huang1, Xiaoying Jin1, Lan Li2 (1. BA Dept. of WuXi AppTec, (Suzhou) Co., Ltd., 2. BA Dept. of WuXi AppTec, (Shanghai) Co., Ltd)
[P2-11]Establishment of an immunocapture-free LC-MS/MS method for determination of conjugated payload in human serum to support a clinical trial of an ADC drug
*Yanjun Hu1, Wenzhong Zhang1, Shengni Li1, Jing Lan1, Chenpu Zhang1, Wenzhong Liang1, Lan Li1 (1. Bioanalytical Services Department, WuXi AppTec Co., Ltd.)
[P2-12]Visualization of Cut Point Data for Optimized Application in Anti-Drug Antibody Assays to Support Immunogenicity Testing
Derrick Johnson1, *Hisanori Hara1, Tyler Ison1, Amanda Clancy1, David Shields1, Kim Krug1, Ronald R. Bowsher1 (1. B2S Life Sciences)
[P2-13]The potential of DNA aptamers for quantifying the concentration of large molecule in plasma using electrochemiluminescence immunoassay
- Application to the quantification of bevacizumab in cynomolgus monkey plasma -
*Haruka Shirosawa1, Yosuke Kotani1, Suguru Fukuda1, Akihito Shimoi1, Kenichiro Todoroki2 (1. Shin Nippon Biomedical Laboratories, Ltd., 2. School of Pharmaceutical Sciences, University of Shizuoka)
[P2-14]Development of an analytical method for the determination of oligonucleotides by HPLC-FL (Short Probe)
*Kazuhiro Takeuchi1, Tsuyoshi Kawahara1, Takeshi Okuzono1, Kenta Hashizume1, Toshiyuki Tanaka 2, Koichi Shibusawa2 (1. Dept. Contract Research Department, Drug Development Solutions Center, of SEKISUI MEDICAL CO., LTD., 2. Dept. Core Technology, Tsukuba Research Institute, of SEKISUI MEDICAL CO., LTD.)
[P2-15]Exploration of Effective IS Structures for Bioanalysis of Oligonucleotide Therapeutics Using LC-MS/MS
*Masayoshi Mizuochi1, Yoshiharu Hayashi1, Aki Koyama1 (1. CMIC Pharma Science Co., Ltd.)
[P2-16]Comprehensive Analysis of Human Immune Cells Using Mass Cytometry
*Mamoru Tanaka1, Ayaka Mayumi1, Natsumi Uchida1, Hirotsugu Yamaki1, Hideki Harada1, Tamiki Mori1, Seiji Kinoshita1 (1. Business Management Division, Clinical Trial Business Segment, Bioanalysis Department)