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Bioanalysis

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https://read.qxmd.com/read/30767660/effective-presentation-of-immunogenicity-risk-assessments-and-related-data-in-regulatory-dossiers
#1
Paul Chamberlain
The purpose of this article is to provide practical advice about how to present immunogenicity-related information in regulatory dossiers, with a particular focus on a model for an Integrated Summary of Immunogenicity to be submitted in the marketing authorization application for novel biopharmaceutical products in ICH regions (EU, USA and Japan). A format that links the analysis of potential risk factors to a justification of the methodology applied for risk evaluation and conclusions for risk mitigation is presented as a model that can be adapted according to the weight of evidence to be submitted in support of the assessment of impact on overall clinical benefit versus risk for the particular situation...
February 15, 2019: Bioanalysis
https://read.qxmd.com/read/30767560/toward-highly-sensitive-and-reproducible-lc-ms-ms-analysis-of-mk-8591-phosphorylated-anabolites-in-human-peripheral-blood-mononuclear-cells
#2
Li Sun, Cynthia Chavez-Eng, Kerry L Fillgrove, Bing Lu, Iris Xie, Deanne Jackson Rudd, Sheila Breidinger, Melanie Anderson, Suzie Yeh, Rena Zhang, Eric J Woolf
AIM: MK-8591 (EFdA), a novel anti-HIV nucleoside analog, is converted to mono-, di- and tri-phosphates (MK-8591-MP, MK-8591-DP and MK-8591-TP) intracellularly, among which MK-8591-TP is the active pharmacological form. An ultrasensitive LC-MS/MS assay was required to measure MK-8591-DP and MK-8591-TP levels in human peripheral blood mononuclear cells (PBMCs). Sensitivity and reproducibility were major bottlenecks in these analyses. MATERIALS AND METHODS: Human PBMCs were isolated from blood and lysed with 70/30 methanol/RPMI-1640...
February 15, 2019: Bioanalysis
https://read.qxmd.com/read/30767556/a-practical-workflow-for-capillary-microsampling-in-nonclinical-studies
#3
Linna Wang, Bonnie Wang, Kristina D Chadwick, Ting Su, Raja Mangipudy, Renuka C Pillutla, Qin C Ji
AIM: The result of investigation on the procedure of sample handling and bioanalysis of small volume of plasma sample for nonclinical studies stored in 0.5-ml micronic tubes was reported. Results/methodology: Sample integrity of the small volume (25 μl) during long-term storage and the feasibility and data reliability of performing multiple re-assays on the small volume sample using 5 μl aliquot per analysis was evaluated. CONCLUSION: Integrity was maintained in samples (25 μl) stored for up to 1 month in 0...
February 15, 2019: Bioanalysis
https://read.qxmd.com/read/30734579/direct-quantitation-of-therapeutic-antibodies-for-pharmacokinetic-studies-using-immuno-purification-and-intact-mass-analysis
#4
Lisa A Vasicek, Xin Zhu, Daniel S Spellman, Kevin P Bateman
AIM: The quantitation of therapeutic antibodies by MS often utilizes a surrogate peptide approach. Recent enhancements in instrumentation and sample preparation have enabled quantitation by detection of the intact molecule using MS. Experimental Methods & Results: A comparison of three methods for quantitative analysis of therapeutic monoclonal antibodies including analysis after deglycosylation, after hinge digestion and at the fully intact antibody level is reported. The optimized methodology provided sensitivity down to 0...
February 8, 2019: Bioanalysis
https://read.qxmd.com/read/30672314/evaluation-of-polysaccharide-based-chiral-stationary-phases-in-modern-sfc-ms-ms-for-enantioselective-bioanalysis
#5
Liuxi Chen, Brian Dean, Xiaorong Liang
AIM: The applicability of polysaccharide-based chiral stationary phases in modern supercritical fluid chromatography (SFC)-MS/MS for chiral bioanalysis was evaluated. MATERIALS & METHODS: Ten popular polysaccharide-based chiral stationary phases (CSPs) were tested using a set of 23 drugs against three cosolvents. The effect of temperature and backpressure on separation was examined. RESULTS: The recommended order of CSPs for screening was determined...
January 23, 2019: Bioanalysis
https://read.qxmd.com/read/30672313/compatibility-of-immunogenicity-guidance-by-the-ema-and-the-us-fda
#6
Pekka Kurki
The guidelines for immunogenicity studies by the European Medicines Agency and the US FDA are based on different legislations and regulatory philosophies. In spite of the different background, the main guidelines are compatible on the scientific level, especially for new innovative therapeutic protein products. The importance of sensitive and drug-tolerant antidrug antibody assays and multidisciplinary approach to development and assessment are highlighted by both agencies. The main differences are in the field of biosimilars...
January 23, 2019: Bioanalysis
https://read.qxmd.com/read/30663344/hplc-ms-ms-based-analysis-of-everolimus-in-rabbit-aqueous-humor-pharmacokinetics-of-in-situ-gel-eye-drops-of-suspension
#7
Zhan Tang, Ling Wang, Zhifang Xia, Ming Shi, Qiao Wang, Zhajun Zhan
AIM: Everolimus is an inhibitor of mTOR which is derived from rapamycin. Its high corneal permeability and bioavailability makes it an effective treatment for ocular disorders. To study the pharmacokinetics of in situ gel eye drops of everolimus suspension after ocular administration in rabbit aqueous humor, we developed a rapid and reliable HPLC-MS/MS method. METHODOLOGY/RESULTS: Ascomycin was selected as the internal standard. HPLC-MS/MS method was used to investigate the concentration-time relationship of everolimus in rabbit aqueous humor through protein precipitation technique...
January 21, 2019: Bioanalysis
https://read.qxmd.com/read/30663332/perspectives-and-strategies-for-anti-doping-analysis
#8
Michele Protti, Roberto Mandrioli, Laura Mercolini
No abstract text is available yet for this article.
January 21, 2019: Bioanalysis
https://read.qxmd.com/read/30663327/current-direction-and-advances-in-analytical-sample-extraction-techniques-for-drugs-with-special-emphasis-on-bioanalysis
#9
Gangireddy Navitha Reddy, Aarati Dilip Zagade, Pinaki Sengupta
Analytical techniques may not be compatible or sufficiently sensitive to the analytes, unless it undergoes a specific sample extraction procedure. Sample extraction can be considered as one of the key steps in analysis. Analysis of a poorly treated sample may produce inferior quality of analytical data. Continuous advancement and development of newer sample extraction techniques such as solid phase microextraction, ultrasound, magnetically and microwave assisted magnetic extraction; electro-membrane extraction and dried blood spotting are to address the shortcomings of the existing techniques and to provide more automation, minimizing preparation time and make them high throughput...
January 21, 2019: Bioanalysis
https://read.qxmd.com/read/30663322/green-sample-preparations-for-the-bioanalysis-of-drugs-of-abuse-in-complex-matrices
#10
Gabriela de Oliveira Silveira, Ana Miguel Fonseca Pego, Jefferson Pereira E Silva, Mauricio Yonamine
The sample preparation is the most critical step involved in the bioanalytical process. When dealing with green analytical chemistry, sample preparation can be even more challenging. To fit the green analytical chemistry principles, efforts should be made toward the elimination or reduction of the use of toxic reagents and solvents, minimization of energy consumption and increased operator safety. The simplest sample preparations are more appropriate for liquid biological matrices with little interfering compounds such as urine, plasma and oral fluid...
January 21, 2019: Bioanalysis
https://read.qxmd.com/read/30663320/schizophrenia-recent-advances-in-lc-ms-ms-methods-to-determine-antipsychotic-drugs-in-biological-samples
#11
Maria Eugênia Costa Queiroz, Mônia Aparecida Lemos Pinto, Jonas Carneiro Cruz, Juliana Mayumi Ushirohira, Isabella Caroline da Silva Dias, Jaime E Cecilio Hallak
Schizophrenia is one of the most debilitating and costly illnesses worldwide. First-generation antipsychotics such as chlorpromazine and haloperidol succeeded in controlling the positive symptoms of schizophrenia, but had significant extrapyramidal effects that led to the search for new agents and the release of second-generation (or atypical) antipsychotics. These drugs had a lower risk of adverse motor symptoms. Therapeutic drug monitoring has become a useful tool to optimize schizophrenia treatment and HPLC-MS/MS has been considered the primary technique to monitor antipsychotics...
January 21, 2019: Bioanalysis
https://read.qxmd.com/read/30661375/retention-time-bracketing-for-targeted-sphingolipidomics-by-liquid-chromatography-tandem-mass-spectrometry
#12
Lina Zhu, Jieliang Zhou, Cui Liang, Yie Hou Lee
AIM: In complex biological matrixes, many sphingolipids are present with multiple reaction monitoring traces or lack of standard for verification, potentially leading to inaccurate identification and quantitation. Results/methodology: Based on these retention times of available standards, we devised a retention time bracketing approach to identify and predict sphingolipids of the same homologous series. Excellent concordance of predicted and observed retention times (<0.1 min) of sphingolipids were demonstrated...
January 21, 2019: Bioanalysis
https://read.qxmd.com/read/30661370/simultaneous-quantification-of-high-dose-naloxone-and-naloxone-3-%C3%AE-d-glucuronide-in-human-plasma-by-uhplc-ms-ms
#13
Kenneth T Kongstad, Theodoros Papathanasiou, Anders D Springborg, Trine M Lund, Mads U Werner, Dan Staerk
AIM: High-dose administration of the μ-opioid receptor inverse agonist naloxone (NX), has previously been demonstrated to reinstate nocifensive behavior in the late phase of inflammatory injuries. However, no current analytical methods can provide pharmacokinetic insight into the pharmacodynamic response of high-dose administration of NX. MATERIALS & METHODS:  Based on protein precipitation using 50 μl human plasma, NX and naloxone-β-d-glucuronide (NXG) was analysed by UHPLC-MS/MS with 6 min cycle time...
January 21, 2019: Bioanalysis
https://read.qxmd.com/read/30628464/use-of-ella-%C3%A2-to-facilitate-drug-quantification-and-antidrug-antibody-detection-in-preclinical-studies
#14
Uwe Wessels, Klaus Mackeben, Kay Stubenrauch
AIM: To explore the usability of the Ella® platform for preclinical analysis of therapeutic antibodies and antidrug antibodies (ADA). EXPERIMENTAL: Two well-established ELISAs for the measurement of human IgG and ADA were transferred to the Ella platform. ELISA and the Ella platform were compared using assay qualification data and results of preclinical sample analysis. RESULTS: The performance and results of both assays on the Ella platform were comparable to those of ELISA...
January 10, 2019: Bioanalysis
https://read.qxmd.com/read/30539646/voltammetric-analysis-of-dantrolene-and-its-active-metabolite-with-indomethacin-in-rat-plasma
#15
Marwa Aa Ragab, Mohamed A Korany, Shereen M Galal, Aya R Ahmed
AIM: Differential pulse polarography was used for the concurrent analysis of the coadministered dantrolene (DAN) and indomethacin (IND) in plasma. MATERIALS & METHODS: DAN and IND, Hanging mercury drop electrode and Britton-Robinson buffer at pH 5 were used. In plasma, cathodic reduction of DAN nitro group and its active metabolite at -0.2 V was done. IND was analyzed after carbonyl group reduction at -1.1 V. RESULTS: Drugs determination in rat plasma with good recoveries and low limit of quantitation was done...
December 12, 2018: Bioanalysis
https://read.qxmd.com/read/30539644/miniaturized-sample-preparation-methods-for-saliva-analysis
#16
Shahram Seidi, Maryam Rezazadeh, Reza Alizadeh
Saliva, as the first body fluid encountering with the exogenous materials, has good correlation with blood and plays an important role in bioanalysis. However, saliva has not been studied as much as the other biological fluids mainly due to restricted access to its large volumes. In recent years, there is a growing interest for saliva analysis owing to the emergence of miniaturized sample preparation methods. The purpose of this paper is to review all microextraction methods and their principles of operation...
December 12, 2018: Bioanalysis
https://read.qxmd.com/read/30525928/juvenile-rat-and-pediatric-trazodone-studies-how-to-gain-extra-sensitivity-to-overcome-bioanalytical-challenges
#17
Silvana Olivieri, Graziella Bovi, Vanessa Petrucci, Anna Alfieri, Laura Oggianu, Rossella Picollo, Carolina Devastato, Patrizia Dragone, Fabio Garofolo, Serena Tongiani
AIM: Trazodone (TZD) is used for the treatment of depression in adults and, off-label, as a sleep medication in adult and pediatric populations. The off-label use is well documented, however further clinical studies are needed to confirm its efficacy and safety for the treatment of sleep disorders. In this scenario, we developed a bioanalytical method to quantify low TZD concentrations in samples collected by capillary microsampling (CMS) to support dose finding, Good Laboratory Practice juvenile rat toxicokinetic and upcoming pediatric studies...
December 10, 2018: Bioanalysis
https://read.qxmd.com/read/30488729/2018-white-paper-on-recent-issues-in-bioanalysis-focus-on-immunogenicity-assays-by-hybrid-lba-lcms-and-regulatory-feedback-part-2-pk-pd-ada-assays-by-hybrid-lba-lcms-regulatory-agencies-inputs-on-bioanalysis-biomarkers-and-immunogenicity
#18
Hendrik Neubert, Timothy Olah, Anita Lee, Stephanie Fraser, Robert Dodge, Omar Laterza, Matthew Szapacs, Stephen C Alley, Ola M Saad, Shashi Amur, Linzhi Chen, Elana Cherry, Seongeun Julia Cho, Isabelle Cludts, Lorella Di Donato, Anna Edmison, Luca Ferrari, Fabio Garofolo, Sam Haidar, Shirley Hopper, Scott Hottenstein, Akiko Ishii-Watabe, Sean Kassim, Pekka Kurki, Gustavo Mendes Lima Santos, Gilles Miscoria, Joe Palandra, João Pedras-Vasconcelos, Steven Piccoli, Sarah Rogstad, Yoshiro Saito, Natasha Savoie, Timothy Sikorski, Susan Spitz, Ludovicus Staelens, Daniela Verthelyi, Stephen Vinter, Meenu Wadhwa, Yow-Ming Wang, Jan Welink, Naidong Weng, Emma Whale, Eric Woolf, Jiang Wu, Haoheng Yan, Hongbin Yu, Shaolian Zhou
The 2018 12th Workshop on Recent Issues in Bioanalysis took place in Philadelphia, PA, USA on April 9-13, 2018 with an attendance of over 900 representatives from pharmaceutical/biopharmaceutical companies, biotechnology companies, contract research organizations and regulatory agencies worldwide. WRIB was once again a 5-day, week-long event - a full immersion week of bioanalysis, biomarkers and immunogenicity. As usual, it was specifically designed to facilitate sharing, reviewing, discussing and agreeing on approaches to address the most current issues of interest including both small- and large-molecule bioanalysis involving LCMS, hybrid LBA/LCMS and LBA/cell-based assays approaches...
November 29, 2018: Bioanalysis
https://read.qxmd.com/read/30488726/2018-white-paper-on-recent-issues-in-bioanalysis-focus-on-flow-cytometry-gene-therapy-cut-points-and-key-clarifications-on-bav-part-3-lba-cell-based-assays-immunogenicity-biomarkers-and-pk-assays
#19
Lauren Stevenson, Susan Richards, Renuka Pillutla, Albert Torri, John Kamerud, Devangi Mehta, Stephen Keller, Shobha Purushothama, Boris Gorovits, Virginia Litwin, Christopher Stebbins, Joseph Marini, Chris Beaver, Gizette Sperinde, Patricia Siguenza, Roland F Staack, Yongchang Qiu, Lakshmi Amaravadi, Shashi Amur, Catherine Aversa Fleener, Daniel Baltrukonis, Ian Catlett, Elana Cherry, Shan Chung, Isabelle Cludts, Lorella Di Donato, Saloumeh Fischer, Stephanie Fraser, Fabio Garofolo, Cherie Green, George Gunn, Sam Haidar, Jonathan Haulenbeek, Neil Henderson, Shirley Hopper, Akiko Ishii-Watabe, Rafiq Islam, Brian Janelsins, Vibha Jawa, Vellalore Kakkanaiah, Szilard Kamondi, Gerry Kolaitis, Robert J Kubiak, Seema Kumar, Pekka Kurki, Meina Liang, Patrick Liu, Kimberly Maxfield, Heather Myler, Nisha Palackal, Rachel Palmer, João Pedras-Vasconcelos, Steven Piccoli, Paul Rhyne, Yoshiro Saito, Natasha Savoie, Eginhard Schick, Becky Schweighardt, Judy Shih, An Song, Priya Sriraman, Ludovicus Staelens, Giane Sumner, Yongliang Sun, Martin Ullmann, Daniela Verthelyi, Meenu Wadhwa, Yow-Ming Wang, Yuanxin Xu, Haoheng Yan, Tong-Yuan Yang, Rong Zeng
The 2018 12th Workshop on Recent Issues in Bioanalysis took place in Philadelphia, PA, USA on April 9-13, 2018 with an attendance of over 900 representatives from pharmaceutical/biopharmaceutical companies, biotechnology companies, contract research organizations and regulatory agencies worldwide. WRIB was once again a 5-day full immersion in bioanalysis, biomarkers and immunogenicity. As usual, it was specifically designed to facilitate sharing, reviewing, discussing and agreeing on approaches to address the most current issues of interest including both small- and large-molecule bioanalysis involving LCMS, hybrid LBA/LCMS and LBA/cell-based assays approaches...
November 29, 2018: Bioanalysis
https://read.qxmd.com/read/30488725/2018-white-paper-on-recent-issues-in-bioanalysis-a-global-bioanalytical-community-perspective-on-last-decade-of-incurred-samples-reanalysis-isr-part-1-small-molecule-regulated-bioanalysis-small-molecule-biomarkers-peptides-oligonucleotide-bioanalysis
#20
Jan Welink, Yuanxin Xu, Eric Yang, Amanda Wilson, Neil Henderson, Lina Luo, Stephanie Fraser, Uma Kavita, Adrien Musuku, Christopher James, Daniela Fraier, Yan Zhang, Dina Goykhman, Scott Summerfield, Eric Woolf, Tom Verhaeghe, Nicola Hughes, Alexander Behling, Kirk Brown, Alex Bulychev, Michael Buonarati, Elana Cherry, Seongeun Julia Cho, Isabelle Cludts, Lieve Dillen, Robert Dodge, Anna Edmison, Fabio Garofolo, Rachel Green, Sam Haidar, Charles Hottenstein, Akiko Ishii-Watabe, Hyun Gyung Jang, Allena Ji, Barry Jones, Sean Kassim, Mark Ma, Gustavo Mendes Lima Santos, Daniel A Norris, Tate Owen, Steven Piccoli, Ragu Ramanathan, Ingo Röhl, Anton I Rosenbaum, Yoshiro Saito, Timothy Sangster, Natasha Savoie, Christopher Stebbins, Jens Sydor, Nico van de Merbel, Daniela Verthelyi, Stephen Vinter, Emma Whale
The 2018 12th Workshop on Recent Issues in Bioanalysis (12th WRIB) took place in Philadelphia, PA, USA on April 9-13, 2018 with an attendance of over 900 representatives from pharmaceutical/biopharmaceutical companies, biotechnology companies, contract research organizations and regulatory agencies worldwide. WRIB was once again a 5-day full immersion in bioanalysis, biomarkers and immunogenicity. As usual, it was specifically designed to facilitate sharing, reviewing, discussing and agreeing on approaches to address the most current issues of interest including both small- and large-molecule bioanalysis involving LC-MS, hybrid ligand binding assay (LBA)/LC-MS and LBA/cell-based assays approaches...
November 29, 2018: Bioanalysis
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