Journal articles: 'Regulated bioanalysis'

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Igarashi, Harue. "6th Japan Bioanalysis Forum Symposium: challenge of regulated bioanalysis." Bioanalysis 7, no. 14 (2015): 1711–15. http://dx.doi.org/10.4155/bio.15.102.

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Nakamura, Takahiro. "7th Japan Bioanalysis Forum symposium: regulated bioanalysis, to a new stage." Bioanalysis 8, no. 20 (2016): 2097–102. http://dx.doi.org/10.4155/bio-2016-4995.

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Unger, Steve, Thomas Horvath, Melvin Tan, et al. "Making methods rugged for regulated bioanalysis." Bioanalysis 7, no. 7 (2015): 833–52. http://dx.doi.org/10.4155/bio.14.317.

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Jin, Fan, Daniel Tang, Kelly Dong, and Dafang Zhong. "The 7th China Bioanalysis Forum Annual Meeting." Bioanalysis 12, no. 2 (2020): 71–74. http://dx.doi.org/10.4155/bio-2019-0287.

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This article summarizes the highlights from the 7th China Bioanalysis Forum (CBF) Annual Conference in June 2019. The annual CBF conference provided a great platform for the Chinese bioanalytical community to discuss the current bioanalytical regulations, share challenges and experiences. With rapid growth of the pharma industry in China in the past decade and advancement in regulatory reform, the overall science and quality of regulated bioanalysis have now reached international standards. The CBF continues its efforts in promoting scientific excellence, quality and regulatory compliance in China and facilitating close collaboration with the international bioanalysis community.

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Garofolo, Fabio, Natasha Savoie, Annik Bergeron, et al. "Importance of metabolite testing in regulated bioanalysis." Bioanalysis 2, no. 7 (2010): 1171–74. http://dx.doi.org/10.4155/bio.10.15.

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Freisleben, Achim, Margarete Brudny-Klöppel, Hans Mulder, Ronald de Vries, Marcel de Zwart, and Philip Timmerman. "Blood stability testing: European Bioanalysis Forum view on current challenges for regulated bioanalysis." Bioanalysis 3, no. 12 (2011): 1333–36. http://dx.doi.org/10.4155/bio.11.121.

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Arfvidsson, Cecilia, David Van Bedaf, Susanne Globig, et al. "Improving data integrity in regulated bioanalysis: proposal for a generic data transfer process for LC–MS from the European Bioanalysis Forum." Bioanalysis 12, no. 14 (2020): 1033–38. http://dx.doi.org/10.4155/bio-2020-0156.

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In this paper, the European Bioanalysis Forum reports back from the discussions with software developers, involved in regulated bioanalysis software solutions, on agreeing to data transfer specification in the bioanalytical labs’ LC–MS workflows as part of today’s Data Integrity (DI) challenges. The proposed specifications aim at identifying what consists of a minimum dataset, that is, which are the pre-identified fields to be included in DI proof bidirectional data transfer between LC–MS and information management systems. The proposal is an attempt from the European Bioanalysis Forum to facilitate new software solutions becoming available to increase compliance related to DI in today’s LC–MS workflows. The proposal may also serve as a template and inspiration for new data transfer solutions in other workflows.

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Ramanathan, Vikram K., and Nimish N. Vachharajani. "Regulated bioanalysis: an Indian perspective on harmonization efforts." Bioanalysis 3, no. 7 (2011): 713–16. http://dx.doi.org/10.4155/bio.11.14.

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De Vooght-Johnson, Ryan. "Symposium Report: The Waters Bioanalysis World Tour: Insights into the Next Decade of Regulated Bioanalysis." Bioanalysis 3, no. 4 (2011): 369–82. http://dx.doi.org/10.4155/bio.10.218.

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Dong, Kelly. "Perspectives on the draft ICH M10 guidance: an interview with Kelly Dong." Bioanalysis 11, no. 22 (2019): 2025–26. http://dx.doi.org/10.4155/bio-2019-0255.

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Kelly Dong, PhD, Chief Executive Officer, United-Power Pharma Tech Co., Ltd Kelly Dong obtained her PhD degree from McGill University, Canada. Kelly has nearly 25 years of multinational industry experience working for pharmaceutical companies and CROs in Canada, the UK and China. Her scientific expertise encompasses drug metabolism and pharmacokinetics (DMPK) in drug discovery and regulated bioanalysis for preclinical and clinical development. After 20-year overseas experience, she joined GlaxoSmithKline R&D China in August 2009. She was the Director of DMPK for CNS drug discovery and Head of Bioanalysis, Immunogenicity and Biomarkers, overseeing more than 40 preclinical and clinical studies across different therapeutic areas. She joined United-Power Pharma as the Chief Executive Officer in February 2018. She is also a research fellow at the National Engineering Research Center of Protein Drugs. She is one of the founders and a steering committee member of China Bioanalysis Forum. She is also an active contributor to the scientific community, with numerous scientific publications, invited presentations and organizing scientific conferences. This interview was conducted by Sankeetha Nadarajah, Managing Commissioning Editor of Bioanalysis.

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J Woolf, Eric. "Perspectives on the draft ICH-M10 guidance: an interview with Eric J Woolf." Bioanalysis 11, no. 15 (2019): 1387–88. http://dx.doi.org/10.4155/bio-2019-0178.

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Biography Dr Woolf is currently Executive Director of the regulated PK Bioanalysis Group of Merck Research Laboratories, West Point, PA, USA. He received his BA in Chemistry from LaSalle College in 1982, and a PhD in Analytical Chemistry from Seton Hall University in 1986. From 1986 to 1990, he was a member of the Drug Metabolism/Pharmacokinetics Department of Berlex Laboratories. He joined Merck Research Laboratories in 1990 as a research fellow. Dr Woolf and his group have supported numerous clinical development projects that have led to the successful registration of Merck compounds. Since 1986, he has authored or coauthored over 50 research papers pertaining to bioanalysis and pharmacokinetics. This interview was conducted by Sankeetha Nadarajah, Managing Commissioning Editor of Bioanalysis, at the AAPS ICH-M10 Public Consultation Workshop (Silver Spring, MD, USA), 11 June 2019.

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Fu, Yunlin, Deborah Barkley, Wenkui Li, Franck Picard, and Jimmy Flarakos. "Evaluation, identification and impact assessment of abnormal internal standard response variability in regulated LC−MS bioanalysis." Bioanalysis 12, no. 8 (2020): 545–59. http://dx.doi.org/10.4155/bio-2020-0058.

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Internal standard (IS) plays an important role in LC−MS bioanalysis by compensating for the variability of the analyte of interest in bioanalytical workflow. Due to the complexity of biological sample compositions and bioanalytical processes, a certain level of IS response variability across a run or a study is anticipated. However, an extensive variability may raise doubts to the accuracy of the measured results and also suggest nonoptimal analytical method. In this current paper, recent publications and guidelines regarding IS response in LC−MS bioanalysis were thoroughly reviewed with focus on the evaluation, identification and impact assessment of ‘abnormal’ IS response variability. A systematic decision tree was proposed to facilitate investigation into abnormal IS response variability after each run.

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Zhang, Xueyuan, Yuhuan Ji, Jinzhi Liu, et al. "Regulated bioanalysis of liposomal amphotericin B to support pharmacokinetic studies of liposomal drugs." Bioanalysis 14, no. 7 (2022): 421–39. http://dx.doi.org/10.4155/bio-2021-0281.

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Background: Because of the delicate nature of liposomes, bioanalysis of free and liposomal-encapsulated drugs is among the most challenging assays to perform. Current regulatory guidance for bioanalysis is not sufficient to address the complexity of this particular formulation. Method & results: Three individual LC–MS/MS methods to quantify free amphotericin B (10–3000 ng/ml) and encapsulated amphotericin B (100–50,000 ng/ml) in pretreated human plasma and total amphotericin B (100–50,000 ng/ml) in human plasma were fully validated and applied to a bioequivalence study. The acceptance criteria and experimental design of additional validation tests using cross quality control were carefully deliberated a priori and included in the sample analysis as well. Discussion: Additional validation tests are necessary to demonstrate that the measured concentration of the intended component is accurate and free of interference from other coexisting components in the sample. These practices can be used as guidance for future liposomal drug method validation.

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Timmerman, Philip, Neil Henderson, John Smeraglia, et al. "Managing scientific, technical and regulatory innovation in regulated bioanalysis: a discussion paper from the European Bioanalysis Forum." Bioanalysis 5, no. 2 (2013): 139–45. http://dx.doi.org/10.4155/bio.12.267.

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Tang, Daniel, and Dafang Zhong. "Regulated bioanalysis and the desire for harmonized regulations in China." Bioanalysis 2, no. 12 (2010): 1913–19. http://dx.doi.org/10.4155/bio.10.166.

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Bérubé, Eugénie-Raphaëlle, Marie-Pierre Taillon, Milton Furtado, and Fabio Garofolo. "Impact of sample hemolysis on drug stability in regulated bioanalysis." Bioanalysis 3, no. 18 (2011): 2097–105. http://dx.doi.org/10.4155/bio.11.190.

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Huang, Yong, Robert Shi, Winnie Gee, and Richard Bonderud. "Matrix effect and recovery terminology issues in regulated drug bioanalysis." Bioanalysis 4, no. 3 (2012): 271–79. http://dx.doi.org/10.4155/bio.11.315.

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Unger, Steve, Thomas Lloyd, Melvin Tan, Jingguo Hou, and Edward Wells. "The science of laboratory and project management in regulated bioanalysis." Bioanalysis 6, no. 10 (2014): 1357–72. http://dx.doi.org/10.4155/bio.14.89.

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Jenkins, Rand G. "Accuracy: a potential quandary in regulated bioanalysis of ‘endogenous’ analytes." Bioanalysis 8, no. 23 (2016): 2393–97. http://dx.doi.org/10.4155/bio-2016-0247.

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Barfield, Matthew, Joanne Goodman, John Hood, and Philip Timmerman. "European Bioanalysis Forum recommendation on singlicate analysis for ligand binding assays: time for a new mindset." Bioanalysis 12, no. 5 (2020): 273–84. http://dx.doi.org/10.4155/bio-2019-0298.

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It is well accepted that chromatographic assay methods employ singlicate analysis for toxicokinetic and pharmacokinetic analysis. While conversely, it has been the norm for ligand-binding assays to be run in at least duplicate analyses, stemming mainly from concerns over inherent assay variability and reagent quality. Regulatory guidelines and guidance on bioanalytical method validation has, in the most part, recommended multiple replicates for immunoassays and this has led to the industry being comfortable and familiar with duplicate analysis. Over the last few years, the discussion on whether singlicate analysis is acceptable for ligand-binding assays has grown and the status quo is being challenged for regulated bioanalysis performed using immunoassays. Through interrogation of preclinical and clinical pharmacokinetic assay data from the European Bioanalysis Forum community, the application of a singlicate analysis strategy has shown to have no impact on toxicokinetic and pharmacokinetic parameters when compared with duplicate analysis from the same studies. Therefore, now is the time to adopt a new mindset when it comes to sample analysis for toxicokinetic and pharmacokinetic ligand-binding assays and embrace singlicate analysis in the regulated environment.

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Timmerman, Philip, Joanne Goodman, Michaela Golob, et al. "European Bioanalysis Forum feedback on draft ICH M10 guideline on bioanalytical method validation during the Step 2b public consultation period." Bioanalysis 12, no. 6s (2020): 1–11. http://dx.doi.org/10.4155/bio-2020-0065.

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Once released, the ICH M10 Guideline on bioanalytical method validation will become one of the most important milestones in the history of regulated bioanalysis, closing a chapter on intense discussions among the industry and health authorities started in Crystal City in 2001. In this manuscript, the European Bioanalysis Forum community reports back on their feedback on the ICH M10 draft guideline gathered during the public consultation period. The comments given are intended to contribute to a guideline that combines several decades of experience and current scientific vision. They should provide future generations of bioanalytical scientist a regulatory framework so their bioanalytical work can contribute to safe, effective and high-quality medicines, which can be developed and registered in the most resource-efficient manner.

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Ledvina, Aaron R., Matthew Ewles, Yongle Pang, and Stephanie Cape. "Whole blood stability in quantitative bioanalysis." Bioanalysis 11, no. 20 (2019): 1885–97. http://dx.doi.org/10.4155/bio-2019-0155.

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Establishing stability at all stages of a sample’s lifespan is a critical part of performing regulated bioanalysis. For plasma assays, this includes the duration between when blood is drawn and when that blood is centrifuged to produce plasma. Here, we provide a discussion of current regulatory expectations around whole blood stability testing for LC–MS plasma assays, as well as the two primary experimental approaches utilized to assess whole blood stability. Next, we interrogated a large dataset of validated methods (1076 methods, the vast majority of which were for measurement of small molecules) to assess the correlation between whole blood and plasma stability profiles, finding them to be highly correlated. Finally, we summarize unique case studies; we have encountered during WB stability testing which offer lessons that may be broadly applicable.

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Arfvidsson, Cecilia, David Van Bedaf, Mira Doig, et al. "Data integrity in regulated bioanalysis: a summary from the European Bioanalysis Forum Workshop in collaboration with the MHRA." Bioanalysis 11, no. 13 (2019): 1227–31. http://dx.doi.org/10.4155/bio-2019-0139.

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In this conference report, we summarize the main findings and messages from a workshop on ‘Data Integrity’. The workshop was held at the 11th European Bioanalysis Forum Open (EBF) Symposium in Barcelona (21–23 November 2018), in collaboration with the Medicines and Health products Regulatory Agency to provide insight and understanding of regulatory data integrity expectations. The workshop highlighted the importance of engaging with software developers to address the gap between industry’s data integrity needs and current system software capabilities. Delegates were also made aware of the importance of implementing additional procedural controls to mitigate the risk associated with using systems that do not fully meet data integrity requirements.

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Huang, Yong, Robert Shi, Winnie Gee, and Richard Bonderud. "Regulated drug bioanalysis for human pharmacokinetic studies and therapeutic drug management." Bioanalysis 4, no. 15 (2012): 1919–31. http://dx.doi.org/10.4155/bio.12.157.

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Wang, Laixin, Min Meng, and Scott Reuschel. "Regulated bioanalysis of oligonucleotide therapeutics and biomarkers: qPCR versus chromatographic assays." Bioanalysis 5, no. 22 (2013): 2747–51. http://dx.doi.org/10.4155/bio.13.234.

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Tan, Aimin, Kayode Awaiye, and Fethi Trabelsi. "Some unnecessary or inadequate common practices in regulated LC–MS bioanalysis." Bioanalysis 6, no. 20 (2014): 2751–65. http://dx.doi.org/10.4155/bio.14.198.

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Tavares-Neto, João, and Camila Fracalossi Rediguieri. "Regulated bioanalysis in Brazil: is the country ready to move on?" Bioanalysis 6, no. 11 (2014): 1417–19. http://dx.doi.org/10.4155/bio.14.70.

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Chang, Min S., Elaine J. Kim, and Tawakol A. El-Shourbagy. "Evaluation of 384-well formatted sample preparation technologies for regulated bioanalysis." Rapid Communications in Mass Spectrometry 21, no. 1 (2006): 64–72. http://dx.doi.org/10.1002/rcm.2808.

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Henderson, Neil, and Amanda Wilson. "Measurement of mRNA therapeutics: method development and validation challenges." Bioanalysis 11, no. 21 (2019): 2003–10. http://dx.doi.org/10.4155/bio-2019-0120.

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The progression of chemically modified mRNA therapeutics through development pipelines is accelerating for many disease indications and the need to assess these analytes is becoming more routine for the pharmaceutical industry and contract research organizations. This article describes some of the challenges and strategies for performing regulated bioanalysis of modified mRNA therapeutics by comparing the two main analytical approaches – quantitative reverse transcription PCR and branched DNA.

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Davis, Scott, Shibani Mitra-Kaushik, Eric Woolf, et al. "Cloud security in a bioanalytical world: considerations for use of third-party cloud services for bioanalysis." Bioanalysis 15, no. 24 (2023): 1461–68. http://dx.doi.org/10.4155/bio-2023-0164.

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While using the cloud environment for various functions has become commonplace, relatively little attention has been given to considerations for the use of third-party cloud services for regulated bioanalytical workflow and data management. Little guidance has been provided as to how to utilize the cloud to support bioanalytical activities. It can be intimidating when considering how to go about using cloud services for data acquisition, but there are some general ideas to keep in mind when evaluating ways to accommodate regulated bioanalysis online. Determining how to incorporate the use of cloud storage with data that are generated from regulated bioanalytical analysis is an important step in maintaining the security of the data.

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Kaur, Surinder, Stephen C. Alley, Matt Szapacs, et al. "2021 White Paper on Recent Issues in Bioanalysis: Mass Spec of Proteins, Extracellular Vesicles, CRISPR, Chiral Assays, Oligos; Nanomedicines Bioanalysis; ICH M10 Section 7.1; Non-Liquid & Rare Matrices; Regulatory Inputs (Part 1A – Recommendations on Endogenous Compounds, Small Molecules, Complex Methods, Regulated Mass Spec of Large Molecules, Small Molecule, PoC & Part 1B - Regulatory Agencies' Inputs on Bioanalysis, Biomarkers, Immunogenicity, Gene & Cell Therapy and Vaccine)." Bioanalysis 14, no. 9 (2022): 505–80. http://dx.doi.org/10.4155/bio-2022-0078.

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The 15th edition of the Workshop on Recent Issues in Bioanalysis (15th WRIB) was held on 27 September to 1 October 2021. Even with a last-minute move from in-person to virtual, an overwhelmingly high number of nearly 900 professionals representing pharma and biotech companies, contract research organizations (CROs), and multiple regulatory agencies still eagerly convened to actively discuss the most current topics of interest in bioanalysis. The 15th WRIB included 3 Main Workshops and 7 Specialized Workshops that together spanned 1 week in order to allow exhaustive and thorough coverage of all major issues in bioanalysis, biomarkers, immunogenicity, gene therapy, cell therapy and vaccines. Moreover, in-depth workshops on biomarker assay development and validation (BAV) (focused on clarifying the confusion created by the increased use of the term “Context of Use – COU”); mass spectrometry of proteins (therapeutic, biomarker and transgene); state-of-the-art cytometry innovation and validation; and, critical reagent and positive control generation were the special features of the 15th edition. This 2021 White Paper encompasses recommendations emerging from the extensive discussions held during the workshop, and is aimed to provide the bioanalytical community with key information and practical solutions on topics and issues addressed, in an effort to enable advances in scientific excellence, improved quality and better regulatory compliance. Due to its length, the 2021 edition of this comprehensive White Paper has been divided into three parts for editorial reasons. This publication (Part 1A) covers the recommendations on Endogenous Compounds, Small Molecules, Complex Methods, Regulated Mass Spec of Large Molecules, Small Molecule, PoC. Part 1B covers the Regulatory Agencies' Inputs on Bioanalysis, Biomarkers, Immunogenicity, Gene & Cell Therapy and Vaccine. Part 2 (ISR for Biomarkers, Liquid Biopsies, Spectral Cytometry, Inhalation/Oral & Multispecific Biotherapeutics, Accuracy/LLOQ for Flow Cytometry) and Part 3 (TAb/NAb, Viral Vector CDx, Shedding Assays; CRISPR/Cas9 & CAR-T Immunogenicity; PCR & Vaccine Assay Performance; ADA Assay Comparabil ity & Cut Point Appropriateness) are published in volume 14 of Bioanalysis, issues 10 and 11 (2022), respectively.

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Spitz, Susan, Yan Zhang, Sally Fischer, et al. "2020 White Paper on Recent Issues in Bioanalysis: BAV Guidance, CLSI H62, Biotherapeutics Stability, Parallelism Testing, CyTOF and Regulatory Feedback (Part 2A – Recommendations on Biotherapeutics Stability, PK LBA Regulated Bioanalysis, Biomarkers Assays, Cytometry Validation & Innovation Part 2B – Regulatory Agencies’ Inputs on Bioanalysis, Biomarkers, Immunogenicity, Gene & Cell Therapy and Vaccine)." Bioanalysis 13, no. 5 (2021): 295–361. http://dx.doi.org/10.4155/bio-2021-0005.

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The 14th edition of the Workshop on Recent Issues in Bioanalysis (14th WRIB) was held virtually on June 15-29, 2020 with an attendance of over 1000 representatives from pharmaceutical/biopharmaceutical companies, biotechnology companies, contract research organizations, and regulatory agencies worldwide. The 14th WRIB included three Main Workshops, seven Specialized Workshops that together spanned 11 days in order to allow exhaustive and thorough coverage of all major issues in bioanalysis, biomarkers, immunogenicity, gene therapy and vaccine. Moreover, a comprehensive vaccine assays track; an enhanced cytometry track and updated Industry/Regulators consensus on BMV of biotherapeutics by LCMS were special features in 2020. As in previous years, this year's WRIB continued to gather a wide diversity of international industry opinion leaders and regulatory authority experts working on both small and large molecules to facilitate sharing and discussions focused on improving quality, increasing regulatory compliance and achieving scientific excellence on bioanalytical issues. This 2020 White Paper encompasses recommendations emerging from the extensive discussions held during the workshop, and is aimed to provide the Global Bioanalytical Community with key information and practical solutions on topics and issues addressed, in an effort to enable advances in scientific excellence, improved quality and better regulatory compliance. Due to its length, the 2020 edition of this comprehensive White Paper has been divided into three parts for editorial reasons. This publication covers the recommendations on (Part 2A) BAV, PK LBA, Flow Cytometry Validation and Cytometry Innovation and (Part 2B) Regulatory Input. Part 1 (Innovation in Small Molecules, Hybrid LBA/LCMS & Regulated Bioanalysis), Part 3 (Vaccine, Gene/Cell Therapy, NAb Harmonization and Immunogenicity) are published in volume 13 of Bioanalysis, issues 4, and 6 (2021), respectively.

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Corsaro, Bart, Tong-yuan Yang, Rocio Murphy, et al. "2020 White Paper on Recent Issues in Bioanalysis: Vaccine Assay Validation, qPCR Assay Validation, QC for CAR-T Flow Cytometry, NAb Assay Harmonization and ELISpot Validation (Part 3 – Recommendations on Immunogenicity Assay Strategies, NAb Assays, Biosimilars and FDA/EMA Immunogenicity Guidance/Guideline, Gene & Cell Therapy and Vaccine Assays)." Bioanalysis 13, no. 6 (2021): 415–63. http://dx.doi.org/10.4155/bio-2021-0007.

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The 14th edition of the Workshop on Recent Issues in Bioanalysis (14th WRIB) was held virtually on June 15-29, 2020 with an attendance of over 1000 representatives from pharmaceutical/biopharmaceutical companies, biotechnology companies, contract research organizations, and regulatory agencies worldwide. The 14th WRIB included three Main Workshops, seven Specialized Workshops that together spanned 11 days in order to allow exhaustive and thorough coverage of all major issues in bioanalysis, biomarkers, immunogenicity, gene therapy and vaccine. Moreover, a comprehensive vaccine assays track; an enhanced cytometry track and updated Industry/Regulators consensus on BMV of biotherapeutics by LCMS were special features in 2020. As in previous years, this year's WRIB continued to gather a wide diversity of international industry opinion leaders and regulatory authority experts working on both small and large molecules to facilitate sharing and discussions focused on improving quality, increasing regulatory compliance and achieving scientific excellence on bioanalytical issues. This 2020 White Paper encompasses recommendations emerging from the extensive discussions held during the workshop and is aimed to provide the Global Bioanalytical Community with key information and practical solutions on topics and issues addressed, in an effort to enable advances in scientific excellence, improved quality and better regulatory compliance. Due to its length, the 2020 edition of this comprehensive White Paper has been divided into three parts for editorial reasons. This publication (Part 3) covers the recommendations on Vaccine, Gene/Cell Therapy, NAb Harmonization and Immunogenicity). Part 1 (Innovation in Small Molecules, Hybrid LBA/LCMS & Regulated Bioanalysis), Part 2A (BAV, PK LBA, Flow Cytometry Validation and Cytometry Innovation) and Part 2B (Regulatory Input) are published in volume 13 of Bioanalysis, issues 4 and 5 (2020), respectively.

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Tang, Daniel, and Elizabeth Thomas. "Strategies for dealing with hemolyzed samples in regulated LC–MS/MS bioanalysis." Bioanalysis 4, no. 22 (2012): 2715–24. http://dx.doi.org/10.4155/bio.12.229.

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Neubert, Hendrik, Stephen C. Alley, Anita Lee, et al. "2020 White Paper on Recent Issues in Bioanalysis: BMV of Hybrid Assays, Acoustic MS, HRMS, Data Integrity, Endogenous Compounds, Microsampling and Microbiome (Part 1 – Recommendations on Industry/Regulators Consensus on BMV of Biotherapeutics by LCMS, Advanced Application in Hybrid Assays, Regulatory Challenges in Mass Spec, Innovation in Small Molecules, Peptides and Oligos)." Bioanalysis 13, no. 4 (2021): 203–38. http://dx.doi.org/10.4155/bio-2020-0324.

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The 14th edition of the Workshop on Recent Issues in Bioanalysis (14th WRIB) was held virtually on June 15–29, 2020 with an attendance of over 1000 representatives from pharmaceutical/biopharmaceutical companies, biotechnology companies, contract research organizations, and regulatory agencies worldwide. The 14th WRIB included three Main Workshops, seven Specialized Workshops that together spanned 11 days in order to allow exhaustive and thorough coverage of all major issues in bioanalysis, biomarkers, immunogenicity, gene therapy, cell therapy and vaccine. Moreover, a comprehensive vaccine assays track; an enhanced cytometry track and updated Industry/Regulators consensus on BMV of biotherapeutics by Mass Spectrometry (hybrid assays, LCMS and HRMS) were special features in 2020. As in previous years, this year's WRIB continued to gather a wide diversity of international industry opinion leaders and regulatory authority experts working on both small and large molecules to facilitate sharing and discussions focused on improving quality, increasing regulatory compliance and achieving scientific excellence on bioanalytical issues. This 2020 White Paper encompasses recommendations emerging from the extensive discussions held during the workshop and is aimed to provide the Global Bioanalytical Community with key information and practical solutions on topics and issues addressed, in an effort to enable advances in scientific excellence, improved quality and better regulatory compliance. Due to its length, the 2020 edition of this comprehensive White Paper has been divided into three parts for editorial reasons. This publication covers the recommendations on (Part 1) Hybrid Assays, Innovation in Small Molecules, & Regulated Bioanalysis. Part 2A (BAV, PK LBA, Flow Cytometry Validation and Cytometry Innovation), Part 2B (Regulatory Input) and Part 3 (Vaccine, Gene/Cell Therapy, NAb Harmonization and Immunogenicity) are published in volume 13 of Bioanalysis, issues 5, and 6 (2021), respectively.

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Bowsher, Ronald R., and William L. Nowatzke. "Insights in regulated bioanalysis of human insulin and insulin analogs by immunoanalytical methods." Bioanalysis 3, no. 8 (2011): 883–98. http://dx.doi.org/10.4155/bio.11.50.

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Heinig, Katja, Elke Zwanziger, and Dieter Zimmer. "What are the challenges of stability investigations and sample stabilization in regulated bioanalysis?" Bioanalysis 5, no. 15 (2013): 1811–14. http://dx.doi.org/10.4155/bio.13.157.

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Guo, Yuchun, Jiangtao Ren, and Erkang Wang. "Implementation of logic operations and bioanalysis based on DNA allostery-regulated nanometallic catalysis." Nano Today 44 (June 2022): 101476. http://dx.doi.org/10.1016/j.nantod.2022.101476.

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Sydor, Jens, and Grace Kim. "Are we ready for the evolution of electronic laboratory notebooks in regulated bioanalysis?" Bioanalysis 9, no. 16 (2017): 1203–5. http://dx.doi.org/10.4155/bio-2017-0115.

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Birnboeck, Herbert F., Eginhard Schick, and Nicole Justies. "Singlicate analysis in regulated bioanalysis using ligand-binding assays: where are we heading?" Bioanalysis 9, no. 18 (2017): 1357–59. http://dx.doi.org/10.4155/bio-2017-0151.

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Bruijnsvoort, Michel van, John Meijer, and Cas van den Beld. "The application of control charts in regulated bioanalysis for monitoring long-term reproducibility." Bioanalysis 9, no. 24 (2017): 1955–65. http://dx.doi.org/10.4155/bio-2017-0163.

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Nakai, Keiko, Hiroshi Kamimori, Akemi Nagao, and Akira Nakayama. "Discussion on Partial Validation in Small Molecule Regulated Bioanalysis: Change in Analytical Instruments." YAKUGAKU ZASSHI 135, no. 11 (2015): 1317–24. http://dx.doi.org/10.1248/yakushi.15-00084.

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Kar, Sumit, and Clarinda Islam. "New approaches for biomarker stability determination in regulated bioanalysis: trending, bridging and incurred samples." Bioanalysis 11, no. 20 (2019): 1837–44. http://dx.doi.org/10.4155/bio-2019-0208.

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Aim: Determining the stability of biomarkers continues to present challenges. Disease states, complex matrices and differences between recombinant and endogenous analytes require new approaches to maintain stability and measure it. In this report, we determine stability for two assays using trending and statistical analysis. Methodology & results: Monitoring trends helps identify out of specification measurements and determine whether concerns are due to the stability of the analyte. We also describe challenges presented when measuring arginase activity in human sputum, a complex matrix, for respiratory diseases. We controlled preanalytical protease activity and collection heterogeneity and monitored incurred sample stability to improve stability of arginine. Conclusion: These new approaches to achieving and determining biomarker stability may provide solutions for increasingly complex biomarker measurements.

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Katori, Noriko. "Regulated bioanalysis in Japan: where do we come from and where are we going?" Bioanalysis 5, no. 11 (2013): 1321–23. http://dx.doi.org/10.4155/bio.13.71.

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Liu, Rong, Brian Hoffpauir, Shannon D. Chilewski, et al. "Accelerating Regulated Bioanalysis for Biotherapeutics: Case Examples Using a Microfluidic Ligand Binding Assay Platform." AAPS Journal 19, no. 1 (2016): 82–91. http://dx.doi.org/10.1208/s12248-016-0006-z.

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Ohtsu, Yoshiaki, Shohei Otsuka, Takeshi Nakamura, and Kiyoshi Noguchi. "Regulated bioanalysis of conformers – A case study with ASP2151 in dog plasma and urine." Journal of Chromatography B 997 (August 2015): 56–63. http://dx.doi.org/10.1016/j.jchromb.2015.05.028.

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Welink, Jan, Yuanxin Xu, Eric Yang, et al. "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)." Bioanalysis 10, no. 22 (2018): 1781–801. http://dx.doi.org/10.4155/bio-2018-0268.

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Wright, Michael J., Robert Wheller, Geoff Wallace, and Rachel Green. "Internal standards in regulated bioanalysis: putting in place a decision-making process during method development." Bioanalysis 11, no. 18 (2019): 1701–13. http://dx.doi.org/10.4155/bio-2019-0169.

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Abstract:

It is common practice to utilize an internal standard (IS) to minimize variance in bioanalytical assays employing liquid chromatography coupled to mass spectrometry. For assays to be deployed in regulated drug development studies, ensuring the IS will compensate for differences in recovery, liquid handling and ionization efficiency should be determined early in the method development process. In this perspective article, we outline key considerations when selecting an IS and propose experiments to perform within the method development phase to demonstrate suitability of the IS within the assay prior to validation. Finally, a series of case studies will be presented, which illustrate analytical challenges related to internal standardization that we have observed in our laboratory.

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Savoie, Natasha, Fabio Garofolo, Peter van Amsterdam, et al. "2010 White Paper on Recent Issues in Regulated Bioanalysis & Global Harmonization of Bioanalytical Guidance." Bioanalysis 2, no. 12 (2010): 1945–60. http://dx.doi.org/10.4155/bio.10.164.

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Dijksman, Jessica, Neil Henderson, Benno Ingelse, et al. "Conference Report: The 3rd EBF Focus Meeting: ‘Hatching’ – emerging technologies approaching the regulated bioanalysis laboratory." Bioanalysis 4, no. 23 (2012): 2769–74. http://dx.doi.org/10.4155/bio.12.273.

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Journal articles on the topic 'Regulated bioanalysis'

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