2010 White Paper on Recent Issues in Regulated Bioanalysis &amp; Global Harmonization of Bioanalytical Guidance

Savoie, Natasha; Garofolo, Fabio; Amsterdam, Peter van; Bansal, Surendra K.; Beaver, Chris; Bedford, Patrick; Booth, Brian; Evans, Christopher A.; Jemal, Mohammed; Lefebvre, Marc; Silva, Arthur Leonardo Lopes de; Lowes, Steve; Marini, Joseph C.; Massé, Robert; Mawer, Louise; Ormsby, Eric; Rocci, Mario L.; Viswanathan, C. T.; Wakelin-Smith, Jason; Welink, Jan; White, Joleen T.; Woolf, Eric

doi:10.4155/bio.10.164

Cited by 121 publications

(53 citation statements)

References 17 publications

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“…Following extensive input from industry experts, no examples were provided where analyte stability was affected by co-administered compounds, thus, bringing into question the scientific rationale for such stability assessment requirements [4]. Discussions continued in 2011 and 2014, in an effort to determine the scientific needs of performing co-administered stability tests.…”

Section: Co-administered Compound Stabilitymentioning

confidence: 99%

“…In 2010, the consensus was reached that global harmonization of bioanalytical guidance is an important and necessary step in facilitating global submissions of studies supporting the release of new drugs. There was a call supported by US FDA at the 2010 WRIB to create an all-inclusive Global Bioanalytical Consortium with representation from scientific associations worldwide to discuss harmonization of bioanalytical regulatory guidance and ideally propose unified guidance language that can be presented to regional agencies [4]. This group was created and a consensus was attained at the 2011 WRIB and resultant White Paper: the pursuit of consistency among regulatory inspectors can be facilitated via appropriate training, meetings and constructive exchanges among countries [5].…”

Section: Global Bioanalytical Consortium and Global Harmonization Of Bmmentioning

confidence: 99%

“…In 2010, carryover was discussed in detail and it was agreed that carryover must be investigated during method development, and minimized [4]. The most common procedure used by the industry is to inject a blank or zero sample after an upper limit of quantitation (ULQ) sample, or multiple ULQ samples.…”

Section: Carryover (Lcms)mentioning

confidence: 99%

“…The use of either bulk or fresh preparations of calibration standards can be used during sample analysis, with proper supporting stability data, if necessary [4]. However, when performing stability evaluations, a 'fresh' curve preparation means freshly fortified calibration standards only, while QC samples may not need to be freshly f ortified since subject samples are generally frozen at least once and thawed [5].…”

Section: Calibration Curvesmentioning

confidence: 99%

“…The attendees recommended that the following categories be used to denote the level of validation achieved: screening, qualified and validated. All levels of validation should be scientifically justified a priori based on the intended use of the data [4]. The subject was discussed again in 2011, and the recommendation at that time was a confirmation and extension of the year before: all studies destined for submission to regulatory agencies should be performed with analytical methods that are fully validated as per existing validation guidance/guideline, while for other studies, a 'fit-for-purpose' approach may be deemed acceptable [5].…”

Section: Fit-for-purpose Validation (Biomarkers Assays)mentioning

confidence: 99%

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The Decennial Index of The White Papers in Bioanalysis: ‘A Decade of Recommendations (2007–2016)’

Garofolo¹,

Savoie²

2017

Bioanalysis

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Each year, the Workshop on Recent Issues in Bioanalysis (WRIB) gathers a wide range of industry opinion leaders and regulatory authorities working on bioanalysis, biomarkers and immunogenicity to discuss the most current topics of interest, and to provide potential solutions aiming to improve quality, increase regulatory compliance and achieve scientific excellence.These yearly 'hot' topics (covering both small and large molecules), are the starting point for fruitful exchanges of knowledge, and extensive sharing of ideas among presenters, regulators and attendees, and are distilled into a series of relevant recommendations. The resultant White Papers summarizing these conclusions and consensus points from each WRIB provide the global bioanalytical community with key information and practical solutions on topics and issues addressed each year. This series of White Papers has always been among the 'most read' articles in Bioanalysis over the past 10 years [17].WRIB White Papers are designed to be 'horizontal' documents providing consensus on multiple topics rather than 'vertical' (i.e., 'consensus documents on a single topic for standardizing industry practice'). It is a cumulative effort spanning more than a year, with tremendous work behind the scenes by each co-author, starting from exhaustive preparation/design of each issue long before the WRIB, then extensive working-dinner discussions to prepare open panel discussions at the WRIB, and finally the refinement and critical review of the draft recommendations before turning it into a consensus paper.In recent years, to reflect the new structure of three sequential, core workshop days at WRIB, each White Paper has been divided into three parts to reflect the focus of each core workshop day: Part 1 on LCMS, Part 2 on hybrid ligand-binding assays (LBA)/LCMS and Regulatory Inputs and Part 3 on LBA.Although the recommendations presented in this article demonstrate that some topics have been extensively discussed repeatedly in the last decade, the evolution of bioanalysis, biomarkers and immunogenicity, and the accompanying technologies and regulations continue to bring additional challenges and solutions to existing problems. Continued assembly of industry and regulators will ensure that best practices continue in order to market safe and effective pharmaceutical products. The future publication of the 2017 White Paper in Bioanalysis signals the global bioanalytical community's intent to continue providing a consensus document for such discussions.After a decade of discussions and consensus, this article acts as a general index, organized by topic in alphabetic order, to easily consult all these recommendations and their evolution over time.

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Section: Co-administered Compound Stabilitymentioning

confidence: 99%

Section: Global Bioanalytical Consortium and Global Harmonization Of Bmmentioning

confidence: 99%

Section: Carryover (Lcms)mentioning

confidence: 99%

Section: Calibration Curvesmentioning

confidence: 99%

Section: Fit-for-purpose Validation (Biomarkers Assays)mentioning

confidence: 99%

See 3 more Smart Citations

The Decennial Index of The White Papers in Bioanalysis: ‘A Decade of Recommendations (2007–2016)’

Garofolo¹,

Savoie²

2017

Bioanalysis

Self Cite

View full text Add to dashboard Cite

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LC/MS versus Immune‐Based Bioanalytical Methods in Quantitation of Therapeutic Biologics in Biological Matrices

Zhang

2015

Pharmaceutical Sciences Encyclopedia

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This chapter reviews the main characteristics of liquid chromatography/mass spectrometry (LC/MS) and ligand‐binding assay (LBA) methods. If an LBA method for biotherapeutics quantification is well established, it usually provides sufficient sensitivity and selectivity and is considered the method of choice. The LC/MS method emerged as an alternative strategy for quantification of proteins of interest in complex biological matrices. Multiplexed capacity and selectivity are critical features determining the applicability of a bioanalytical method. Well‐established LBA methods usually provide adequate sensitivity for quantification analysis of biotherapeutics in preclinical/clinical pharmacokinetic (PK)/pharmacodynamic (PD) study. LC/MS with high resolution analyzer has become a promising technology for characterization of antibody‐drug conjugate (ADC) in the recent years. An affinity capture capillary LC coupled to quadrupole‐time‐of‐flight (TOF) MS has been employed to analyze anti‐MUC16 TDC, which obtained both in vitro and in vivo drug‐to‐antibody ratios (DARs) information.

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LC‐MS Bioanalysis of Drugs in Tissue Samples

Gao

Ho²,

Williams

2013

Handbook of LC‐MS Bioanalysis

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2010 White Paper on Recent Issues in Regulated Bioanalysis & Global Harmonization of Bioanalytical Guidance

Cited by 121 publications

References 17 publications

The Decennial Index of The White Papers in Bioanalysis: ‘A Decade of Recommendations (2007–2016)’

The Decennial Index of The White Papers in Bioanalysis: ‘A Decade of Recommendations (2007–2016)’

LC/MS versus Immune‐Based Bioanalytical Methods in Quantitation of Therapeutic Biologics in Biological Matrices

LC‐MS Bioanalysis of Drugs in Tissue Samples

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