Portal de Periódicos da CAPES

Building the Global Bioanalysis Consortium – working towards a functional globally acceptable and harmonized guideline on bioanalytical method validation

2010; Future Science Ltd; Volume: 2; Issue: 11 Linguagem: Inglês

10.4155/bio.10.146

1757-6199

Peter van Amsterdam, Mark E. Arnold, Surendra K. Bansal, Douglas M. Fast, Fabio Garofolo, Steve Lowes, Philip Timmerman, Eric Woolf,

Advanced Biosensing Techniques and Applications

BioanalysisVol. 2, No. 11 General content - EditorialFree AccessBuilding the Global Bioanalysis Consortium – working towards a functional globally acceptable and harmonized guideline on bioanalytical method validationPeter van Amsterdam, Mark Arnold, Surendra Bansal, Douglas Fast, Fabio Garofolo, Steve Lowes, Philip Timmerman & Eric WoolfPeter van Amsterdam† Author for correspondenceAbbott Healtcare Products BV, CJ van Houtenlaan 36, 1381 CP Weesp, The Netherlands. , Mark ArnoldBioanalytical Sciences, Bristol-Myers Squibb Co., NJ, USA, Surendra BansalHoffmann-La Roche, Inc., NJ, USA, Douglas FastBioanalytical Sciences, Covance Laboratories, WI, USA, Fabio GarofoloBioanalytical Services – Algorithme Pharma Inc., Quebec, Canada, Steve LowesAdvion BioServices, NY, USA, Philip TimmermanJanssen Research & Development, a division of Janssen Pharmaceutica, Belgium & Eric WoolfDMPK-Regulated Bioanalysis, Merck Research Labs, PA, USA Published Online:20 Oct 2010https://doi.org/10.4155/bio.10.146AboutSectionsPDF/EPUB ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareShare onFacebookTwitterLinkedInReddit Keywords: bioanalysisGBCglobalGlobal Bioanalysis Consortiumguidelinesharmonizationhealth authoritiespharmaFigure 1. Conceptual organization of the Global Bioanalysis Consortium.Although harmonization of bioanalytical method validation (BMV) and application has been discussed at scientific forums on several occasions, it was not until the European Bioanalysis Forum (EBF) conference in December 2009 [1], where the European Medicines Agency's (EMA) intended draft bioanalytical method validation guideline [101] was discussed, that the bioanalytical scientists present expressed their strong wish for international harmonization. CT Viswanathan (US FDA/Center for Drug Evaluation and Research [CDER]) and J Welink (Dutch Medicines Evaluation Board [MEB] for EMA), present at the meeting, acknowledged this need for harmonization and encouraged representatives of several international organisations – American Association of Pharmaceutical Scientists (AAPS), Applied Pharmaceutical Analysis (APA), Calibration Validation Group (CVG) and EBF – to work with their respective memberships and collaborate on global BMV harmonization efforts. Specifically, both agency representatives said they would be open to hearing from the international scientific community proposals for consistent harmonized regulatory language.The first action in this direction was to publish the open letter that they had sent to the US FDA and EMA in February 2010, requesting global harmonization of existing or emerging guidances for BMV and sample analysis and offering to support the processes needed [2]. In addition, representatives of the above named organizations published two editorials in the same journal discussing the history of BMV and expressing their views on a future harmonization process [3,4].Concurrent with these publications, the CVG had its fourth workshop on regulated bioanalysis in Montreal. This meeting focussed serious attention on the topic of harmonization of bioanalytical guidelines through a number of speakers from industry and regulatory agencies presenting their ideas and discussing possible future processes with the audience [5]. At the CVG workshop, a unanimous consensus was reached among the five regulatory agencies, the panellists and the international audience that global guidance should be science driven, not prescriptive, and should include rationale behind each requirement to prevent 'box checking' by auditors and reviewers of filings. Furthermore, the need to rise above local issues and focus on globally acceptable language will be pivotal to a successful outcome.To transfer words into actions, it was decided to set-up an all-inclusive Global Bioanalysis Consortium (GBC) consisting of scientific associations with worldwide recognition and influence in order to create one unified document that, after thorough discussion in global conferences, can be presented to the decision makers in each country or region. The intention and expectation is that the document must be influential enough that all agencies will want to adopt it and harmonize their auditing and reviewing approaches.Following the April 2010 CVG meeting in Montreal, the authors came together in a number of teleconferences to lay the foundations of the GBC and take the first steps in building it. This group of founding members set the following goals and objectives for the GBC: ▪ Bring together stakeholders from the pharmaceutical industry, contract research organizations and academia to share current understanding of bioanalysis guidelines, identify differences in these guidelines, or differences in the interpretation or application thereof, to routine bioanalysis;▪ Come forward with recommendations to health authorities and regulatory bodies worldwide on globally agreed best practices for BMV and application of such methods/technologies to the analysis of drugs of all molecular sizes in support of clinical and nonclinical studies;▪ Invite relevant stakeholders, from industry, academia, health authorities and regulatory bodies, to jointly discuss the GBC recommendations at a global conference in order to achieve globally agreed guidelines on bioanalysis;▪ Going forward, to serve as a pivot point on the continued harmonized interpretation and/or updates of globally agreed guidelines.Next, we designed a structure for the Consortium that could be effective: small dedicated teams that give opportunity for scientists from all over the world to participate. In essence, the plan is to set up a steering committee (SC) to guide the process of harmonization, and a number of harmonization teams (HT), to discuss different validation or sample analysis topics. The SC will consist of one or two representatives of every major region and their task will be to: ▪ Coordinate the GBC process of supporting a global BMV harmonizing strategy;▪ Assign harmonization team leaders (see following dicussion);▪ Connect with and support the harmonization teams working on specific topics;▪ Be responsible for communication of the GBC progress to the global community;▪ Represent the GBC at international meetings;▪ Interact with health authorities/regulatory agencies and organize harmonization international meetings/conferences.It is important to note that the SC will not own content of harmonization discussion, but can act as a sounding board. Also, the size of this committee will be kept minimal, but all major regions should be represented. Currently four regions are identified: Europe, North America, Latin America and Asia-Pacific.Connected to the GBC SC will be a group of harmonization team leaders who will be working with their teams on specific topics. They will build and lead the harmonization teams which will work on a number of specific method validation or sample analysis topics. The harmonization team leaders will be responsible for: ▪ Assigning the HT members from the experts volunteering or experts that have been identified in SC–HT leaders meetings;▪ Organizing the HT meetings and documenting the discussions;▪ Connecting with SC to report back on progress and/or get input from;▪ Connecting with other HT leads in case of topic overlapping discussions.The real work on the content will be achieved by the harmonization teams. These consist of the above mentioned HT lead and subject matter experts from multiple regions. In those teams, typically a group of five to ten experts, all aspects relevant for a specific bioanalytical topic will need to be thoroughly discussed and prepared for a broader presentation in a global harmonization meeting bringing together industry, academia and interested health authorities. The teams will need to be aware of what historic discussions have occurred over the past 20 years, what was achieved so far and why we came to those decisions. An overview of the GBC team dynamics is given in Figure 1.There are multiple ways to divide the house of bioanalysis in smaller rooms in which only one specific topic will fit while at the same time, it is almost impossible to avoid any overlap from topic to topic. Especially integrating 'macromolecules/ligand-binding assay' with 'small molecules/LC–MS' is going to be a serious challenge. For example, a possible setup in harmonization teams could be as follows: ▪ General▪ Run acceptance criteria▪ Sample stability▪ ISR▪ Aspects of method transfer▪ Bioanalytical reports▪ Reference standards, quality controls and reagents▪ Quality regime/tiered approach▪ Small molecules/LC–MS specific▪ Calibration, accuracy and precision▪ Sensitivity, specificity and matrix effects▪ Metabolite quantification▪ Macromolecules/LBA specific▪ Calibration, accuracy and precision▪ Sensitivity, specificity and matrix effects▪ ImmunogenicityThe founding members will continue to build the GBC in the coming months and will present their plans at bioanalytical meetings. It is our intention to give full attention to global harmonization and the GBC organisation at the end of the year. More specifically for North America, at the annual AAPS meeting in New Orleans in November [102]; for Europe, at the EBF open meeting in Barcelona in December [103]; and for Asia-Pacific, at the CVG meeting in Shanghai in January 2011 [104]. In those meetings, representatives from the already assigned GBC SC or one of the founding members will speak and seek input from the broader audience. It is our target to have identified and assigned bioanalytical experts to the SC as HT leads and team members in February 2011. Furthermore, we aim to have a GBC website live in the fourth quarter of 2010.We expect, and have already recognized, that many bioanalytical scientists are eager to join the initiative and we would like to welcome you all. However, we are intent on building the Consortium as a group truly representing all regions while at the same time we will need to limit the team sizes to achieve results and avoid big groups that will be hampered by size. We fully recognize that this approach may not present all views, but look to the regional organizations to establish and maintain meetings in which broad participation in topical discussions can occur. Until a formal call for participation is issued, if you would like to express your interest in actively participating, feel invited to contact any of the authors of this article at one of the future meetings.DisclaimerThe views expressed in this article are those of the Global Bionanalysis Consortium and do not necessarily reflect the respective company's position on the subject.Financial & competing interests disclosureThe authors have no relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript. This includes employment, consultancies, honoraria, stock ownership or options, expert testimony, grants or patents received or pending, or royalties. No writing assistance was utilized in the production of this manuscript.Bibliography1 Abbott R. European Bioanalysis Forum, 2nd Open Symposium: The broadening scope of validation: towards best practices in the world of bioanalysis. Bioanalysis2(4),703–708 (2010).Link, CAS, Google Scholar2 Timmerman P, Lowes S, Fast DM, Garofolo F. Request for global harmonization of the guidance for bioanalytical method validation and sample analysis. Bioanalysis2(4),683 (2010).Link, CAS, Google Scholar3 Bansal S, Arnold M, Garofolo F. International harmonization of bioanalytical guidance. Bioanalysis2(4),685–687 (2010).Link, CAS, Google Scholar4 van Amsterdam P, Lausecker B, Luedtke S, Timmerman P, Brudny-Kloeppel M. Towards harmonized regulations for bioanalysis: moving forward! Bioanalysis2(4),689–691 (2010).Link, CAS, Google Scholar5 Savoie N, Garofolo F, van Amsterdam P et al. 2010 White Paper on recent issues in regulated bioanalysis and global harmonization of the bioanalytical guideline – from The 4th Calibrationand Validation Group Workshop. Bioanalysis DOI:10.4155/BIO.10.164 (2010) (In Press).Google Scholar101 EMA Draft Guideline on validation of bioanalytical methods. www.ema.europa.eu/pdfs/human/ewp/19221709en.pdfGoogle Scholar102 FIP Pharmaceutical Sciences 2010 World Congress/AAPS Annual Meeting and Exposition. www.pswc2010.org/Google Scholar103 EBF 3rd Open Conference: From Challenges to Solutions. www.europeanbioanalysisforum.eu/conferences.phpGoogle Scholar104 The 1st Workshop in Asia Pacific on Recent Issues in Regulated Bioanalysis. www.canadianlcmsgroup.com/bioanalysis_asia_workshop.phpGoogle ScholarFiguresReferencesRelatedDetailsCited ByVerification of quantitative analytical methods in medical laboratoriesJournal of Medical Biochemistry, Vol. 40, No. 3Validation of bioanalytical chromatographic methods for the quantification of drugs in biological fluidsBioanalytical method validation: new FDA guidance vs. EMA guideline. Better or worse?Journal of Pharmaceutical and Biomedical Analysis, Vol. 165Transfer from research/academia to clinical/regulatedFerdousi Chowdhury & Anthony Williams15 September 2016 | Bioanalysis, Vol. 8, No. 20Novel calibration approaches for LC-MS bioanalysis28 October 2015Current industrial practices and regulatory requirements to assess analyte and reagent stability using ligand-binding assaysJin Wang, William Nowatzke & Mark Ma25 June 2015 | Bioanalysis, Vol. 7, No. 11Large-scale retrospective evaluation of regulated liquid chromatography–mass spectrometry bioanalysis projects using different total error approachesJournal of Chromatography B, Vol. 983-984Introduction to the Proposals from the Global Bioanalysis Consortium Harmonization Team2 October 2014 | The AAPS Journal, Vol. 16, No. 6Repeat Analysis and Incurred Sample Reanalysis: Recommendation for Best Practices and Harmonization from the Global Bioanalysis Consortium Harmonization Team19 August 2014 | The AAPS Journal, Vol. 16, No. 6Method Transfer, Partial Validation, and Cross Validation: Recommendations for Best Practices and Harmonization from the Global Bioanalysis Consortium Harmonization Team5 September 2014 | The AAPS Journal, Vol. 16, No. 6Some unnecessary or inadequate common practices in regulated LC–MS bioanalysisAimin Tan, Kayode Awaiye & Fethi Trabelsi21 November 2014 | Bioanalysis, Vol. 6, No. 20Bioanalytical chromatographic method validation according to current regulations, with a special focus on the non-well defined parameters limit of quantification, robustness and matrix effectJournal of Chromatography A, Vol. 1353Conference Report: Moving forward together: "we are making progress"William D van Dongen & Luuk C Renfurm20 June 2014 | Bioanalysis, Vol. 6, No. 9Outsourcing strategy: local versus international contract research organizationsDieter Zimmer24 June 2014 | Bioanalysis, Vol. 6, No. 10Impact of calibrator concentrations and their distribution on accuracy of quadratic regression for liquid chromatography–mass spectrometry bioanalysisAnalytica Chimica Acta, Vol. 815ISR: background, evolution and implementation, with specific consideration for ligand-binding assaysJohn WA Findlay & Marian M Kelley29 January 2014 | Bioanalysis, Vol. 6, No. 3Bioanalytical method validation and bioanalysis in regulated settingsComparison of two-concentration with multi-concentration linear regressions: Retrospective data analysis of multiple regulated LC–MS bioanalytical projectsJournal of Chromatography B, Vol. 934International Regulations and Quality Standards of Bioanalysis30 August 2013Application of HPLC-ELSD for the Quantification of 5-Aminolevulinic Acid after Penetration into Human Skin Ex VivoAnalytical Letters, Vol. 46, No. 5The European Bioanalysis Forum community's evaluation, interpretation and implementation of the European Medicines Agency guideline on Bioanalytical Method ValidationPeter van Amsterdam, Arjen Companjen, Margarete Brudny-Kloeppel, Michaela Golob, Silke Luedtke & Philip Timmerman13 March 2013 | Bioanalysis, Vol. 5, No. 6Novel BiopharmaceuticalsComparison of different linear calibration approaches for LC–MS bioanalysisJournal of Chromatography B, Vol. 9112012 White Paper on Recent Issues in Bioanalysis and Alignment of Multiple GuidelinesBinodh DeSilva, Fabio Garofolo, Mario Rocci, Suzanne Martinez, Isabelle Dumont, France Landry, Catherine Dicaire, Gabriella Szekely-Klepser, Russell Weiner, Mark Arnold, Surendra Bansal, Kevin Bateman, Ronald Bauer, Brian Booth, Scott Davis, Sherri Dudal, Dominique Gouty, John Grundy, Sam Haidar, Roger Hayes, Mohammed Jemal, Surinder Kaur, Marian Kelley, Magnus Knutsson, Olivier Le Blaye, Jean Lee, Steve Lowes, Mark Ma, Toshinari Mitsuoka, João Tavares Neto, Robert Nicholson, Eric Ormsby, Jeffrey Sailstad, Lauren Stevenson, Daniel Tang, Jan Welink, CT Viswanathan, Laixin Wang, Eric Woolf & Eric Yang9 October 2012 | Bioanalysis, Vol. 4, No. 18Regulated drug bioanalysis for human pharmacokinetic studies and therapeutic drug managementYong Huang, Robert Shi, Winnie Gee & Richard Bonderud3 September 2012 | Bioanalysis, Vol. 4, No. 15Validation and verification of measurement methods in clinical chemistryElvar Theodorsson6 February 2012 | Bioanalysis, Vol. 4, No. 3Conference Report: US FDA/EMA harmonization of their bioanalytical guidance/guideline and activities of the Global Bioanalytical ConsortiumFabio Garofolo, Josée Michon, Virginie Leclaire, Brian Booth, Stephen Lowes, CT Viswanathan, Jan Welink, Sam Haidar, Leonardo de Souza Teixeira, Daniel Tang & Binodh Desilva6 February 2012 | Bioanalysis, Vol. 4, No. 3Conference Report: Discussion on harmonization and globalization of bioanalytical guidances at the 19th International Reid Bioanalytical ForumFabio Garofolo, John Smeraglia, Ray Briggs, Mark Seymour & Howard Hill20 December 2011 | Bioanalysis, Vol. 3, No. 24Aspects of bioanalytical method validation for the quantitative determination of trace elementsKeith E Levine, Christopher Tudan, Peter M Grohse, Frank X Weber, Michael A Levine & Yu-Seon J Kim9 August 2011 | Bioanalysis, Vol. 3, No. 15Conducting remote bioanalytical data monitoring and review based on scientific quality objectivesLing He5 July 2011 | Bioanalysis, Vol. 3, No. 13Bioanalysis in Latin America: where are we and where are we going?Rafael Eliseo Barrientos-Astigarraga18 May 2011 | Bioanalysis, Vol. 3, No. 10Historical perspective on the development and evolution of bioanalytical guidance and technologyVinod P Shah & Surendra Bansal21 April 2011 | Bioanalysis, Vol. 3, No. 8Conference Report: The 1st Conference in Asia-Pacific on Recent Issues in BioanalysisIsabelle Dumont & Fabio Garofolo31 March 2011 | Bioanalysis, Vol. 3, No. 7Unique challenges of providing bioanalytical support for biological therapeutic pharmacokinetic programsWilliam L Nowatzke, Kathryn Rogers, Edward Wells, Ronald R Bowsher, Chad Ray & Steve Unger9 March 2011 | Bioanalysis, Vol. 3, No. 5Quality assessment of bioanalytical quantification of monoclonal antibody drugsJean W Lee & Marian Kelley9 March 2011 | Therapeutic Delivery, Vol. 2, No. 3Implications of differences in bioanalytical regulations between Canada, USA and South AmericaMark E Arnold15 February 2011 | Bioanalysis, Vol. 3, No. 3Conference Report: Bioanalytical Procedures and Regulation: Towards Global HarmonizationHoward M Hill21 February 2011 | Bioanalysis, Vol. 3, No. 4Formation of a Global Contract Research Organization Council for BioanalysisNoel Premkumar, Stephen Lowes, James Jersey, Fabio Garofolo, Isabelle Dumont, Robert Masse, Betty Stamatiou, Maria C Caturla, Ray Steffen, Michele Malone, Elliot Offman, Timothy Samuels, Phillip Oldfield, Lorella Di Donato, Douglas Fast, Daniel Tang, Marc Moussallie, John Doughty, Mario Rocci, Mike Buonarati, Dominique Gouty, Darioush Dadgar, John Stamatopoulos, Alan Breau, Bernard Ntsikoussalabongui, Mohammed Bouhajib, Bob Nicholson, Richard Tacey, Peter Ketelaar, Chad Briscoe, Shane Karnik, Jaap Wieling, Jon Kirk Smith, Michael J Reid, Richard LeLacheur, John Chapdelaine, Saadya Fatmi, Farhad Sayyarpour, Xinping Fang, Jeremy Cook & David Browne20 October 2010 | Bioanalysis, Vol. 2, No. 11 Vol. 2, No. 11 Follow us on social media for the latest updates Metrics History Published online 20 October 2010 Published in print November 2010 Information© Future Science LtdKeywordsbioanalysisGBCglobalGlobal Bioanalysis Consortiumguidelinesharmonizationhealth authoritiespharmaDisclaimerThe views expressed in this article are those of the Global Bionanalysis Consortium and do not necessarily reflect the respective company's position on the subject.Financial & competing interests disclosureThe authors have no relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript. This includes employment, consultancies, honoraria, stock ownership or options, expert testimony, grants or patents received or pending, or royalties. No writing assistance was utilized in the production of this manuscript.PDF download