Portal de Periódicos da CAPES

Understanding and mitigating impact of immunogenicity on pharmacokinetic assays

2011; Future Science Ltd; Volume: 3; Issue: 16 Linguagem: Inglês

10.4155/bio.11.162

1757-6199

Joleen T. White, Michaela Golob, Jeffrey Sailstad,

Protein purification and stability

BioanalysisVol. 3, No. 16 EditorialUnderstanding and mitigating impact of immunogenicity on pharmacokinetic assaysJoleen T White, Michaela Golob & Jeffrey SailstadJoleen T WhiteBiogen Idec, 14 Cambridge Center, Cambridge, MA 02142, Michaela GolobMerck Serono, MS-RD DMPK/rADME, Haidling 17, D-85567 Grafing, Germany & Jeffrey Sailstad† Author for correspondenceSailstad & Associates Inc., 6 Porchlight Court, Durham, NC 27707, USA. Published Online:30 Aug 2011https://doi.org/10.4155/bio.11.162AboutSectionsView ArticleView Full TextPDF/EPUB ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareShare onFacebookTwitterLinkedInRedditEmail View articleKeywords: anti-drug antibodiesimmunogenicityinterferencepharmacokineticpharmacodynamicsBibliography1 Smith HW, Butterfield A, Sun D. Detection of antibodies against therapeutic proteins in the presence of residual therapeutic protein using a solid-phase extraction with acid dissociation (SPEAD) sample treatment prior to ELISA. Regulatory Toxicology and Pharmacology.49(3),230–237 (2007).Crossref, Medline, CAS, Google Scholar2 Koren E, Zuckerman LA, Mire-Sluis AR. Immune responses to therapeutic proteins in humans – clinical significance, assessment and prediction. Curr. Pharm. Biotechnol.3(11),349–360 (2002).Crossref, Medline, CAS, Google Scholar3 US Department of Health and Human Services, Food and Drug Administration (FDA) Center for Drug Evaluation and Research (CDER), Center for Biologics Evaluation and Research (CBER). Guidance for Industry Bioanalytical Method Validation, May 2001.Google Scholar4 DeSilva B, Smith W, Weiner R et al. Recommendations for the bioanalytical method validation of ligand-binding assays to support pharmacokinetic assessments of macromolecules. Pharm. Res.20(11),1885–1900 (2003).Crossref, Medline, CAS, Google Scholar101 Therapeutic Immunogenicity Focus Group of the American Association of Pharmaceutical Scientists. www.aaps.org/inside/focus_groups/TherPro/index.asp (Accessed June 2011).Google Scholar102 Global Bioanalysis Consortium. www.globalbioanalysisconsortium.org (Accessed June 2011).Google ScholarFiguresReferencesRelatedDetailsCited By2021 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)Surinder Kaur, Stephen C Alley, Matt Szapacs, Amanda Wilson, Eugene Ciccimaro, Dian Su, Neil Henderson, Linzhi Chen, Fabio Garofolo, Shawna Hengel, Wenying Jian, John F Kellie, Anita Lee, John Mehl, Joe Palandra, Haibo Qiu, Natasha Savoie, Diaa Shakleya, Ludovicus Staelens, Hiroshi Sugimoto, Giane Sumner, Jan Welink, Robert Wheller, Y-J Xue, Jianing Zeng, Jinhui Zhang, Huiyu Zhou, Jian Wang, Scott Summerfield, Olga Kavetska, Lieve Dillen, Ragu Ramanathan, Mike Baratta, Arindam Dasgupta, Anna Edmison, Luca Ferrari, Sally Fischer, Daniela Fraier, Sam Haidar, Kathrin Heermeier, Christopher James, Allena Ji, Lina Luo, Gustavo Mendes Lima Santos, Noah Post, Anton I Rosenbaum, Sune Sporring, Sekhar Surapaneni, Stephen Vinter, Katty Wan, Eric Woolf, Olga Kavetska, Seongeun (Julia) Cho, Elham Kossary, Sandra Prior, Mohsen Rajabi Abhari, Catherine Soo, Yow-Ming Wang, Abbas Bandukwala, Elana Cherry, Isabelle Cludts, Soma Ghosh, Shirley Hopper, Akiko Ishii-Watabe, Susan Kirshner, Kevin Maher, Kimberly Maxfield, Joao Pedras-Vasconcelos, Yoshiro Saito, Dean Smith, Therese Solstad, Daniela Verthelyi, Meenu Wadhwa, Leslie Wagner, Günter Waxenecker, Haoheng Yan & Lucia Zhang17 May 2022 | Bioanalysis, Vol. 14, No. 9High ionic strength dissociation assay (HISDA) for high drug tolerant immunogenicity testingGregor Jordan, Alexander Pöhler, Florence Guilhot, Meike Zaspel & Roland F Staack30 June 2020 | Bioanalysis, Vol. 12, No. 12Generic Peptide Strategies for LC-MS/MS Bioanalysis of Human Monoclonal Antibody Drugs and Drug Candidates2 June 2017Immunogenicity and its effect on pharmacokinetics of biotherapeutics3 March 2016Generic method approaches for monoclonal antibody therapeutics analysis using both ligand binding and LC–MS/MS techniquesJean W Lee9 December 2015 | Bioanalysis, Vol. 8, No. 1Quantification of a bifunctional drug in the presence of an immune response: a ligand-binding assay specific for 'active' drugRoland F Staack, Gregor Jordan, Maria Viert, Martin Schäfer, Apollon Papadimitriou & Julia Heinrich20 October 2015 | Bioanalysis, Vol. 7, No. 24An exploratory universal LC–MS/MS assay for bioanalysis of hinge region-stabilized human IgG4 mAbs in clinical studiesMichael T Furlong, Craig Titsch, Weifeng Xu, Hao Jiang, Mohammed Jemal & Jianing Zeng26 August 2014 | Bioanalysis, Vol. 6, No. 13LC–MS/MS quantification of next-generation biotherapeutics: a case study for an IgE binding Nanobody in cynomolgus monkey plasmaKoen Sandra, Kjell Mortier, Lucie Jorge, Luis C Perez, Pat Sandra, Sofie Priem, Sofie Poelmans & Marie-Paule Bouche20 June 2014 | Bioanalysis, Vol. 6, No. 9A White Paper—Consensus and Recommendations of a Global Harmonization Team on Assessing the Impact of Immunogenicity on Pharmacokinetic Measurements29 March 2014 | The AAPS Journal, Vol. 16, No. 3Bioanalytical challenges of biosimilarsRafiq Islam29 January 2014 | Bioanalysis, Vol. 6, No. 3Free analyte QC concept: a novel approach to prove correct quantification of free therapeutic protein drug/biomarker concentrationsRoland F Staack, Gregor Jordan, Uwe Dahl & Julia Heinrich25 February 2014 | Bioanalysis, Vol. 6, No. 4Analytical assay platforms for soluble target engagement biomarkers: old favorites and emerging technologiesJoanne Goodman & Balaji Agoram3 December 2013 | Bioanalysis, Vol. 5, No. 23Universal immunogenicity validation and assessment during early biotherapeutic development to support a green laboratoryAmi C Bautista, Lei Zhou & Vibha Jawa18 October 2013 | Bioanalysis, Vol. 5, No. 20Impact of Anti-Drug Antibodies in Preclinical Pharmacokinetic Assessment8 May 2013 | The AAPS Journal, Vol. 15, No. 3Is the tiered immunogenicity testing of biologics the adequate approach in preclinical development?Melody Sauerborn27 March 2013 | Bioanalysis, Vol. 5, No. 7Free and total biotherapeutic evaluation in chromatographic assays: interference from targets and immunogenicityJoleen T White & Leo E Bonilla23 October 2012 | Bioanalysis, Vol. 4, No. 19 Vol. 3, No. 16 Follow us on social media for the latest updates Metrics Downloaded 644 times History Published online 30 August 2011 Published in print August 2011 Information© Future Science LtdKeywordsanti-drug antibodiesimmunogenicityinterferencepharmacokineticpharmacodynamicsAcknowledgementsThe authors would like to thank all the members of the Ligand Binding Assay Bioanalytical Focus Group and European Bioanalysis Forum who completed the preconference survey and the session attendees for a vigorous conversation.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