13,683
Views
0
CrossRef citations to date
0
Altmetric
White Paper

2017 White Paper on Recent Issues in Bioanalysis: A Global Perspective on Immunogenicity Guidelines & Biomarker Assay Performance (Part 3 – Lba: Immunogenicity, Biomarkers and PK Assays)

, , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , & show all
Pages 1967-1996 | Received 21 Sep 2017, Accepted 29 Sep 2017, Published online: 05 Dec 2017

References

  • Savoie N , BoothBP, BradleyTet al. 2008 White Paper: the 2nd Calibration and Validation Group Workshop on recent issues in good laboratory practice bioanalysis. Bioanalysis1 (1), 19–30 (2009).
  • Savoie N , GarofoloF, van AmsterdamPet al. 2009 White Paper on recent issues in regulated bioanalysis from the 3rd Calibration and Validation Group Workshop. Bioanalysis2 (1), 53–68 (2010).
  • Savoie N , GarofoloF, van AmsterdamPet al. 2010 White Paper on recent issues in regulated bioanalysis and global harmonization of bioanalytical guidance. Bioanalysis2 (12), 1945–1960 (2010).
  • Garofolo F , RocciM, DumontIet al. 2011 White Paper on recent issues in bioanalysis and regulatory findings from audits and inspections. Bioanalysis3 (18), 2081–2096 (2011).
  • DeSilva B , GarofoloF, RocciMet al. 2012 White Paper on recent issues in bioanalysis and alignment of multiple guidelines. Bioanalysis4 (18), 2213–2226 (2012).
  • Stevenson L , RocciM, GarofoloFet al. 2013 White Paper on recent issues in bioanalysis: “Hybrid” - the best of LBA & LC/MS. Bioanalysis5 (23), 2903–2918 (2013).
  • Fluhler E , HayesR, GarofoloFet al. 2014 White Paper on recent issues in bioanalysis: a full immersion in bioanalysis (Part 1 – small molecules by LCMS). Bioanalysis6 (22), 3039–3049 (2014).
  • Dufield D , NeubertH, GarofoloFet al. 2014 White Paper on recent issues in bioanalysis: a full immersion in bioanalysis (Part 2 – hybrid LBA/LCMS, ELN & regulatory agencies’ input). Bioanalysis6 (23), 3237–3249 (2014).
  • Stevenson L , AmaravadiL, MylerHet al. 2014 White Paper on recent issues in bioanalysis: a full immersion in bioanalysis (Part 3 – LBA and immunogenicity). Bioanalysis6 (24), 3355–3368 (2014).
  • Welink J , FluhlerE, HughesNet al. 2015 White Paper on recent issues in bioanalysis: focus on new technologies and biomarkers (Part 1 – small molecules by LCMS). Bioanalysis7 (22), 2913–2925 (2015).
  • Ackermann B , NeubertH, HughesNet al. 2015 White Paper on recent issues in bioanalysis: focus on new technologies and biomarkers (Part 2 – hybrid LBA/LCMS and input from regulatory agencies). Bioanalysis7 (23), 3019–3034 (2015).
  • Amaravadi L , SongA, MylerHet al. 2015 White Paper on recent issues in bioanalysis: focus on new technologies and biomarkers (Part 3 – LBA, biomarkers and immunogenicity). Bioanalysis7 (24), 3107–3124 (2015).
  • Yang E , WelinkJ, CapeSet al. 2016 White Paper on recent issues in bioanalysis: focus on biomarker assay validation (BAV) (Part 1 – small molecules, peptides and small molecule biomarkers by LCMS). Bioanalysis8 (22), 2363–2378 (2016).
  • Song A , LeeA, GarofoloFet al. 2016 White Paper on recent issues in bioanalysis: focus on biomarker assay validation (BAV): (Part 2 – Hybrid LBA/LCMS and input from regulatory agencies). Bioanalysis8 (23), 2457–2474 (2016).
  • Richards S , AmaravadiL, PillutlaRet al. 2016 White Paper on recent issues in bioanalysis: focus on biomarker assay validation (BAV): (Part 3 – LBA, biomarkers and immunogenicity). Bioanalysis8 (23), 2475–2496 (2016).
  • Staack RF , JordanG, HeinrichJ. Mathematical simulations for bioanalytical assay development: the (un-)necessity and (im-)possibility of free drug quantification. Bioanalysis4 (4), 381–395 (2012).
  • Schick E , StaackRF, HaakMet al. Validation of a ligand-binding assay for active protein drug quantification following the ‘free analyte QC concept’. Bioanalysis8 (24), 2537–2549 (2016).
  • Lowes S , AckermannBL. Conference report - AAPS and US FDA Crystal City VI workshop on bioanalytical method validation for biomarkers. Bioanalysis8 (3), 163–167 (2016).
  • Arnold ME , BoothB, KingL, RayC. Workshop report: Crystal City VI-bioanalytical method validation for biomarkers. AAPS J. 18 (6), 1366–1372 (2016).
  • US Department of Health and Human Services, US FDA, Center for Drug Evaluation and Research, Center for Veterinary Medicine . Draft guidance for industry, bioanalytical method validation. Rockville, MD, USA (2013). http://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm368107.pdf.
  • Pharmaceutical Research and Manufacturers of America . 2016 Biopharmaceutical research industry profile. PhRMA, Washington DC, USA (April 2016).
  • DiMasi JA , GrabowskiHG, HansenRW. Innovation in the pharmaceutical industry: new estimates of R&D costs. J. Health Econ. 47, 20–33 (2016).
  • European Medicines Agency. Committee for Medicinal Products for Human Use (CHMP) . Guideline on immunogenicity assessment of biotechnology-derived therapeutic proteins. London, UK (2007). EMEA/CHMP/BMWP/14327/2006. http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500003946.pdf.
  • European Medicines Agency. Committee for Medicinal Products for Human Use (CHMP) . Draft guideline on Immunogenicity assessment of biotechnology-derived therapeutic proteins. London, UK (2015). EMEA/CHMP/BMWP/14327/2006 Rev. 1. http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2015/10/WC500194507.pdf.
  • US Department of Health and Human Services, US FDA, Center for Drug Evaluation and Research, Center for Biologics Evaluation and Research, Center for Devices and Radiological Health (CDRH) . Draft guidance for industry, assay development and validation for immunogenicity testing of therapeutic protein products. Rockville, MD, USA (2016). http://www.fda.gov/downloads/Drugs/…/Guidances/UCM192750.pdf.
  • European Medicines Agency. Committee for Medicinal Products for Human Use (CHMP) . Guideline on Immunogenicity Assessment of Therapeutic Proteins. London, UK, EMEA/CHMP/BMWP/14327/2006 Rev. 1 (2017). http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2017/06/WC500228861.pdf.
  • European Medicines Agency. Committee for Medicinal Products for Human Use (CHMP) . Guideline on immunogenicity assessment of monoclonal antibodies intended for in vivo clinical use. London, UK (2012). http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2012/06/WC500128688.pdf.
  • Koren E , SmithHW, ShoresEet al. Recommendations on risk-based strategies for detection and characterization of antibodies against biotechnology products. J. Immuno. Met. 333, 1–9 (2008).
  • Wu B , ChungS, JiangXRet al. Strategies to determine assay format for the assessment of neutralizing antibody responses to biotherapeutics. AAPS J. doi: 10.1208/s12248-016-9954-6 (2016) ( Epub ahead of print).
  • Shankar G , ArkinS, CoceaLet al. Assessment and reporting of the clinical immunogenicity of therapeutic proteins and peptides—harmonized terminology and tactical recommendations. AAPS J. 16 (4), 658–673 (2014).
  • Plotkin SA . Correlates of protection induced by vaccination. Clin. Vaccine Immunol. 17 (7), 1055–65 (2010).
  • Zhou L , HoofringSA, WuYet al. Stratification of antibody-positive subjects by antibody level reveals an impact of immunogenicity on pharmacokinetics. AAPS J. 15 (1), 30–40 (2013).
  • Zoghbi J , XuY, GrabertRet al. A breakthrough novel method to resolve the drug and target interference problem in immunogenicity assays. J. Immuno. Meth. 426, 62–69 (2015).
  • Wessels U , SchickE, RitterMet al. Novel drug and soluble target tolerant antidrug antibody assay for therapeutic antibodies bearing the P329G mutation. Bioanalysis9 (11), 849–859 (2017).
  • Stubenrauch K , WesselsU, EssigUet al. Evaluation of a generic immunoassay with drug tolerance to detect immune complexes in serum samples from cynomolgus monkeys after administration of human antibodies. J. Pharm. Biomed. Anal. 52 (2), 249–254 (2010).
  • Dai S , SchantzA, Clements-EganAet al. Development of a method that eliminates false-positive results due to nerve growth factor interference in the assessment of fulranumab immunogenicity. AAPS J. 16, 464–477 (2014).
  • Gorovits B , WakshullE, PillutlaRet al. Recommendations for the characterization of immunogenicity response to multiple domain biotherapeutics. J. Immunol. Methods408, 1–12 (2014).
  • Myler H , HruskaMW, SrinivasanSet al. Anti-PEG antibody bioanalysis: a clinical case study with PEG-IFN-λ-1a and PEG-IFN-α2a in naive patients. Bioanalysis7 (9), 1093–1106 (2015).
  • European Medicines Agency. Committee for Medicinal Products for Human Use (CHMP) . Guideline on bioanalytical method validation. EMEA/CHMP/EWP/192217/2009. London, UK (2011). www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2011/08/WC500109686.pdf.
  • Bendtzen K , GeborekP, SvensonMet al. Individualized monitoring of drug bioavailability and immunogenicity in rheumatoid arthritis patients treated with the tumor necrosis factor alpha inhibitor infliximab. Arthritis Rheum. 54 (12), 3782–3789 (2006).
  • Jensen PEH , SellebjergF, SondergaardHBet al. Correlation between anti-interferon-b binding and neutralizing antibodies in interferon-b-treated multiple sclerosis patients. Eur. J. Neurol. 19, 1311–1317 (2012).
  • Verch T , RoselleC, Shank-RetzlaffM. Reduction of dilution error in ELISAs using an internal standard. Bioanalysis8 (14), 1451–1464 (2016).
  • Mingozzi F , MausMV, HuiDJet al. CD8+ T-cell responses to adeno associated virus capsid in humans. Nat. Med. 13 (4), 419–422 (2007).
  • Mendell JR , CampbellK, Rodino-KlapacLet al. Dystrophin immunity in Duchenne’s muscular dystrophy. N. Engl J. Med. 363 (15), 1429–1437 (2010).
  • Mingozzi F , HighKA. Immune responses to AAV vectors: overcoming barriers to successful gene therapy. Blood122 (1), 23–36 (2013).
  • US Department of Health and Human Services, US FDA, Center for Drug Evaluation and Research . Guidance for industry, nonclinical safety evaluation of drug or biologic combinations. Rockville, MD, USA (2006). https://www.fda.gov/OHRMS/DOCKETS/98fr/05d-0004-gdl0002.pdf.
  • US Department of Health and Human Services, US FDA, Center for Drug Evaluation and Research . Guidance for industry, codevelopment of two or more new investigational drugs for use in combination. Rockville, MD, USA (2013). https://www.fda.gov/downloads/drugs/guidances/ucm236669.pdf.
  • Mobley A , LinderSK, BraeuerRet al. A survey on data reproducibility in cancer research provides insights into our limited ability to translate findings from the laboratory to the clinic. PLoS ONE8 (5), e63221 (2013).
  • Dakappagari N , ZhangH, StephenLet al. Recommendations for clinical biomarker specimen preservation and stability assessments. Bioanalysis9 (8), 643–653 (2017).
  • Ellervik C , VaughtJ. Preanalytical variables affecting the integrity of human biospecimans in biobanking. Clin. Chem. 61 (7), 914–934 (2015).
  • Lee JW , DevanarayanV, BarrettYCet al. Fit-for-purpose method development and validation for successful biomarker measurement. Pharm. Res. 23 (2), 312–328 (2006).
  • Cummings J , WardTH, DiveC. Fit-for-purpose biomarker method validation in anticancer drug development. Drug Discovery Today15 (19–20), 816–825 (2010).
  • Cowan K , GaoX, ParabVet al. Fit-for-purpose biomarker immunoassay qualification and validation: three case studies. Bioanalysis8 (22), 2329–2340 (2016).
  • Hougton R , GoutyD, AllinsonJet al. Recommendations on biomarker bioanalytical method validation by GCC. Bioanalysis4 (20), 2439–2446 (2012).
  • FDA-NIH Biomarker Working Group . BEST (Biomarkers, EndpointS, and other Tools) Resource. US Food and Drug Administration, Silver Spring, MD, USA ; US National Institutes of Health, Bethesda, MD, USA (2016).
  • Piccoli SP , SauerJM, AmurSet al. Points to consider document: scientific and regulatory considerations for the analytical validation of assays used in the qualification of biomarkers in biological matrices. Biomarker Assay Collaborative Evidentiary Considerations Writing Group. https://healthpolicy.duke.edu/sites/default/files/atoms/files/white_paper_6_14_17_0.pdf.
  • Ricós C , AlvarezV, CavaF. Current databases on biological variation: pros, cons and progress. Scand. J. Clin. Lab. Invest. 59 (7), 491–500 (1999).

Reprints and Corporate Permissions

Please note: Selecting permissions does not provide access to the full text of the article, please see our help page How do I view content?

To request a reprint or corporate permissions for this article, please click on the relevant link below:

Academic Permissions

Please note: Selecting permissions does not provide access to the full text of the article, please see our help page How do I view content?

Obtain permissions instantly via Rightslink by clicking on the button below:

If you are unable to obtain permissions via Rightslink, please complete and submit this Permissions form. For more information, please visit our Permissions help page.