References
- Guidance for Industry Immunogenicity Assessment for Therapeutic Protein Products (2014). www.fda.gov/downloads/drugs/guidances/ucm338856.pdf
- Guideline on Immunogenicity assessment of therapeutic proteins (EMEA/CHMP/BMWP/14327/2006 Rev 1) (2017). www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2017/06/WC500228861.pdf
- 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).
- Morgan P , Van Der GraafPH, ArrowsmithJet al. Can the flow of medicines be improved? Fundamental pharmacokinetic and pharmacological principles toward improving Phase II survival. Drug Discov. Today17 (9–10), 419–424 (2012).
- Liang M , SchwickartM, SchneiderAKet al. Receptor occupancy assessment by flow cytometry as a pharmacodynamic biomarker in biopharmaceutical development. Cytometry B Clin. Cytom. 90 (2), 117–127 (2016).
- Wagner JA . Strategic approach to fit-for-purpose biomarkers in drug development. Annu. Rev. Pharmacol. Toxicol. 48, 631–651 (2008).
- Xu Z , DavisHM, ZhouH. Clinical impact of concomitant immunomodulators on biologic therapy: pharmacokinetics, immunogenicity, efficacy and safety. J. Clin. Pharmacol. 55 (Suppl. 3), S60–S74 (2015).
- Smith HW , ButterfieldA, SunD. 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. Regul. Toxicol. Pharmacol. 49 (3), 230–237 (2007).
- Mire-Sluis AR , BarrettYC, DevanarayanVet al. Recommendations for the design and optimization of immunoassays used in the detection of host antibodies against biotechnology products. J. Immunol. Methods289 (1–2), 1–16 (2004).
- Lu Y , KhawliLA, PurushothamaS, TheilFP, PartridgeMA. Recent advances in assessing immunogenicity of therapeutic proteins: impact on biotherapeutic development. J. Immunol. Res. 2016, 8141269 (2016).
- Dai S , SchantzA, Clements-EganA, CannonM, ShankarG. Development of a method that eliminates false-positive results due to nerve growth factor interference in the assessment of fulranumab immunogenicity. AAPS J. 16 (3), 464–477 (2014).
- Zoghbi J , XuY, GrabertR, TheobaldV, RichardsS. A breakthrough novel method to resolve the drug and target interference problem in immunogenicity assays. J. Immunol. Methods426, 62–69 (2015).
- Baker M . 1500 scientists lift the lid on reproducibility. Nature533 (7604), 452–454 (2016).