Human Anti-antibody Response
- 1.9k Downloads
Antibodies are emerging as a new drug class with many of these approved and marketed. Antibodies may be non-human, chimeric, humanized or fully human. All these have the potential to elicit an immune response in the host which may impact on safety and efficacy. Therefore, assessment of immunogenicity of the therapeutic protein is an essential part of its clinical development. This involves testing strategies which provide relevant information on antibody responses. This chapter describes a simple ELISA method to detect human anti-antibody response.
KeywordsTherapeutic Protein Phosphate Citrate Buffer Assay Validation Negative Control Sample Direct ELISA
- Avramis VI, Avramis EV, Hunter W, Long MC (2009) Immunogenicity of native or pegylated E. coli and Erwinia asparaginases assessed by ELISA and surface plasmon resonance (SPR-biacore) assays of IgG antibodies (Ab) in sera from patients with acute lymphoblastic leukemia (ALL). Anticancer Res 29:299–302PubMedGoogle Scholar
- Koren E, Smith HW, Shores E, Shankar G, Finco-Kent D, Rup B, Barrett YC, Devanarayan V, Gorovits B, Gupta S, Parish T, Quarmby V, Moxness M, Swanson SJ, Taniguchi G, Zuckerman LA, Stebbins CC, Mire-Sluis A (2008) Recommendations on risk-based strategies for detection and characterization of antibodies against biotechnology products. J Immunol Methods 333:1–9PubMedCrossRefGoogle Scholar
- Mire-Sluis AR, Barrett YC, Devanarayan V, Koren E, Liu H, Maia M, Parish T, Scott G, Shankar G, Shores E, Swanson SJ, Taniguchi G, Wierda D, Zuckerman LA (2004) Recommendations for the design and optimization of immunoassays used in the detection of host antibodies against biotechnology products. J Immunol Methods 289:1–16PubMedCrossRefGoogle Scholar
- Shankar G, Devanarayan V, Amaravadi L, Barrett YC, Bowsher R, Finco-Kent D, Fiscella M, Gorovits B, Kirschner S, Moxness M, Parish T, Quarmby V, Smith H, Smith W, Zuckerman LA, Koren E (2008) Recommendations for the validation of immunoassays used for detection of host antibodies against biotechnology products. J Pharm Biomed Anal 48:1267–1281PubMedCrossRefGoogle Scholar