Module 9 2021

22/03/2021

Guidance US Food and Drug Administration (FDA)

Guidance for Industry - Immunogenicity Assessment for Therapeutic Protein Products. Food and Drug Administration, US. August 2014. www.fda.gov/downloads/drugs/guidances/ucm338856.pdf

Guidance for Industry – Immunogenicity Testing of Therapeutic Protein Products – Developing and Validating Assays for Anti-Drug Antibody Detection. Food and Drug Administration, US. January 2019. https://www.fda.gov/Drugs/DevelopmentApprovalProcess/Manufacturing/ucm603333.ht m

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Recommendations, AAPS White papers & others

Recommendations for the design & optimization of immunoassays used in the detection of host antibodies against biotechnology products (2004). Mire-Sluis et al., J.Immunol. Methods, 289 : 1-16

Recommendations for the design, optimization, and qualification of cell-based assays used for the detection of neutralizing antibody responses elicited to biological therapeutics (2007). Gupta et al., J. Immunol. Methods, 321: 1-18

Assessment and reporting of the clinical immunogenicity of therapeutic proteins and peptides- harmonized terminology and tactical recommendations (2014). Shankar et al., AAPS J., 16(4): 658-73

Recommendations for the characterization of immunogenicity response to multiple domain biotherapeutics (2014). Gorovits B et al., J. Immunol. Methods., 408:1-12

Strategies to Determine Assay Format for the Assessment of Neutralizing Antibody Responses to Biotherapeutics (2016). Wu B et al., AAPS J., 18(6):1335-1350

Recommendations for the Development and Validation of Neutralizing Antibody Assays in Support of Biosimilar Assessment (2017). Gouty D et al., AAPS J., 20(1):25

Recommendations for the Assessment and Management of Pre-existing Drug-Reactive Antibodies During Biotherapeutic Development (2017). Xue L et al., AAPS J., 19(6):1576-1586.

Recommendations for Systematic Statistical Computation of Immunogenicity Cut Points (2017). Devanarayan V et al., AAPS J., 19(5):1487-1498

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