title: Determinants of immunogenic response to protein therapeutics.
abstract: Protein therapeutics occupy a very significant position in the biopharmaceutical market. In addition to the preclinical, clinical and post marketing challenges common to other drugs, unwanted immunogenicity is known to affect efficacy and/or safety of most biotherapeutics. A standard set of immunogenicity risk factors are routinely used to inform monitoring strategies in clinical studies. A number of in-silico, in vivo and in vitro approaches have also been employed to predict immunogenicity of biotherapeutics, but with limited success. Emerging data also indicates the role of immune tolerance mechanisms and impact of several product-related factors on modulating host immune responses. Thus, a comprehensive discussion of the impact of innate and adaptive mechanisms and molecules involved in induction of host immune responses on immunogenicity of protein therapeutics is needed. A detailed understanding of these issues is essential in order to fully exploit the therapeutic potential of this class of drugs. This Roundtable Session was designed to provide a common platform for discussing basic immunobiological and pharmacological issues related to the role of biotherapeutic-associated risk factors, as well as host immune system in immunogenicity against protein therapeutics. The session included overview presentations from three speakers, followed by a panel discussion with audience participation.
authors: BioTherapeutics Pharmaceutical Sciences, Pharmaceutical Research & Development, Pfizer Inc., Chesterfield, MO 63017, USA.
authors: Satish K
authors: SK
authors: Singh
authors: Leslie P
authors: LP
authors: Cousens
authors: David
authors: D
authors: Alvarez
authors: Pramod B
authors: PB
authors: Mahajan
mesh_terms: D056704:Adaptive Immunity / Q000187:drug effects* / Q000502:physiology; D000818:Animals; D000906:Antibodies / Q000032:analysis / Q000276:immunology; D000917:Antibody Formation / Q000187:drug effects; D001688:Biological Products / Q000276:immunology / Q000627:therapeutic use; D004336:Drug Antagonism; D004339:Drug Compounding / Q000009:adverse effects; D004340:Drug Contamination; D006801:Humans; D007136:Immunoglobulins / Q000737:chemistry / Q000276:immunology / Q000627:therapeutic use; D051379:Mice; D004364:Pharmaceutical Preparations; D011506:Proteins / Q000276:immunology* / Q000627:therapeutic use*; D011786:Quality Control; D011994:Recombinant Proteins / Q000276:immunology / Q000627:therapeutic use
chemical_list: D000906:Antibodies; D001688:Biological Products; D007136:Immunoglobulins; D004364:Pharmaceutical Preparations; D011506:Proteins; D011994:Recombinant Proteins