By a News Reporter-Staff News Editor at Drug Week -- A new study on Immunology is now available. According to news originating from Thousand Oaks, California, by NewsRx correspondents, research stated, "Immunogenicity testing during early biotherapeutic development is usually limited by resources needed for assay development, validation, and the necessity for unique product-specific controls and reagents. We describe a unique immunoassay [universal indirect species-specific assay (UNISA)] that can be applied during early phase preclinical studies to support pharmacology, pharmacokinetics (PK), and toxicology evaluation during biotherapeutic antibody candidate assessment."
Our news journalists obtained a quote from the research from Amgen, "UNISA was evaluated across three animal species: mouse, rat, and cynomolgus monkey. For each species, a unique and specific antibody pair was generated consisting of the secondary antibody and the positive control. The secondary antibody is specific for species anti-IgG antibody while demonstrating no cross-reactivity to human antibody-based biotherapeutics. The positive control is comprised of a species-specific anti-human IgG antibody clone specific for binding to the CH2 domain of all human IgG subtypes. Applications of this platform included: (a) identifying the dose with the least immunogenicity risk; (b) characterizing the impact of immunogenicity on PK exposure profiles across multiple antibody candidates and dose regimens; and © characterizing the immune response specificity to the idiotype or non-idiotypic region of the biotherapeutic candidate. Due to its use of universal species-specific reagents, UNISA can overcome resource constraints and avoid extensive validation and development time to support immunogenicity testing during the early research and preclinical phase of programs."
According to the news editors, the research concluded: "Enhanced understanding of the impact of the immunogenicity on biotherapeutic exposure and target-related immunomodulatory effects have been made possible with the use of this assay."
For more information on this research see: Universal immunoassay applied during early development of large molecules to understand impact of immunogenicity on biotherapeutic exposure. The Aaps Journal [electronic Resource], 2012;14(4):843-9. The Aaps Journal [electronic Resource] can be contacted at: Springer, 233 Spring Street, New York, NY 10013, USA (see also Immunology).
The news correspondents report that additional information may be obtained from A.C. Bautista, Clinical Immunology Department, Amgen Inc, One Amgen Center Drive, MS 30E-3-B, Thousand Oaks, California 91320, United States. Additional authors for this research include H. Salimi-Moosavi and V. Jawa.
The publisher's contact information for the The Aaps Journal [electronic Resource] is: Springer, 233 Spring Street, New York, NY 10013, USA.
Keywords for this news article include: Antibodies, California, Immunology, Thousand Oaks, United States, Blood Proteins, Immunoglobulins, North and Central America.
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