A new article in the journal Nucleic Acid Therapeutics addresses the recognition by the U.S. Food and Drug Administration that immunogenicity assays may be necessary to measure immune responses to ...

The use of biologic-based therapeutics has revolutionized our ability to treat complex diseases such as cancer- and autoimmune-related disorders. Biologic-based therapeutics are known to generate anti ...

Combined with ProImmune’s cell-free HLA-peptide binding assays for more than 50 class II HLA alleles, these new assays enable the creation of a detailed profile of the helper T cell immune response to ...

The assessment of immunogenicity in biotherapeutics is crucial to ensuring both the safety and efficacy of these advanced medicinal products. By detecting anti-drug antibodies (ADAs) and understanding ...

ProImmune Ltd has launched CFSE T cell proliferation assays for immunogenicity risk assessment. The assays form part of ProImmune’s REVEAL Immunogenicity System, a suite of tools used in the design ...

The immunogenicity methods are quasi quantitative as surrogate positive controls are used as assay system suitability. However, the positivity is declared based on the statistically derived screening ...

SAN DIEGO, Dec. 19, 2023 /PRNewswire/ -- Abzena, the leading end-to-end CDMO for complex biologics and bioconjugates, has co-authored a publication with the US Food and Drug Administration (FDA) ...

The forum enables individuals to benchmark their testing and detection strategies against other leading industry professionals, with input from the regulatory authorities allowing you to ensure that ...