Creative Biolabsis an experienced expert on ADA assay development and validation. We strive to accelerate the development of your new drug candidate from preclinical to clinical stage and eventually to the market. Our SIAT® anti-drug antibodies assay services...
Immunogenicity testing is an essential step in therapeutic protein drug development process. Anti-Drug antibodies (ADA) may lead to many clinical problems including allergic reactions, altered pharmacokinetic, reduced efficacy, etc. Thus, immunogenicity testing to evaluate the ADA level induced by ...
Provided is a method for more simply and accurately measuring ADAs that develop in a patient receiving drug-based, molecular-targeted therapy, or the like. This assay method for ADAs in an assay sample includes the following steps (1) to (4). (1) A step for preparing a specimen which ...
Anti-drug antibodies may also increase the risk of hypersensitivity reactions by the formation of immune complexes. Furthermore, by cross-reacting with the endogenous homolog of the drug, the anti-drug antibodies might impair important physiological functions even after treatment cessation. As a ...
Results from an analysis of the phase 3 HIMALAYA trial (NCT03298451) showed did not show anti-drug antibodies (ADAs) to have an effect on the efficacy or safety of durvalumab (Imfinzi) alone or the STRIDE combination of durvalumab plus tremelimumab (Imjudo) in patients with u...
Evolving immunogenicity assay performance expectations and a lack of harmonized anti-drug antibody validation testing and reporting tools have resulted in
We analyzed the cross-reactivity of anti-drug antibodies (ADAs) against agalsidase-alfa and -beta from 49 patients with Fabry disease (FD) against the novel PEGylated enzyme pegunigalsidase-alfa (PRX-102). The affinity of purified anti-AGAL antibodies from pooled patient sera was significantly ...
Twenty percent of baseline patient samples exhibited a pre-existing response in a bridging anti-drug antibody (ADA) assay for a human IgG4 monoclonal antib
Case Study of PK Assay Development Bispecific drugs have two different specific antigen-binding sites that can bind to two antigens or two epitopes simultaneously. Sino Biological has successfully produced competitive and non-competitive anti-idiotype antibodies against two targets of a bispecific drug....
Antibodies sequenced for long-term security of supply Readily integrated downstream antibody drug PK/PD and immunogenicity assay Anti-idiotype Antibody Production Packages Anti-idiotypic antibodies that recognize an antigen-combining site of an antibody can mimic the structure and/or function of certain ...