Smithers supports the development of large-molecule therapeutics from discovery through phase IV, with expertise in bioassays and ultra-sensitivity ligand-binding assays. The services focus on development, validation and sample analysis for PK/TK, ADA, bioassays and fit-for purpose biomarker studies. Smithers supports biologics/monoclonal & polyclonal antibodies/bi-specific antibodies/CAR-T/TCR/biosimilars and biobetters.
Smithers supports the bioanalytical development of a wide range of therapeutics including CAR-T/TCR and other cellular therapeutics, monoclonal and bi-specific antibodies, fusion proteins, biosimilars/biobetters, among many other large-molecule drugs. We operate as a full service GLP/GCP and CLIA contract research organization.
Our senior staff averages 15+ years of experience in method development and method validation of PK/TK assays, anti-drug antibody assays (ADA), neutralizing antibody (NAb) and other cell-based assays as well as fit-for-purpose biomarker assays. Many of our subject matter experts have been involved in clinical trial studies that have led to the approval of biologics by regulatory agencies. All of our instrumentation is connected to our Watson 7.4 LIMS system for QC and data security.
Smithers has extensive experience with assays for both pre-clinical applications and all phases of clinical development, phase I through phase IV. The laboratory is both GLP and CLIA.
Our assay services include the following: