We offer customized end-to-end bioanalytical solutions to achieve your milestones effectively and on schedule, supporting the development of a wide range of therapeutics from discovery through Phase IV. We have a solid foundation of experience in standardized and customized development, validation, and production of pharmacokinetic and immunogenicity assays for biosimilars, biobetters, and new biological entities (NBEs).

Assessment of the immunogenicity of therapeutic drugs becomes particularly important when considering the significance of anti-drug antibodies (ADAs) in clinical studies. Our customizable panel of assays is developed via thorough method development and validation processes to ensure every assay meets all regulatory and sponsor-specific requirements and provides useful, clinically relevant data to facilitate the progression of your therapeutic pipeline.

Our pharmacokinetic (PK)/pharmacodynamic (PD) assays are recognized throughout the industry for their sensitivity and specificity. We work with you to customize these assays to develop and validate them according to your precise requirements. Our assays are compatible with sample material from an extensive array of matrices and are suitable for both preclinical and large-scale, high-throughput clinical studies.

Other capabilities include:

  • Dose response, safety, and efficacy assessments
  • MSD discovery assays
  • Chemiluminescence assays
  • Receptor occupancy assays
  • Analysis in a wide range of biological matrices

At Inotiv, we use innovative, industry-proven, and trusted technology platforms to ensure we provide you with the best data for your program:

  • ELISA testing
  • Meso Scale Discovery
  • Cytometric bead array (clinical)
  • Nephelometry (clinical)
  • Fluorescence and luminescence-based assays
  • Protein arrays