Immunoassay Services

Antibody and Immunoassay Consultants (AIC) provides our clients with assistance in feasibility, design and optimization of their immunoassays. With over 25 years of immunoassay development experience, our staff can provide technical and quality expertise to aid our customers in the implementation of assays to be performed in the client’s laboratory, at AIC or to be transferred to a third party. AIC is an economical choice for preclinical and phase I studies when validated assays are not required and assay development is in its early stages.


Assay Design

In consultation with our clients, AIC will develop and optimize protocols for assays needed to measure immunogenicity, pharmacokinetics and anti-drug antibodies. For assays performed at the client’s laboratory or at a third party laboratory, AIC personnel can review data and suggest optimization strategies, if necessary.


When a client selects AIC to develop their assays, these services are provided at a lower cost and more efficiently than the same project at a traditional CRO. AIC can perform feasibility testing and assay optimization in our own laboratories. Our processes include optimization of all assay components, including (but not limited to) coating antigens/antibodies, detection antibodies, blocking reagents, and plastics. A variety of formats (sandwich, indirect, competitive inhibition) may be used in order to provide with most accurate and robust assay possible.


AIC can provide data on isotype distribution in serum samples and measure cytokine responses in serum, plasma or cell culture supernatants. Our services also include cell-based assays to measure the efficacy of antibodies in response to vaccine candidates or to measure the functionality of anti-drug antibodies.


Assay Transfer

Our goal is to establish assays that are well-characterized, fully documented and ready to be transferred to traditional, GLP/GMP-compliant CRO’s for use in pre-clinical or clinical trial sample analysis with minimal modifications or down-time.


Identification of CRO for Assay Validation, Phase II and Phase III Clinical Trials

Through our extensive network of contacts AIC will identify GLP/GMP compliant CRO’s well-suited for our client’s specific needs. If requested, AIC personnel can provide a pre-study audit.


Study Management

If requested, AIC personnel can provide program management for any study. Our services include pre-study, in-life and post-study on-site audits, review of data (both in-life and post-study), regular meetings with the CRO, weekly or bi-weekly updates to the client, problem resolution, review of final report and site visits as required.