Pharmacokinetic and Immunogenicity Testing
Pharmacokinetic and Immunogenicity Testing

The Importance of Pharmacokinetic (PK) & Immunogenicity Testing

The assessment of drug efficacy and safety is a major concern in the pre-clinical and clinical testing phases of biologics drug development. Regulatory authorities (the EMA and FDA) have released several guidelines for how these issues should be addressed using in vitro studies. 

Our experts understand the difficulties and complexities that need to be addressed in your studies and will help you determine the optimal approach for immunogenicity and PK testing. 

To provide you with a complete service, BioGenes works closely together with FyoniBio. By combining our scientific expertise, we can offer you an all-in-one package ranging from custom antibody and assay development to ELISA validation and the analysis of pre-clinical and clinical samples according to GCLP guidance. It also remains possible to obtain the individual services of both companies.


Pharmacokinetic Assays and Testing

As suggested by the “LADME” scheme, the distribution, metabolization and elimination of a pharmacologically active substance needs to be monitored.

The Sandwich ELISA is BioGenes' preferred approach to PK assays. This means that the therapeutic drug is sequestered by two monoclonal antibodies, one as capture and one as detector antibody in a layered fashion.

Overview of PK Assay Services

  • Development of monoclonal anti-drug-antibodies and pair search
  • Selection of the most suitable antibody pair and characterization in matrices
  • Production of the selected antibodies in sufficient quantities
  • Transfer of the assay method to FyoniBio or the customer's preferred CRO
  • At FyoniBio: Assay establishment on MSD platform (preferred platform) and validation
  • At FyoniBio: Analysis of samples (GCLP)

Immunogenicity Assays and Testing

Anti-drug antibodies (ADAs) may occur as an organism's response to a therapeutic protein drug during treatment, a process also known as unwanted immunogenicity. ADAs harbor the risk of mediating unwanted biological or physiological effects, either by inhibiting the therapeutic effect of the treatment itself or by provoking adverse events.

The immunogenicity assessment of a therapeutic drug also involves the use of anti-drug antibodies or anti-idiotypic antibodies as positive assay control. Since the thorough examination of the occurrence of ADAs in patient samples is particularly challenging, a multi-step approach is currently recommended by regulatory authorities.

Overview of Immunogenicity Assay Services

  • Development of polyclonal antibodies (pAb) as positive control
  • Labeling of the drug
  • Selection of the pAB batch and assay design in bridging format
  • Transfer of the assay method to FyoniBio or the customer's preferred CRO
  • At FyoniBio: Assay establishment on MSD platform (preferred platform) and validation
  • At FyoniBio: Analysis of samples (GCLP)