A pharmacokinetic (PK) assays evaluate how the body affects a specific substance after administration which includes: absorption, biodistribution, metabolism, and excretion. Preclinical (or non-clinical) PK assays play a crucial role in drug development and typically focus on assessing drug safety and maximum tolerable dose. For the development of pre-clinical PK assays, it’s important to focus on the upper range of the assay, and less on sensitivity. While sensitivity is always an important factor of any assay, it’s not the focus of these assays.

Generic LBA PK assay, also referred to as a universal PK assay, is used early in drug discovery to provide support of monoclonal antibodies (mAbs) and antibody-drug conjugates (ADCs) in animal studies when specific reagents such as anti-idiotype antibodies are not yet available. They are referred to as generic assays since they use anti-human IgG antibodies for capture and detection. This assay can be used to evaluate more than one drug candidate or in some cases multiple drugs that are similar. Typically, these generic assays use two monoclonal antibodies that bind to unique epitopes in the Fab region of the human IgG. Many commercially available antibodies can be used as capture/detection reagents in a universal Ligand Binding Assay (LBA) format. Due to the versatility of these reagents, generic assays can be quickly and inexpensively developed to support testing human antibodies in many animal matrices. 

Key Characteristics of generic LBA PK assay:

  • Adaptable – the generic PK assay can be adapted to most mAbs and ADCs. 
  • Rapid Development time – generally only a few days of method development are required before sample analysis.
  • Broad assay range with good sensitivity – extended assay range allows for good sensitivity without sacrificing the upper end of the assay.

While there are many benefits to using a generic PK assay there can be challenges with the development of these assays. The generic PK assay is susceptible to high background, which affects sensitivity and selectivity due to interference/matrix effects and can be a challenge in these assays. However, KCAS Bio has an experienced team of scientists that understand these challenges and have a vast amount of experience with not only developing, but also troubleshooting these assays to minimize these encounters.

KCAS Bio has developed many generic PK assays over the past several years.  The LBA team has expertise in this space and can help you quickly develop a generic PK assay that can be used to test multiple candidates for drug candidate selection. KCAS Bio has developed generic PK assays that have been adapted to rats, mice, and non-human primate matrices to name a few.  Generic PK assays can be used to accelerate drug development in the preclinical space leading to not only cost savings in assay development but providing reliable data quickly to assist you with moving into the next phase of drug development.