Agilex Pharmacokinetics Services

Liquid Chromatography-Tandem Mass Spectrometry (LC-MS/MS) is a powerful bioanalytical technique that uses liquid chromatography coupled with highly sensitive and selective mass analysis to separate out analytes of interest to enable absolute quantification of the analyte in matrix. Agilex offers State-of-the-Art bioanalysis to support the PK analysis of novel chemical entities (NCEs), sugars, nucleotides, enantiomers, steroids, prodrugs, immunosuppressants, nanoparticles, neurotransmitters, peptides and proteins by LC-MS/MS.

Our dedicated LC-MS/MS team have extensive experience in transferring, developing and validating complex bioanalytical methods across a range of matrices, including plasma, urine, faeces, cerebrospinal fluid, rare and unique matrices (including ocular tissues) in human samples to support PK analysis and across multiple species to support toxicokinetic (TK) analyses for preclinical studies.

Molecularly targeted therapies are the foundation of precision medicine and are the focus of many exciting drug developments. Many therapeutic indications for chemical and biological therapeutics involve interactions of a ligand, chemical drug, protein or antibody with its target. Ligand binding immunoassays harness this power and typically use target, antibodies (commercially available or anti-idiotype) or drug product to build a sandwich immunoassay for quantitation of the analyte of interest.

At Agilex Biolabs, our Scientists have extensive experience across a range of ligand binding assays utilizing different formats and chemistries, including Enzyme-linked immunosorbent assays (ELISA), Electrochemiluminescent assays (MSD-ECL) and Fluorescent assays (Gyros).

New drug modalities such as cell therapies (CAR-T and CAR-NK), gene therapies and cellular/RNA modulator therapies typically utilize polymerase chain reaction (PCR) assays (real-time PCR, droplet digital PCR, reverse transcriptase PCR) or Flow Cytometry assays in order to deliver the PK data to support clinical studies.

Polymerase Chain Reaction (PCR) Assays (qPCR, qRT-PCR, droplet digital PCR)

PCR assays are widely used in cell and gene therapy programs to amplify short oligonucleotide sequences present within a sample. Agilex supports multiple different chemistries (either hydrolysis probe TaqMan chemistry or intercalating dye such as SYBR Green) to enable analysis of your drug or oligonucleotide sequence of interest. We have multiple platforms ranging from conventional PCR to droplet digital PCR to enable single copy number quantification of sequence variants. Our Scientists have experience in supporting PK studies of RNA-based therapeutics, Biodistribution and viral shedding assays for virology or oncolytic virus projects, Gene expression analyses and mutational detection for Ct DNA studies.

New drug modalities such as cell therapies (CAR-T and CAR-NK), gene therapies and cellular/RNA modulator therapies typically utilize polymerase chain reaction (PCR) assays (real-time PCR, droplet digital PCR, reverse transcriptase PCR) or Flow Cytometry assays in order to deliver the PK data to support clinical studies.

Flow cytometry is a powerful tool to enable the quantitation of single cells or particles. The power of Flow cytometry lies in its ability to multiplex different markers on the surface of or internally within a single cell at the same time being able to quantify lineages of cells within whole blood in order to provide profiling and immunophenotyping analyses.

Using state-of-the-art multi-laser flow cytometers, Agilex Scientists can identify changes in cell populations during a clinical study as well as provide PK analysis to quantify cells for adoptive cell therapies or CAR-T/CAR-NK programs; setup up target engagement and receptor occupancy assays and identify granular changes within a single cell in response to treatment.