Agilex Pharmacodynamics Services
Pharmacodynamics (PD) is the study of the biochemical, physiological and molecular effects of a therapeutic on the body. PD assessments provide vital information on the receptor binding, pathways, genes, RNA and proteins modulated by therapeutics during a clinical or preclinical study, providing vital efficacy assessments to help investigators refine and optimize dosing schedules to achieve therapeutic effectiveness.
PHARMACODYNAMIC
At Agilex Biolabs, we have extensive experience across a range of assays and platforms to enable sponsors to assess the effects of their therapeutic on the immune system (immunogenicity, immune cell modulation, immunophenotyping, proliferation, activation and receptor occupancy), cellular biomarkers (cytokines, chemokines and other inflammatory markers) and molecular markers (DNA and RNA). Our Pharmacodynamics services include:
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Immunogenicity
Immunogenicity refers to the ability of a biotherapeutic to induce a humoral or cellular immune response. These responses can either be desirable, such as those generated by vaccines which are designed to provide a protective immune response, or undesirable in the case of anti-drug antibodies, which can bind to the therapeutic and promote its clearance thereby reducing its efficacy.
Scientific Expertise
The Agilex Scientific team have a deep understanding of immunogenicity assessment for biologics, with an in-depth knowledge of developing and validating drug and target tolerant assays to meet the needs of the study and in accordance with the latest regulatory requirements (EMA and FDA). Experience across ELISA and MSD platforms, including standard bridging assays (with and without acid), solid phase extraction with acid dissociation, affinity capture elution assay formats and precipitation and acid dissociation assays for oncology studies requiring high drug and target tolerance.
Agilex offers a comprehensive tiered approach for immunogenicity assessment, including:
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Vaccines
Agilex offers a comprehensive suite of services to support vaccine development, including customized immunoassays, molecular and flow cytometry assays that support the advancement of novel vaccine studies.
Scientific Expertise
The Agilex Scientific team have a deep understanding of antigen-antibody responses and developing, qualifying and validating custom vaccine-specific immunoassays (ELISA/MSD) to detect vaccine-specific antibodies, antibody subtyping, ELISpot enumeration of specific T-cell and B-cell responses, customized cell based assays, neutralizing antibody assays and molecular assays.
Assays supported
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Cell Based Immunology Assays
Agilex offers a comprehensive suite of solutions for immunology, including ELISpot, flow cytometry, proliferation, activation, cytokine release assays and customized cellular and molecular assays to inform the pharmacodynamics of the drug discovery program.
ELISpot
ELISpot is widely used in preclinical and clinical immunological assessments due to its high sensitivity, specificity, and ability to detect rare immune cell responses. The assay quantifies antigen-specific T-cell or B-cell responses by capturing secreted cytokines or antibodies. This capability is crucial for assessing the mode of action, efficacy and safety of new therapeutics, especially in immuno-oncology, vaccine development, and autoimmune disease treatments.
At Agilex, ELISpot is frequently employed in different stages of clinical trials to assess immune responses therapeutics by measuring the number of cytokine-secreting cells in PBMCs or whole blood at a single cell level.
Assays Supported
Vaccines
In vaccine trials, ELISpot is used to measure antigen-specific B-cell or T-cell responses, providing early indicators of immunogenicity and potential protective immunity.
Autoimmune Disease Monitoring
In autoimmune diseases, ELISpot assays detect aberrant immune activation and assess the efficacy of immunosuppressive or immunomodulatory drugs.
Magnetic Bead-Based Cell Sorting
Magnetic bead-based sorting relies on antibodies conjugated to magnetic beads that selectively bind to surface markers of target cells. A magnetic field is then applied to separate labeled cells from the rest of the population. This method allows for the enrichment of highly specific immune cell subsets, such as CD4+ and CD8+ T cells, B cells, monocytes, and dendritic cells.
Immuno-Oncology
For cancer immunotherapies, such as checkpoint inhibitors and adoptive T-cell therapies, ELISpot helps in determining whether a patient’s immune system is capable of mounting an effective response against tumor antigens.
Isolation of Immune Cells Using Magnetic Sorting Beads
To perform ELISpot effectively, high-purity immune cells are required. Magnetic-activated cell sorting (MACS) is a widely used method for isolating discrete immune cell populations from whole blood or peripheral blood mononuclear cells (PBMCs). The use of magnetic sorting beads enables rapid, high-yield, and high-purity isolation of specific immune subsets, ensuring accurate downstream functional analyses.
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Flow Cytometry
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 critical PD assays, including cell phenotyping, target engagement and receptor occupancy assays and identify granular changes within a single cell in response to treatment.
Scientific Expertise
Our Scientists have published extensively in the areas of inflammation and immunology using flow cytometry and have extensive expertise and experience across multiple assay types (cellular proliferation and activation assays, receptor occupancy assays and immunophenotyping assays) to develop and validate custom fit for purpose assays based on your needs.
Dedicated Flow Cytometry Laboratories in Australia for Fast Turn Around of Data
With dedicated Flow Cytometry laboratories co-located within dedicated Phase 1 units as well as at our Headquarters in Adelaide, Australia, Agilex can support real-time sample processing and flow cytometry analysis.
Experience
Flow Cytometry
Our flow suite houses BD FACSymphony and Cytek Aurora flow cytometers. The IB team has extensive in-house experience and deep immunological knowledge essential for developing bespoke flow cytometry assays including panel design for phenotyping including intracellular targets, receptor occupancy, phospho flow and proliferation assays. We analyse whole blood, PBMC or specific populations isolated by magnetic beads.
PCR
Our genetic suite houses real time and digital PCR capabilities combined with robotic extraction and plate loading equipment for high throughput. The IB team has broad experience understanding genetics and with all forms of PCR including digital PCR, mutation detection, absolute quantitative and relative real-time PCR for both mRNA and DNA targets in clinical samples including blood, urine and saliva, and across the majority of tissues from different species in GLP pre-clinical studies.
State-of-the-Art Equipment
Agilex is equipped with state of the art Flow Cytometry platforms, including BD FACSymphony A3 Systems (five-laser) and Cytek Aurora spectral cytometers (three-laser), enabling flexibility in high-dimensional multiparameter analysis, high-resolution data acquisition, exceptional sensitivity, and rapid sample processing.
Assays Supported
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World class technology
Over 28 years of experience in developing and validating robust compliant immunoassay, immunogenicity, and cell-based assays to support nonclinical and clinical programs.
Experts in overcoming bioanalytical challenges from new chemical and biological entities.
Agilex offers a wide range of kit productions and logistics services to explore
Supporting non-clinical through to early/late-phase clinical programs through our state-of-the-art, custom-built GLP facilities.
Determine key insights into a therapeutic’s efficacy, safety profile, and mechanism of action.
