IMMUNOASSAY BIOANALYSIS OF LARGE MOLECULES

Our Platform Suite

LC – MS/MS Bioanalysis

Immunoassay Bioanalysis

Biomarkers

Meso Scale Discovery Platform

Gyrolab Platform

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Expert immunoassay bioanalysts and world-class equipment

Molecularly targeted therapies are the foundation of precision medicine and are the focus of many exciting drug developments.

Agilex Biolabs are recognised industry leaders in high performance, regulated immunoassay bioanalysis of large molecules. Our scientists have over 10 years experience in developing and validating robust compliant PK, PD and Immunogenicity assays to support preclinical and clinical programs.

Targeted biological therapies pose huge bioanalysis challenges in a clinical setting and most adverse reactions are derived from humoral immunologic responses via the generation of anti-drug antibodies (ADAs). The immunogenicity (ADA- response) of a biologic drug is paramount to its safety and efficacy.

Determining the Immunogenicity of a drug with timely and highest quality data is critical to drug development. At Agilex Biolabs, immunogenicity, ADAs, NAb assay can be developed and validated to stringent regulatory standards using the most advanced technologies. Our areas of expertise include: recombinant proteins, monoclonal antibodies, fusion proteins, biosimilars and biobetters.

​Biosimilars

As the number of biologic medicines going off patent increases, biosimilar medicines, the identical copies of licensed biologic medical products, are increasing.

Biosimilars promise to be cost effective alternatives for healthcare practitioners, organisations and patients alike by providing affordable versions of already-marketed biologics. For biosimilar approval by regulatory authorities, comparison testing against the reference innovator product is required.
At Agilex Biolabs, we have experience in developing and validating a range of biosimilars that are targeted to various disease indications and successfully testing these against both US and EU-derived innovator compounds in clinical studies, including:

OriginatorBiosimilarTargetAssay
PKADAPD
Lucentis®RanibizumabVEGF-AXXVEGF
Forsteo®TeriparatidePTH1 receptorXX
Avastin®BevacizumabVEGF-AXXVEGF
Actemra®TocilizumabIL-6 receptorXX
Xolair®OmalizumabIgE FcXXIgE
Herceptin®TrastuzumabHER2/neuXX

Assay development

Our immunoassay team are experts at developing robust, compliant assays to characterise novel compounds, including:

  • Biomarkers
  • Immunogenicity
    • Antidrug antibody (ADA)
    • Neutralising antibody detection (NAb – competitive ligand binding)
  • Pharmacokinetic (PK) bioanalysis
  • Pharmacodynamic (PD) biomarker analysis

​Assay validation

Our immunoassay team are experts at full and partial validation and method transfer to ensure data integrity, validity and reliability.

Sample analysis

Our laboratory platforms perform high throughput and high performance sample analysis, including:

  • Immunogenicity
    • Antidrug antibody (ADA)
    • Neutralising antibody detection (NAb – competitive ligand binding)
  • Pharmacokinetic (PK) bionalaysis
  • Toxicokinetic (TK) analysis

LC-MS/MS Bioanalysis

Immunoassay Bioanalysis

Biomarkers

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