Expert immunoassay bioanalysis 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 recognized industry leaders in high-performance, regulated immunoassay bioanalysis. Our scientists have over 25 years of 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.
Agilex Biolabs offers state-of-the-art immunoassay and immunobiology services for regulated bioanalysis. Our experienced team can develop or transfer a method for any biologic to support pre-clinical GLP or clinical studies.
Our world-class laboratories feature state-of-the-art equipment including Gyrolab Xplore, MSD Quickplex 120, Luminex Magpix, BD FACSymphony A3 flow cytometer and soon to be released, digital droplet quantitative real-time RT-PCR.
Our scientists have expertise and experience to solve the most complex immunogenicity and drug tolerance issues, often encountered in immuno-oncology studies in both an early phase and later phase setting.
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, organizations, 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: