BioAgilytix has deep expertise in the bioanalytical support needs of autoimmune drug development. By leveraging our team’s veteran insights in autoimmune diseases, our team is set-up to produce successful results in even the most complex studies.
Learn More About Our Autoimmune-Related Experience:
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Autoimmune diseases are chronic and debilitating conditions which are caused by an immune-mediated self-destruction of tissues or organs. The causes are not fully understood but the clinical impact is significant. Diseases and syndromes such as rheumatoid arthritis, Graves’ Disease, or systemic lupus erythematosus are some of the most prominent examples for these pathological findings. Until recently, their symptomatic treatment was mostly based on immune suppressive small drugs. However, novel treatment options are evolving rapidly for this class of diseases. Beyond TNF-alpha inhibition, there are a number of promising biological therapies in the pipeline that are designed to modify the immune response. Moreover, there are drug candidates which may be curative or may prevent the immune hyperreactivity.
Because autoimmune diseases are characterized by polyclonal immune stimulation, these disease entities are more prone to immune responses against biological drugs. Particular care should be taken when assessing the immunogenicity of biological drugs. For instance, anti-drug antibodies may not only lead to a loss or reduction of efficacy, but also to an unobserved clinical latent progression of the autoimmune disease. In addition to measuring ADA and NAb, controlling the PK and the analysis of specific biomarkers are extremely important to monitoring patients. Hence, pharmaceutical and biotechnology companies involved in autoimmune drug development will need an effective CRO partner, that has significant bioanalytical and clinical expertise and knowledge in this complex space, to ensure the highest quality results.
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Today’s pharmaceutical and biotechnology organizations need a scientific partner that can help them constantly innovate and evolve to meet novel requirements of developing increasingly effective (but increasingly complex) biotherapeutic innovations.
Autoimmune-related drug development is a true area of expertise for BioAgilytix. This is reflected in the comprehensive services we provide spanning from discovery through Phase I, II, II and IV. Throughout the study, our GLP/GMP lab confirms that assay data supports the requirements of regulated bioanalysis.
Our scientists are constantly expanding their expertise in all autoimmune disease states. However, we have specific expertise analyzing compounds and biotherapeutics that target conditions including in lupus, inflammation discovery, rheumatoid arthritis, and respiratory diseases.
The following services are regularly used in autoimmune-related studies at BioAgilytix:
Biomarkers
Immunogenicity
Pharmacokinetics (PK)
Cell-Based Assays
Our autoimmune-related services are carried out using a specialized selection of state-of-the-art technologies and platforms that are designed to improve the quality of an autoimmune study’s process and data. BioAgilytix is well versed in the bioanalytical support needs of autoimmune drug development. Our expert scientists strategically implement the best-fit technologies to overcome your autoimmune project’s most challenging barriers. A sample of the platforms we typically leverage is featured below:
ELISA
MSD-ECL
Gyrolab
Luminex
Flow Cytometry
(FACS Analysis)
ProteinSimple Ella
LI-COR Odyssey
qPCR
Explore our array of white papers, articles, and videos to gain deeper insight into our large molecule expertise, and to stay updated with the latest news and research coming from the field of bioanalysis.
To continue innovating, we understand that pharmaceutical and biotechnology companies are in need of a CRO partner that can help develop safer, more effective biotherapeutic solutions for inherently complex autoimmune diseases.
BioAgilytix is an experienced provider of autoimmune disease-related bioanalytical services that are supported by deep scientific expertise and advanced technology. Our scientists have decades of experience that have contributed to producing the most accurate and comprehensive scientific results possible in various autoimmune matrices including plasma, serum, BAL, sputum and synovial fluid. In fact, BioAgilytix has more than 30 validated assays for autoimmune conditions.
Look to BioAgilytix for an expert partner to support your autoimmune studies from discovery through to Phase IV.
See how our PK expertise complements our immunogenicity services by evaluating absorption, distribution, metabolism and excretion characteristics of a product.
Learn how we will translate our experience working with over 500 biomarkers in singleplex and multiplex formats to your project’s success.
Services
Platforms