When it comes to developing new therapies for inflammatory bowel diseases (IBD), having robust and reliable bioanalytical support is crucial. From the early stages of drug discovery to Phase III clinical trials, our comprehensive bioanalytical solutions are designed to enhance and accelerate your drug development journey in a GCP and GLP-compliant environment. We offer a wide range of services to meet your bioanalytical requirements, ensuring precision and regulatory compliance throughout the entire process.
Below are the critical bioanalytical strategies we implement to support each stage of your IBD drug development.
1. Pharmacokinetics (PK)
Understanding how your drug behaves in the body is critical. We specialize in developing and validating regulatory-compliant PK assays that evaluate drug concentrations in both human and animal samples. Whether through LBA, LC-MS/MS, or hybrid LC-MS/MS techniques, we ensure precise pharmacokinetic analysis to guide your development process.
2. Immunogenicity Testing
One of the key concerns during the development of biologic therapies is whether they induce anti-drug antibodies (ADA). Our multi-tiered approach to immunogenicity testing helps identify potential immunogenic responses, including the evaluation of neutralizing antibodies. We offer LBA and hybrid LC-MS/MS methods to assess immunogenicity accurately.
3. Immune Cell Profiling
How does your drug impact the immune system? We provide advanced immune cell profiling services, using validated panels to detect and characterize B-cell and T-cell subsets in human PBMC samples. Our flow cytometry expertise ensures a thorough understanding of how your drug affects immune cell subpopulations and their activation status.
4. Soluble Biomarkers
To assess the efficacy of your drug, it’s crucial to measure biomarkers associated with disease mechanisms. We can quantify a wide range of biomarkers, including those related to inflammatory and immune regulation (such as soluble CD14, IL-6, TNF-a, IL-1b, CCL-2/MCP-1, IL-10, TGF-b, and others), metabolic biomarkers (like adiponectin), and intestinal permeability markers (such as zonulin). Our bioanalytical techniques, including LBA and LC-MS/MS, ensure precise biomarker quantification to evaluate drug efficacy across multiple categories, aiding in the comprehensive understanding of IBD therapies.
5. Multiple Modalities
Our expertise covers a wide range of therapeutic modalities, including monoclonal antibodies, small molecules, peptide hormone therapies, and corticosteroids. We offer bioanalytical services tailored to various drug types, ensuring the best support for your IBD therapy development.
6. Multiple Matrices
The choice of sample matrix is crucial in bioanalysis. We work with a variety of biological matrices including whole blood, plasma/serum, PBMC, urine, fecal samples, and tissue biopsies. Our services span across multiple species, including rodents, non-human primates, and humans, ensuring accurate and reliable data for pre-toxicology, GLP pre-clinical, and GCLP clinical studies.
Our bioanalytical solutions support your drug development from discovery to Phase III trials, offering expertise across monoclonal antibodies, small molecules, and peptide hormones, ensuring regulatory compliance and robust data at every step.