Nexelis has over 15 years of experience in various bioanalytical/immunogenicity assays to support pharmaceutical and biotech industries with large molecules through all phases of assay development/transfer, validation and testing. Nexelis has unrivaled credentials with large soluble molecules.
Our scientists are experienced with diversified scaffolds: full immunoglobulins, bi-specific drugs, peptides, pegylated molecules, enzymes, antibody Fab fragments, nanobodies, etc.
We provide a full range of bioanalytical assays required to take your large molecule candidate from preclinical to clinical programs (Phase I-IV) using state-of-the-art platforms.
Pharmacokinetic Assays (PK)
We can measure your drug during PK studies in various species and in multiple matrices such as serum and plasma. We have a deep understanding of the regulatory expectations and intricacies in developing these types of methods. We will work with you to optimize and validate the assay to be ready for sample testing. Different types of PK formats can be supported from free to total assays with the availability of our expert scientists to consult with you during the reagents generation stage.
Immunogenicity – ADA Assays
Immunogenicity assays are used to detect anti-drug antibodies (ADAs) that specifically bind to the therapeutic protein product. The ADAs are triggered by different factors among them: the drug product itself (molecule structure and post-translational modification, aggregates, formulation, impurities, etc.), the host and the study design (host immune status, genetics, route of drug administration, doses, etc.). ADAs can have non-impactful to life-threatening consequences. Different assay formats (direct, indirect, bridging, etc.) can be developed and validated based on your needs and on the characteristics of the drug product. The bridging assay format is commonly used to detect all bivalent antibody isotypes. The ADA testing is conducted in a tiered approach, where potentially positive samples are detected during screening, and then tested respectively in confirmatory and titration assays. Additional characterization, like isotyping and neutralization testing, can be applied as required.
The aim is to detect low- and high-affinity antibodies with a statistical false positive rate of approximately 5%. The screening assay should be tolerant to free drug and less prone to matrix interference. Antibody isotypes detected are predominantly IgG and IgM and dependent on the route of the drug administration can be IgA and IgE.
Specificity assessment of ADAs against the therapeutic protein product detected during the screening step using a competition method.
The magnitude of ADA response is important, as it can impact the pharmacokinetics, pharmacodynamics, safety, and efficacy of the administered drug.
If necessary, positive samples are tested in a Neutralizing Antibody Assay (NAb), which can either be a ligand-binding assay or a cell-based assay.
ADA-Isotyping and Sub-Classing
Characterization of the ADAs by defining the classes and sub-classes, which is important for life-threatening adverse events.
Various data acquisitions available:
With 30 years of experience partnering with the pharmaceutical and biotech industries, we have optimized study outcomes, accelerated drug development programs, and provided competitive product differentiation in such areas as cardiovascular risk, metabolic diseases, chronic liver disease, drug induced liver injury, acute kidney injury, musculoskeletal, and inflammation. We provide custom assay development, technology platform selection and personalized approach to each project.
Many biomarker assays are readily available at Nexelis. Please scan the menu for your assay requirements.
Biomarker measurements are acquired using various instruments and rely on detection technologies that include ELISA, immunochemistry, chemiluminescence, and electro-chemiluminescence. We offer singleplex and multiplex biomarker assays.
Protein Simple ELLA
Randox Evidence Investigator
Roche Cobas Autochemistry Analyzer e411
Roche Cobas Autochemistry Analyzer c501
Novel Biomarkers Assay Development
Nexelis is constantly expanding its biomarker assay list by developing and validating assays. We provide pharmaceutical and biotech companies with services for testing robust novel biomarkers that have undergone thorough analytical validation and clinical qualification to diagnose early organ injury. Our organ injury panel includes several novel biomarkers that have shown potential to be more sensitive and specific predictors and indicators of kidney and liver injury. Novel biomarkers for assessment of other organs are currently being evaluated and will be added to the menu in the future.
Our experience and reputation in novel biomarkers development positions Nexelis in an ideal situation to support our clients in the development of proprietary biomarkers. We offer proprietary biomarkers development and support to detect early signals of efficacy and segregation of phenotypic sub-populations in precision medicine. Feel free to contact our team to see how our experience can help your company achieve their novel biomarker assay goals.
Safety Biomarker Program
Drug-induced toxicity accounts for 30% of all drug failures prior to reaching the market. The Nexelis Safety Biomarker Program can better identify toxic drug effects that are currently being missed in clinical trials.
The Nexelis Safety Biomarker Program was created in 2008 in response to the FDA-initiated recommendations for streamlining and improving drug development outcomes, as outlined in the Critical Path Initiative through guidance from the Predictive Safety Testing Consortium (PSTC). This Program has a long-standing history and has assessed renal toxicity in 33 drug programs since 2010 and played a critical role in developing and validating the biomarkers that compose the FDA Qualified Composite Measure used to assess renal tubular injury during Phase I clinical trials.