Pharmacokinetic and Immunogenicity Assay Development
EVIOGEN DISCOVERY supports the development of large molecule therapeutics from pre-clinical discovery through clinical studies, with expertise in bioassays and ultra-sensitivity ligand-binding assays. The services focus on development, validation and sample analysis for pharmacokinetic (PK), immunogenicity (ADA) and custom bioassays. EVIOGEN supports peptide/monoclonal & polyclonal antibodies/bi-specific antibodies/CAR-T/biosimilars and biobetters PK and ADA studies.
Our scientific team has strong experience in method development and method validation of PK assays, anti-drug antibody assays (ADA), neutralizing antibody (NAb) and other cell-based assays.
Our assay services include the following :
- Method Development
- Method Transfer
- Method Optimization
- Method Validation
- Sample Analysis
Supporting :
- Peptide and other biologics
- Monoclonal/Polyclonal Antibodies
- CAR-T/TCR
- Bi-Specific Antibodies
- Biosimilars/Biobetters
Immunogenicity Assay Development
Anti-drug antibodies (ADAs) may occur as an organism's response to a biotherapeutic during treatment, a process also known as undesirable immunogenicity. ADAs harbor the risk of mediating undesirable biological or physiological effects, either by inhibiting the therapeutic molecule’sefficacy of the treatment itself or by inducing adverse toxicological events.
EVIOGEN offers the development of an immunogenicity assay (ELISA) for screening of anti-drug antibodies in serum samples by using a bridging ELISA. In this set-up the ADA establishes a molecular bridge between the labeled drug antibodies.Assay development and validation are conducted according to the FDA & EMA guidelines.
Approximate project duration: 25-30 weeks
Pharmacokinetic Assay Development
The assessment of drug efficacy and safety is of major concern in the pre-clinical and clinical phases of biologics drug development. liberation, absorption, distribution, metabolism and excretion (LADME), the pharmacokinetic parameters of a pharmacologically active substance need to be monitored continuously. PK assays are used to determine the concentration of the drug in a patient’s sample (e.g. plasma or serum) at given times. Regulatory authorities (the EMA and FDA) have released several guidelines for how these issues should be addressed using in vitro studies.
EVIOGEN has optimized PK assays for different biologic molecules through sandwich ELISA method. The therapeutic drug is successively captured and detected by two monoclonal antibodies, in a layered fashion.Monoclonal anti-IDs are routinely used as capture and detecting reagents in pharmacokinetic (PK) assays for the quantification of antibody drugs in patient serum.
We have developed and validated methods for following molecules :
- Etanercept
- Adalimumab
- Rituximab
- Trastuzumab
- Infliximab
- PEG-EPO
- PEG-GCSF
- Liraglutide
- Interferon alpha-2b
- Bevacizumab
- FSH
- Luteinizing hormone (LH)
- Streptokinase (SK)