Large molecule immunoassay services – Marrietta, GA and Beijing, China
Q2 Solutions offers a full range of services for the development or technical transfer and validation of custom- designed assays and application to study sample testing for PK concentration, immunogenicity and biomarker testing. Ligand binding assays (LBA), typically in the format of immunoassays, are the standard for bioanalytical testing of large molecule drugs. Formats can include use of target, anti-idiotypic antibodies, anti-conjugate, enrichment approaches, and competitive assays depending on drug design and characteristics of the drug and reagents. Platforms including chromogenic ELISA, chemiluminescence, fluorescence and electrochemiluminescence that provide the standard basis for macromolecule drug testing.
Quantitative concentration assays
- PK concentration (Free, Total, Complex)
- Biomarker for analytes that will be used to make regulatory decisions and for label instructions
- Immunogenicity (Anti-Drug Antibody)
- Screen/Confirm/End Point Titer
- Domain Specificity/Isotyping
- Neutralizing (Competitive LBA and Cell-based).
Additional services include critical reagent conjugation and characterization, immunogenicity cut point statistical reports.
ADME Services – Indianapolis, IN
Q2 Solutions helps customers evaluate in vitro properties and in vivo plasma/tissue exposures to optimize ADME properties for potential drug candidates and assess risk associated with metabolism and drug-drug interactions (DDI).
- In vitro permeability of peptides (MDCK II cell line)
- Drug-Antibody Ratio (DAR) estimation for Antibody-Drug Conjugates (ADCs)
- In vitro drug-drug interaction (DDI) risk assessment of oligonucleotides and payload from ADCs
- Discovery level LC-MS bioanalysis of peptides for PK or pharmacology studies
- Biotransformation of peptide and oligonucleotide therapeutics using HRMS