Bioanalysis of Biological Drugs & Biosimilars
Kymos offers bioanalytical services for a wide range of biological drugs from preclinical and clinical studies, including innovative proteins, biosimilars, therapeutic peptides and enzymes, biomarkers, monoclonal antibodies, hormones, nucleic acids and other large molecules. We are a GLP-certified and GCP compliant multinational CRO with broad experience in method transfer, regulatory validations and the development of challenging bioanalytical methods for biological drugs from scratch. We are equipped with state-of-the-art analytical tools such as ELISA, ECLA, RIA, HPLC-MS/MS tryptic digestion and routine work includes drug levels and PK/PD calculations, immunogenicity assays including ADAs’ binding and neutralizing assays. Our team can support you in the following areas:
• Preclinical studies
• PK (pharmacokinetics) and PD (pharmacodynamic) calculations and statistics
• Metabolite identification and quantitation
• Toxicokinetics of biological drugs
• Clinical studies
• Phase I-IV pharmacokinetics including first-in-man dose escalation studies
• Biological drug – drug interaction studies
• Immunogenicity assays
• Enzyme activity determination
• Bioanalysis of nucleic acids
Preclinical and Clinical Bioanalysis of Biological Drugs
Kymos bioanalytical offer for the quantification of large proteins is based on multiple immunological techniques. Owing to our broad know-how in both small and large molecules, method development by mass spectrometry with triple quadrupole and QToF mass spectrometers is used to measure proteins and peptides as well as related biomarkers. Different platforms are available depending on the molecule:
• ELISA: direct, sandwich, bridge or competitive using different detection techniques such as colorimetric, fluorescence, time resolved fluorescence .
• Electrochemiluminescence (ECLA) by high-throughput Meso Scale Discovery (MSD®)
• HPLC-MS/MS: tryptic digestion of the protein and signature peptide quantification
• UV-Vis enzyme activity quantification
KYMOS full development service also includes the in-house production of polyclonal antibodies and labelled reagents necessary for the assays.
Novel biological drugs have the potential to induce immune responses which can impact on pharmacokinetics, efficacy, safety and cross-react with endogenous molecules. KYMOS provides comprehensive services to test the immunogenicity of biological drugs:
- Determination of binding Anti-Drug Antibodies (ADA) against peptides, proteins or antibodies using ELISA, ECLA or Surface Plasmon Resonance (SPR) (Biacore®):
- Screening assays for the detection of positive samples
- Confirmatory assays to rule out false positives
- Titration assays for immuno response quantification
- Isotyping assays to identify ADA isotypes
- Neutralizing assays to assess ADA drug function inhibition capabilities using several alternative approaches:
- Cell-based assays (CBA)
- Binding assays using ELISA, ECLA or Surface Plasma Resonance (SPR) (Biacore®)
PK and PD calculations and statistics of biological drugs
We have decades of experience providing pharmacokinetic, pharmacodynamic, toxicokinetic calculations and statistics with Phoenix WinNonlin® for bioanalytical data coming from preclinical and clinical studies of biological drugs. Please find more information on our service page Pharmacokinetic Evaluation & Statistics.
Nucleic acids are biologics, but their analytics are very specific. Wea dedicated team supporting GLP nucleic acid bioanalysis in preclinical toxicokinetic, pharmacokinetic studies and clinical trials. You can find more information on our service page Bioanalysis of Nucleic Acids.
DETERMINATION OF ENZYME ACTIVITY
Besides quantification and immunogenicity of biological drugs Kymos provides enzyme activity assays under GLP/GMP conditions in both bioanalytical and CMC projects for natural and engineered enzymes, enzymatic biomarkers and enzyme inhibitors in biological and formulation samples. You can find more information on our service page Enzyme Activity.
Why choose KYMOS to support your bioanalytic needs for biological drugs and biosimilars
We are FDA and EMA inspected, GLP-certified and fully compliant with EMA guidelines on Clinical Investigation of the Pharmacokinetics of Therapeutic Proteins among other FDA regulations. We are the preferred partner to multiple innovators for biological drugs and biosimilar developers worldwide. Bioanalysis of biological drugs requires more development work than small molecules and our expert team has decades’ worth of experience transferring, validating and developing challenging methods with complex large molecules. Moreover, our complementary know-how in small and large molecules allows us to combine mass spec and immunogenicity services in projects involving immunogenic peptides or small molecules and their related biomarkers.