Kymos Group 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, HPLC-MS/MS tryptic digestion and routine work includes drug levels and PK/PD calculations, immunogenicity assays including ADAs’ binding and neutralizing antibodies.
Services
Our catalog of services for biologics & biosimilars include:
SERVICES
Bioanalysis Studies for Biologics
Preclinical and Clinical Bioanalysis of Biological Drugs
Our bioanalytical service for the quantification of large proteins is based on multiple immunological techniques. Our different platforms include:
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 with Tryptic digestion of the protein and signature peptide quantification
UV-Vis enzyme activity quantification
We also provide full-service assay development, including production of antibodies for ligand binding assays and labeled reagents.
Our different platforms for Biological Drugs analysis combined with our know-how in both small and large molecules, enable us to comply with a broad spectrum of methods also including mass spectrometry with triple quadrupole and QToF mass spectrometers to measure proteins, peptides and biomarkers.
Immunogenicity
Novel biological drugs have the potential to induce immune responses which can impact pharmacokinetics, efficacy, safety, and cross-react with endogenous molecules. Kymos Group immunogenicity services include:
- 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.
- Determination of Neutralizing Antibodies (NAb) to assess if the presence of ADAs inhibits the drug function:
- Cell-based assays (CBA).
- Binding assays using ELISA, ECLA or Surface Plasma Resonance (SPR) (Biacore®).
Why Choose KYMOS?
Services
Related services to Bioanalysis of Biologics & Biosimilars
Bioanalysis of Nucleic Acids
Quantification of nucleic acids as therapeutics, biomarkers or similar with standardized and reproducible methods according to GLP.
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