Bioanalysis of Nucleic Acids

KYMOS has a dedicated team supporting GLP bioanalysis of nucleic acids in preclinical toxicokinetic, pharmacokinetic studies and clinical trials. We are a GLP-certified and GCP compliant multinational CRO with decades’ worth of experience working with large pharma companies, small biotech and gene therapy innovators. We are equipped with cutting-edge Real Time qPCR (RTqPCR), LC-MS/MS and Hybridization ELISA platforms for the analysis of DNA- and RNA-based biomarkers, therapeutic oligonucleotides, vaccines and specialty work with mRNA, microRNA, siRNA, aptamers and antagomiRs. We are proficient in method transfer and basic R&D for the development of nucleic acid bioanalytical methods from scratch. Our expert team can support you in the following areas:

Real Time qPCR for biomarker quantification
Hybridization ELISA and LC-MS/MS for therapeutic oligonucleotides quantification
PK (pharmacokinetics) and PD (pharmacodynamic) calculations and statistics

Real Time qPCR for GLP quantification of DNA/RNA biomarkers

• Absolute and relative ΔΔCt gene expression analysis in multiple biological matrices
• RTqPCR quantification of mRNA, siRNA, microRNA as well as aptamers and antagomiR therapeutics
• Bioanalytical investigations and biodistribution of DNA/RNA-based drugs
• Biodistribution of cell therapy products
• Quantification of residual human DNA and allografts decellularization efficiency
• Pathogen analyses by qPCR detection of viral and bacterial RNA/DNA in biological matrices
• Detection and quantification of host-related residual DNA or RNA in biopharmaceuticals
• Mycoplasma qPCR assays in in cell culture, media and biopharmaceuticals
• Ultra-sensitive qPCR detection up to 1pg/ml
• Automated magnetic bead isolation and purification of nucleic acids, proteins and cells

qPCR Oligo

Hybridization ELISA AND LC-MS/MS for GLP quantification of therapeutic oligonucleotides

  • Quantification of DNA/RNA-based substances and products for PK/TK characterization in formulation and biological matrices
  • Immunogenicity assays for the determination of Anti-Drug Antibodies (ADAs)
  • Real-time enzyme kinetics for specific and volume activity
  • ELISA-based detection in the range 0.5–1.000 ng/ml

PK and PD calculations and statistics

We have decades of experience providing pharmacokinetic, pharmacodynamic, toxicokinetic calculations and statistics with Phoenix WinNonlin® for bioanalytical data coming from preclinical and clinical studies. These services are offered individually or as a packaged clinical study and include:

  • Non-compartmental analysis (NCA)
  • Compartmental modelling using built-in models, self-generated ones and special considerations
  • Bioequivalence (AUC, Tmax, Cmax)
  • Evaluation of preclinical and clinical studies in human and animal health and consulting for designing new studies

PK/PD analysis is conducted using the gold standard Phoenix WinNonlin® software 8.2 to:

  • Analyze multiple matrices (plasma, serum, urine, blood etc..), dosing schedules and dosing routes using NCA
  • Perform compartmental modelling using built-in models or self-generated ones
  • Evaluate the bioequivalence of averages, individuals, or populations
Pharmakokinetic Evaluation

Why choose KYMOS to support your bioanalysis of nucleic acids

We are FDA and EMA inspected, GLP-certified and GCP compliant and the preferred partner to several worldwide companies. All our oligonucleotide assays were developed and GLP validated according to FDA, EMA, MHLW, MAFF and METI guidelines and regulations for veterinary and human medicinal products. Our team has first-hand experience establishing robust and reliable methods for the analysis of challenging nucleic acids including DNA, mRNA, siRNA and microRNA. Moreover, our complementary know-how in small and large molecules allows us to combine our qPCR services with mass spec and immunology platforms in projects involving peptides or small molecules and their related biomarkers.

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Related Services

Bioanalysis of Small Molecules

Development and validation of analytical methods for analysis of biological samples delivered mainly from pre-clinical and clinical studies.

Quality Control of Small Molecules

Analytical tests for APIs, excipients, intermediate products, finished products, packaging materials and process environment samples.

Batch Testing and Batch Release

KYMOS and PHARMAPROGRESS are GMP certified and we have a partial manufacturer authorization for Quality Control purposes.

Pharmacokinetics

Pharmacokinetic calculations and statistics of bioanalytical data from preclinical and clinical studies with Phoenix WinNonlin®.

Get in touch


    EU Sites

    Kymos Group

    Barcelona
    Spain

    Prolytic

    Frankfurt
    Germany

    Pharmaprogress

    Ancona
    Italy

    EU Offices

    Paris
    France

    Basel
    Switzerland

    Milano
    Italy