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 nucleic acids, 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:

• 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

• 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

We have decades of experience providing pharmacokinetic, pharmacodynamic, toxicokinetic calculations and statistics with Phoenix WinNonlin® for bioanalytical data coming from preclinical and clinical studies. Please find more information on our service page Pharmacokinetic Evaluation & Statistics

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.