Bioanalysis of Nucleic Acids

GLP-certified bioanalysis of oligonucleotides with qPCR, Hybridization ELISA and LC-MS

Kymos Group 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, viral DNA and RNA, vaccines; offering specialized work for mRNA, microRNA, siRNA, ASO, aptamers and antagomiRs. We are proficient in method transfer and basic R&D for the development of nucleic acid bioanalytical methods from scratch.

KingFisher Prolytic
Oligo testing

Services

Bioanalysis of Nucleic Acids and Gene Therapy

PK and PD for Oligonucleotides, Transgene and Viral DNA/RNA

  • Preclinical and clinical studies, PK/PD quantification, calculations and statistics.
  • Real-Time qPCR, Hybridization ELISA and LC-MS/MS (Sciex 6500).
  • DNA, RNA, mRNA, microRNA, siRNA, aptamers and antagomiRs, Antisense Oligonucleotides (ASO), Bacterial and Viral DNA/RNA.

  • Preclinical and clinical studies
  • Reverse Transcription and Real-Time qPCR of mRNA
  • Singleplex and Multiplex assays

  • Biodistribution of oncolytic virus and bacteria, and viral vectors
  • Development and validation of analytical methods
  • Detection in different and complex matrices. More than 20 different tissues.
  • Real-Time qPCR.

  • miRNA, siRNA.
  • Gene expression of proteins and cytokines (efficacy)
  • Real-Time qPCR.

  • Immunogenicity against transgene and viral vector:
    • Binding anti-drug antibodies (ADAs) by ELISA/ECLA.
    • Neutralizing antibodies (NAb) by cell-based assays (CBA).

EXPERIENCE

Our Experience with Gene Therapy and Nucleic Acids:

Our success relies heavily on our experience with the following medicinal products and therapies:

  • Oncolytic Viruses

  • Viral Vectors: Adeno-Associated Virus
    (AAV), Herpesvirus

  • ASO (Antisense Oligonucleotides)

  • Transgene and Protein Encoding Gene Expression (mRNA, miRNA)

Team Discussion

Why Choose KYMOS?

  • Regulatory Excellence:

    FDA and EMA inspected. Development and GLP-Validation following in general the ICH M10 guideline (2023) adapted for qPCR use, according to the following guidelines:

    • Recommendations on qPCR/ddPCR assay validation by GCC (2022)
    • Requirements for evaluating the performance of quantification methods for nucleic acid target sequences (ISO 20395:2019)
    • FDA (2015). Design and analysis of shedding studies for virus or bacteria-based gene therapy and oncolytic products: guidance for industry
    • EMA (2018). Guideline on the quality, non-clinical and clinical aspects of gene therapy medicinal products.

  • Global Trust:

    • Partners of choice to several worldwide companies performing nucleic acid research or developing advanced therapies medicinal products (ATMP) and new drug modalities.

  • Extensive Expertise:

    • First-hand experience establishing robust and reliable methods for challenging nucleic acids including DNA, mRNA, microRNA, siRNA, ASO, aptamers and antagomiRs.
    • Combining our know-how on small and large molecules, we integrate our qPCR services with mass spec and immunology platforms in projects involving peptides or small molecules and their related biomarkers.

  • State-of-the-art equipment and techniques:

    • Equipped with cutting-edge RTqPCR for DNA/RNA quantification, Hybridization ELISA and LC-MS/MS for therapeutic oligonucleotides and nucleic acids.

Services

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Bioanalysis of Biologics and Biosimilars

Method development and validation and sample measurement of biologics and biosimilars.

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Pharmacokinetic Evaluation & Statistics

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

Small molecules

Bioanalysis of Small Molecules & Generics

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

Qtof Viral Vectors

Viral Vector Characterization

GMP-certified characterization and definition of quality attributes of Adeno-associated virus (AAV), Adenovirus (AV), and Lentivirus (LT).

Contact

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