Bioanalysis of
Nucleic Acids
GLP-certified bioanalysis of oligonucleotides with qPCR, Hybridization ELISA and LC-MS in preclinical toxicokinetic, pharmacokinetic studies and clinical trials.
Expertise in Gene Therapy & Nucleic Acids
BrownBiology Laboratory 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 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.
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Our Services
Comprehensive bioanalytical coverage across distinct nucleic acid workflows.
PK & PD for Oligonucleotides, Transgene & 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.
Gene Expression
- Preclinical and clinical studies
- Reverse Transcription and Real-Time qPCR of mRNA
- Singleplex and Multiplex assays
Biodistribution and Shedding Studies
- Biodistribution of oncolytic virus, bacteria, and viral vectors
- Development and validation of analytical methods
- Detection in different and complex matrices (more than 20 different tissues)
- Real-Time qPCR
Genetic Biomarkers
- miRNA, siRNA
- Gene expression of proteins and cytokines (efficacy)
- Real-Time qPCR
Immunogenicity
- Immunogenicity against transgene and viral vector
- Binding anti-drug antibodies (ADAs) by ELISA/ECLA
- Neutralizing antibodies (NAb) by cell-based assays (CBA)
Demonstrated Experience
Our success relies heavily on our experience with the following medicinal products and therapies:
- 鈥?/span>Oncolytic Viruses
- 鈥?/span>Viral Vectors: Adeno-Associated Virus(AAV), Herpesvirus
- 鈥?/span>ASO (Antisense Oligonucleotides)
- 鈥?/span>Transgene and Protein Encoding Gene Expression (mRNA, miRNA)
Why Choose BrownBiology?
Regulatory Excellence
FDA and EMA inspected. GLP-Validation following ICH M10 guideline (2023) adapted for qPCR use, GCC recommendations, ISO 20395:2019, and FDA/EMA gene therapy guidelines.
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 methods for DNA, mRNA, microRNA, siRNA, ASO, aptamers. We integrate qPCR with mass spec and immunology platforms.
State-of-the-Art Equipments
Equipped with cutting-edge RTqPCR for DNA/RNA quantification, Hybridization ELISA and LC-MS/MS for therapeutic oligonucleotides and nucleic acids.
Accelerate Your Nucleic Acid Program
Let our experts design the optimal bioanalytical strategy for your advanced therapy or gene therapy product.