EXPRESSION ASSAYS
mRNA quantification in diverse tissues
We offer PCR-based quantification of expressed RNA or administered mRNA for advanced therapies.
Transgene expression
Quantifying the transgene expression is crucial to assess tissue specificity and transduction efficiency and correlate with PK, shedding, efficacy, and potency for safety and dosing strategies.
Developers quantify transgene DNA introduced through gene-modified cells or in vivo administered vectors for PK, biodistribution, and shedding. The efficacy and pharmacodynamic assessments include quantifying the transgene product, the functional RNA, or protein. The functional therapeutic product is either an RNA molecule (microRNA, siRNA, etc.) or a functional protein transcribed from the transgene DNA with mRNA as a transient expression step. While the transgene protein is the most reliable indicator of translation, mRNA analysis offers greater sensitivity.
Monitoring transgene expression is crucial to confirm that it is restricted to the target tissue, indicating the specificity of the promoter. In addition, transgenic expression levels are essential to correlate with other upstream measurements, such as the number of vector copies (VCN) in the modified cell, pharmacokinetic and biodistribution profiles, and shedding to decide on dosing strategies.
RNA ASSAYS AT TATAA
TATAA Biocenter specializes in developing and validating quantitative nucleic acid analysis (qPCR and dPCR) for bioanalysis studies, including transgenic expression, while adhering to regulatory requirements for different phases. Our services encompass fit-for-purpose assays and fully validated assays.
We have extensive nucleic acid extraction experience from various specimens and decades of experience running qPCR and dPCR, detecting low abundant transgene RNA in complex matrices.
We perform high-throughput mRNA quantification using qPCR, dPCR, and NGS to identify the profile tissue expression, which is a surrogate marker for protein expression. The bioanalytical approach relies on highly sensitive PCR technologies to detect low-copy-number foreign mRNA in complex samples containing high endogenous DNA and RNA levels. The workflow involves tissue-specific optimized extraction of RNA. The extraction method’s quality directly impacts the PCR assay’s performance. We perform quantification using either qPCR or dPCR, which provides several advantages for detecting extremely low-copy-number RNA.
We use next-generation sequencing (NGS) techniques for transcriptomics to simultaneously measure all mRNAs or targeted mRNAs. This approach yields valuable insights into activated pathways down to the level of individual genes. Such data can serve various purposes, including assessing transgene expression, validating targets, evaluating target engagement, confirming the mechanism of action (MoA), providing early indications of off-target effects, and discovering new relevant biomarkers.
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About us
The power of our approach
Committed to quality, innovation, and fostering strong client relationships, we serve as your trusted partner to accelerate drug development. As a contract research organization, our mission is to push the boundaries of science and technology to generate accurate and reproducible data that shortens time-to-market.
Regulated laboratory environment
We are GLP accredited for qPCR, dPCR, and molecular biology, GCLP compliant, and ISO/IEC 17025 accredited. Our facility features a strict sample management process, a fully integrated LIMS system, backup for all vital systems, temperature and humidity control, and robust IT security.
Purpose-built PCR laboratory
Our purpose-built laboratory in Gothenburg, Sweden, is specifically designed for PCR. It has controlled air pressure, temporal separation, and biosafety cabinets to minimize contamination risk. This setup enables us to achieve the highest sensitivity and robustness required for validated assays. The lab is equipped with market-leading PCR and NGS instruments and advanced liquid handling systems.
Pioneers in assay development and validation
We are a team of 45 employees, with scientists at the forefront of assay development, optimization, and validation. Our team has co-authored key publications in the field, including Recommendations for Method Development and Validation of qPCR and dPCR Assays in Support of Cell and Gene Therapy Drug Development (AAPS J. 2024) and The MIQE Guidelines for qPCR and dPCR.
Flexible, client-centered solutions
We work closely with our clients to find tailored solutions, offering flexibility in sample types, test items, sample volume, and scalability. We prioritize transparency and proactive communication throughout each project, ensuring our clients are continuously updated on the progress.
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