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.

compliant bioanalysis

Accurate and reproducible data

A GLP accredited and GCLP compliant laboratory

TATAA Biocenter is accredited by the Swedish Board of Accreditation and Conformity Assessment (SWEDAC) for complying with Good Laboratory Practice (GLP) standards. We also adhere to Good Clinical Laboratory Practice (GCLP) guidelines, which are international quality standards governing the analysis of samples from clinical trials using GLP.

GLP and GCLP validation is mandatory in preclinical and clinical assays to demonstrate accuracy, reliability, and consistency. These standards cover every aspect of study planning, execution, monitoring, documentation, archiving, and reporting. This rigorous process assures both the sponsors, when submitting data for new drug approvals, and the regulatory authorities, when reviewing the data, that it is generated in a regulated manner.

drug development TATAA Biocenter
Lines in Circle Mask - Lg
method validation

Accelerate drug development with validated assays

Validated bioanalysis is essential throughout the entire drug development process.

Conducting fit-for-purpose validations in the initial stages of discovery is key. These validations offer valuable insights of expected assay performance before undertaking more comprehensive method validation processes. A validated PCR assay is essential to ensure the accuracy and reliability of results and ensures that the assay meets the client’s needs, study requirements, and assay criteria under defined operating conditions. Our assay validations ensure dependable data for making stage-gate decisions and preparing regulatory filings.

A validated assay is a valuable asset.

BIOANALYTICAL SERVICES

Quantification of viral and transgene RNA and DNA

We offer comprehensive bioanalytical services, including the extraction, detection, and quantification of viral and transgene RNA and DNA analytes from diverse tissues and biofluids. We design and conduct assays, ensuring that the validation aligns with your regulatory requirements, whether for fit-for-purpose or full validation.

PK/PD​ TATAA Biocenter
PK/PD

We extract and quantify PK/PD analytes, including vector DNA, transgene DNA, transgene RNA, and expressed RNA, using validated PCR methods to determine the PK and PD profiles.

Biodistribution

We monitor the biodistribution of genetically modified cells, viral vectors, and mRNA vaccines within the body using validated PCR methods.

Shedding TATAA Biocenter
Shedding

We quantify shed viruses, bacteria-based gene therapy products, or oncolytic products in sweat, urine, excreta, and various body fluids

The Olink Target 96 panels are designed for high throughput, cost efficiency, and low sample consumption, facilitating targeted biomarker research in various disease areas and biological processes. The Olink Target 96 panels simultaneously enable high-multiplex targeting analysis of 92 protein

The Olink Explore 384 panels collectively form the comprehensive Explore 3072 panel. Run one or several of these panels on each sample simultaneously. Each Olinke 384 panel contains carefully selected proteins validated for human plasma and serum samples, making it

The Explore HT panel contains over 5,400+ proteins, almost twice as many as the Explore 3072 panels. The sample volume for Explore HT is 2 µl, compared to 6 µl for Explore 3072. The workflow for Explore HT is four

why work with tataa?

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, we are committed to generating accurate and reproducible data that shortens time-to-market.

Experienced scientists

We are ahead of industry trends and always updated on the regulatory landscape and requirements for gene editing and nucleic acid-based therapies. Our purpose is to provide data that’s easily auditable.

Total project transparency

We maintain transparency and proactively communicate throughout the project, ensuring our clients always stay updated on the progress. Transparency forms the cornerstone of our proven client model.

Have confidence in your data

We use the highest quality reagents, adhere to dedicated controls, and standardize all processes per technical requirements like the MIQE guidelines. We deliver rapid, robust, and reproducible results that are submission ready.

Flexible and scalable

Every project is customized to meet our client’s specific needs. We manage projects of all sizes and all stages, including any or all phases from sample extraction to analysis and data transfer. Your goals are our deliverables.

TECHNOLOGIES

We operate with the latest technologies

TATAA Biocenter comprises highly skilled scientists with extensive expertise in method development, optimization, validation, and optimization of molecular analysis. We leverage market-leading instrumentation and automation platforms, offering expert guidance to choose the most suitable technology for your program.

PCR Analysis TATAA Biocenter
PCR

We use highly sensitive and highly precise quantitative PCR (qPCR) and digital PCR (dPCR) technologies to detect one or multiple DNA/RNA targets in complex samples.

NGS Services TATAA Biocenter
NGS

We use NGS, a powerful tool to sequence entire exomes, genomes, or transcriptomes, and our scientists and bioinformaticians provide comprehensive sequencing data.

Olink service provider TATAA Biocenter
Quantitative proteomics

We are a designated Olink service provider with the latest technologies for running quantitative proteomics using Olink’s panels for biomarker discovery, validation, and screening.

contact

Let's explore how we can support your drug development program

PK/PD​ bioanalysis

General Transgene expression Page

"*" indicates required fields