Bioanalysis

Bioanalytical CRO for cell and gene therapies

We specialize in PCR bioanalysis for the development of gene editing and nucleic acid-based therapies.

BIOANALYTICAL SERVICES

Quantification of viral and transgene RNA and DNA

We offer comprehensive bioanalysis services, including extracting, detecting, and quantifying 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

PK/PD analytes, including vector DNA, transgene DNA, or transgene RNA, are extracted and quantified 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.

Transgene expression​ TATAA Biocenter
Transgene expression

We quantify transgene RNA, derived from foreign genetic material, as a surrogate marker for protein expression and correlate it with bioanalysis for dosage optimization.

From sample to results

Expert in nucleic acid sample preparation and analyses

We specialize in quantifying RNA and DNA with low-copy numbers in diverse biological samples. Our expertise includes RNA/DNA extraction from complex tissues and biofluids, assay design for challenging targets (e.g. highly homologous sequences, short RNAs), and complex data analysis. We offer assay design, validation, and regulatory compliance tailored to your needs, whether for fit-for-purpose or full validation.

Extraction
The extraction is critical, capturing the target sequences unbiasedly and removing downstream inhibitors. We extract DNA and RNA of various lengths, ranging from miRNA and siRNA to entire genomes, using manual and automated workflows tailored to sponsor requests.
Sample types

We have experience in DNA and RNA extraction from diverse biofluids and tissues, excreta, LNPs, various sample tools, and biosafety level 1 and 2 agents. We can extract DNA and RNA from fresh, frozen, and fixed tissues and blood with multiple anticoagulants.

Nucleic acid biomarkers

We have extensive experience analyzing nucleic acid biomarkers like genetic SNPs, therapeutic RNA types such as siRNA and mRNA, and short RNAs like miRNA.

High quality data

Assay design is essential, knowing that what you measure mirrors reality. We control every step and adhere to technical standardizations such as the MIQE guidelines, regulatory requirements, and the latest scientific reports to provide the highest data reliability.

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.

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.

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.

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 capable of sequencing 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 us

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

PK/PD​ bioanalysis

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