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PCR assay validation guide for regulated bioanalysis — qPCR and dPCR method development, qualification and validation at TATAA Biocenter

Development, Qualification, or Validation?

Understanding the qPCR/dPCR assay lifecycle in regulated bioanalysis Validation is a critical part of generating reliable bioanalytica...

Chain of custody in regulated bioanalysis at TATAA Biocenter

Chain of Custody in Regulated Bioanalysis: Protecting Every Sample, Every Record, Every Result

In regulated bioanalysis, chain of custody connects sample identity, data integrity, and audit trails from receipt to result. See why it matters for GLP/GCLP-compliant cell and gene therapy, biomarker, and molecular bioanalysis programs at TATAA Biocenter.

GLP and GCLP molecular bioanalysis validation workflow at TATAA Biocenter — from method development to archiving and traceability

GLP & GCLP Molecular Bioanalysis: Validating qPCR, dPCR and RNA-Seq for Preclinical and Clinical Studies

If you are choosing where to send your regulated molecular bioanalysis, the real question is not whether a laboratory can run a qPCR or...

Two-Tailed RT-qPCR hairpin primer binding siRNA target for GLP-grade quantification at TATAA Biocenter

Two-Tailed PCR: The Precision Tool RNA Medicine Has Been Waiting For

Why Short RNA Quantification Has Never Mattered More The RNA therapeutics revolution is accelerating. The list of FDA-approved siRNA d...

Abstract visualisation representing inter-batch variability data analysis in the Olink Target 48 Cytokine panel

Keeping longitudinal clinical trials on track: How we approached inter-batch variability in the Olink Target 48 Cytokine panel

Multi-year clinical trials place extraordinary demands on bioanalytical laboratories. When the same patient samples are measured repeat...

Diagram of T cell receptor (TCR) complex showing alpha, beta, gamma and delta chains across the extracellular and intracellular membrane

TCR Sequencing: Decoding the Immune Response Across Vaccines, Cancer Immunotherapy, and Disease

Every T cell in your body carries a unique molecular fingerprint: the T-cell receptor (TCR). This receptor determines which antigens a ...

Monitoring CAR-T safety: TCR and BCR sequencing help detect clonal expansions and assess long-term malignancy risk.

CAR-T safety monitoring

Integrating viral vector-based cell and gene therapies carry a potential risk of secondary cancers, prompting the FDA to require 15 years of post-marketing follow-up for CAR-T therapies.

Application

PAXgene RNA extraction

TATAA Biocenter’s optimized protocol enables high-quality RNA extraction from PAXgene® blood RNA tubes, delivering improved RNA integrity and yield for both clinical and preclinical applications.

Application

Overview of qPCR, dPCR, and Two-Tailed PCR technologies for gene expression, biomarker analysis, and regulated bioanalysis in drug development.

Guide to PCR in drug development

A comprehensive guide to qPCR, dPCR, and Two-Tailed PCR for regulated and exploratory applications in drug development.

Guide

Vector copy number (VCN) quantification in CAR-T cells using qPCR and dPCR to support safe dosing, persistence monitoring, and regulatory compliance.

Vector copy number analysis in CAR-T development

Precise VCN quantification in CAR-T therapy, enabling safe dosing, persistence monitoring, and regulatory compliance.

Application

Sensitive siRNA bioanalysis using qPCR, dPCR, NGS, and Two-Tailed PCR to assess stability, distribution, and gene-silencing efficacy.

siRNA bioanalysis with qPCR, dPCR, and NGS

Sensitive and precise siRNA bioanalysis with qPCR, dPCR, NGS, and Two-Tailed PCR technology.

Application

GLP-1 receptor agonists therapeutics

Mechanisms, therapeutic applications, and future directions in precision medicine for GLP-1 receptor agonists.

Overview

Overview of bioanalysis in advanced therapies

Assay design and validation
Regulatory guidelines (EMA and FDA)
Challenges and best practices

Guide

Unlocking insights with genomic biomarkers: Supporting precision medicine through targeted analysis of gene variants, expression patterns, and treatment response.

Genomic biomarker analysis (DNA, RNA, miRNA, ctDNA etc,)

Technology overview
Analytical validation
Regulatory overview

Guide

Explore TATAA’s capabilities: A comprehensive overview of our molecular CRO services supporting drug development from discovery to regulated bioanalysis.

TATAA capabilities brochure

Download our latest brochure for an overview of our molecular CRO expertise in CGT bioanalysis, biomarker analysis, and assay development.

Brochure

Advancing Vaccine Research with Illumina Protein Prep

Discover our recent application note on advancing vaccine research with one of the most comprehensive protein profiling panels available.

Application