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

Precision and Accuracy in qPCR and dPCR Assay Validation

Part 2 of the PCR Assay Validation Guide In Part 1 of this guide, we discussed how assay validation begins with defining the context of...

Immune cells illustrating the complexity of the immune response monitored in vaccine development studies

Immune Monitoring for Vaccine Development Using Illumina SomaSeq Discovery

A novel high-throughput platform for sensitive and scalable immune profiling using the widest protein assay available. Unbiased ...

Development, Qualification, or Validation?

Part 1 of the PCR Assay Validation Guide — Understanding the qPCR/dPCR Assay Lifecycle Validation is a critical part of generating reli...

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 ...

Scientist working with advanced technologies such as qPCR, dPCR, and next-generation sequencing to identify reliable biomarkers and support translational research.

Genomic biomarkers

Introducing genomic biomarker analysis A biomarker is an objectively measurable factor that can indicate disease risk, predict treat...

Illustration of a medical syringe representing siRNA-based advanced therapies for targeted gene silencing.

qPCR, dPCR, and NGS for siRNA bioanalysis

Quantitative PCR (qPCR), digital PCR (dPCR), and Next-Generation Sequencing (NGS) are essential technologies in siRNA bioanalysis. They...

Sterile vials prepared for use in advanced therapy development and bioanalysis.

Precision bioanalysis for advanced therapies

Method development and validation of regulatory qPCR and dPCR assays for biodistribution, viral shedding, and pharmacokinetics in gene ...

Comprehensive_Safety_Testing_in_CAR-T_Using_TCR-BCR_Sequencing_Olink_and qPCR-dPCR Illustration of CAR-T safety testing combining TCR/BCR sequencing, Olink proteomics, and qPCR/dPCR for comprehensive monitoring.

TCR/BCR sequencing and dPCR for CAR-T safety monitoring

Immunosequencing entails the high-throughput sequencing of T-cell (TCR) and B-cell receptors (BCR), offering invaluable insights into t...

Illustration of blood sample collection for RNA extraction using PAXgene tubes.

RNA extraction from PAXgene tubes

Controlling and optimizing steps in extracting RNA from PAXgene tubes significantly improves yield and quality and can lead to more acc...

Scientist analyzing digital PCR results for replication competent lentivirus detection in a high-throughput lab environment

Replication competent lentivirus testing

Ensuring biosafety in cell therapies: Replication Competent Lentivirus Testing (RCL) with digital PCR Why Replication Competent Lentiv...

Oligonucleotide therapeutics targeting a long non-coding RNA (IncRNA). Antisense oligonucleotide (ASO) or small interfering RNA (siRNA) binds to a lncRNA strand, leading to its degradation or functional inhibition.

IncRNA: From junk to a therapeutic goldmine

Not long ago, much of the genome that doesn’t encode proteins was dismissed as junk DNA. But science has made it abundantly clear that ...

Viral vector characterization and vector integrity assessment using molecular techniques for gene therapy quality control.

Viral Vector Characterization and Integrity Testing

Viral vector characterization is the comprehensive analytical process used to evaluate the quality, identity, purity, potency, and safe...

Vector copy number (VCN) analysis using qPCR and dPCR for cell and gene therapy applications.

Vector Copy Number Analysis

Balancing efficacy and safety through VCN analysis Vector copy number is all about balancing efficacy against safety. More copies will...

qPCR Primer Design

This guide discusses strategies for designing qPCR assays, including primers and probes, for bioanalysis in cell and gene therapies.qPC...

Quantitative PCR analysis of residual host cell DNA in biologics for safety and regulatory compliance.

Host Cell DNA Residual Detection

Biotherapeutics produced in host cells must undergo monitoring for residual host cell DNA during manufacturing and in the final product...

qPCR assay using Two-Tailed PCR technology as an alternative to stem-loop primers for short RNA analysis.

Stem-Loop vs. Two-Tailed Primers

Stem-loop primers or Two-Tailed primers are required to amplify small RNAs, such as siRNA, miRNA, snoRNA, and others, ranging from appr...

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