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Overview

Save time developing and characterizing recombinant monoclonal antibodies (mAbs) from discovery through clinical trials and manufacturing by incorporating genetic-level analysis into your workflows. Leverage the sensitivity and dependability of Applied Biosystems QualTrak offering, a curated selection of real-time PCR (qPCR) workflows and digital PCR (dPCR) tools to identify and characterize antigens, develop and validate clones and cell lines, and detect even low levels of contamination to help ensure the safety and efficacy of your products.

QualTrak qPCR & dPCR digital experience

Discover a new way to navigate qPCR and dPCR applications throughout mAb development—from discovery through cGMP manufacturing.

QuantStudio 7 Pro Real-Time PCR System

Learn about an automatable qPCR instrument with functionality to support regulatory requirements and generate reliable data.

QualTrak Biopharma ecosystem

Learn how the curated QualTrak offering of qPCR and dPCR instruments, reagents, and assays can help streamline biologics development.


QualTrak workflows for mAb development

Real-time PCR and digital PCR have use-cases accoss monocolonal antibody development pipelines. Explore suggested workflows, products, and support options in the QualTrak digital experience.

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Discovery

Antigen identification and functional characterization

Gene expression

Genotyping

Antibody screening and selection

Antibody gene ID

Biomarker ID

Process development

Cell line development

Genetic integration

Cell/clone selection

Cell banking (MCB/WCB)

Cell stability & efficiency

Adventitious agent testing

In-process test development

Impurity & contamination testing

Viral clearance

Sterility testing

Bioburden

Residual host-cell DNA

Pre-clinical and clinical trials

Biodistribution

PK/PD studies

Toxicity/safety

Efficacy

Patient screening/ID

Viral testing

cGMP manufacturing

In-process testing + lot release

Impurity & contamination testing

Viral clearance

Sterility testing

Bioburden

Residual host-cell DNA


QualTrak resources for mAb development

Find out how partnering with Thermo Fisher Scientific can connect you to the qPCR and dPCR tools and solutions you need to streamline your pipeline—from discovery through cGMP manufacturing.

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