Real-Time PCR Solutions for Monoclonal Antibody Development

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 biopharma-specific real-time PCR (qPCR) workflows 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 mAb workflow

The QualTrak mAB workflow includes qPCR use cases across all steps of the development pipeline from discovery to GMP manufacturing.

QuantStudio 7 Pro Real-Time PCR System

Ensure you generate data you can trust, backed by our robust support capabilities, including compliance and audit services. 

Scientists in sterile dress walking though laboratory

Compliance documentation

QualTrak cGMP-compliant assays and reagents include quick and easy access to documentation.

Scientists in clean suits using digital tablets in laboratory

QualTrak workflow

Use cases for real-time PCR solutions across monoclonal antibody development workflow

Discovery

Antigen identification and functional characterization

Gene expression

Genotyping

Antibody screening and selection

Antibody screening

Antibody gene ID

Biomarker ID

Process development

Cell line development and clone selection

Genetic integration

Cell/clone selection

Cell banking (MCB/WCB)

Cell stability & efficiency

Adventitious agent testing

In-process test development/optimization

Impurity/contamination

Viral clearance

Sterility testing

Bioburden

Host cell DNA

Pre-clinical and clinical trials

Biodistribution

PK/PD studies

Toxicity/safety

Efficacy

Patient screening/ID

Viral testing

Histology and pathology test

cGMP manufacturing

In-process testing + lot telease

Impurity/contamination

Viral clearance

Sterility testing

Bioburden

Host cell DNA

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