Droplet Digital PCR

Quality Control Solutions for Cell and Gene TherapyYour Partner from Discovery to Therapeutic

Visit bio-rad.com/ddPCRAppsGuide for more information.

Unrivaled Precision and Accuracy
for Cell and Gene Therapy
INSTRUMENTSSERVICESOFTWARE

CELL AND
GENE THERAPYAPPLICATIONSASSAYS

KITS

Droplet Digital PCR (ddPCR) provides highly precise and absolute quantification of nucleic acids by counting
nucleic acid molecules encapsulated in discrete water-in-oil droplets. Digital measurement of nucleic acids
using Droplet Digital PCR is suitable for the analysis of both in-process samples and final drug products due tothe technology’s tolerance to PCR inhibitors. This tolerance to formulation matrices enables the implementationof Droplet Digital PCR throughout the entire manufacturing process. Bio-Rad ddPCR Systems utilize a simple
workflow with minimal hands-on time while reducing sample replicates and user-to-user variability.

2 | BIO-RAD LABORATORIES, INC.

ddPCR Assays and Kits
for Cell and Gene Therapy
Bio-Rad offers a comprehensive portfolio of ddPCR Assays and Kits for numerous applications, including
mutation detection, copy number determination, genome edit detection, gene expression analysis,
Mycoplasma detection, multiplex mutation screening, residual DNA quantification, and library quantification.
Absolute quantification means Droplet Digital PCR can confidently discriminate
between consecutive vector copy numbers; qPCR cannot.
Droplet Digital PCR
is more tolerant to
PCR inhibitors thanquantitative PCR (qPCR),
making it ideal for
detecting rare targets
in the complex sample
matrices used forresidual DNA detection.

Multiplex Mutation
Screening
Copy Number
Determination
Residual DNA
Quantification

Mutation
Detection

ddPCRKits

Copy Number
DeterminationCAGTGTCA

Self-complementary adeno-associatedvirus (AAV) genomes can inadvertently
block primer/probe binding sites throughself-annealing, complicating viral titeranalysis by qPCR. ddPCR Expert
Design Assays provide a more robust
measure of viral titer without the need fora standard curve.

Expert DesignddPCR
Assays

Library
Quantification
Genome Edit
Detection

Mycoplasma
Detection
Unlike qPCR, Droplet Digital PCR enables
the ratio of genome copies to colony forming
units to be calculated during Mycoplasma
testing without a standard curve.

ATGC

CustomGene Expression

Cell andGene Therapy

Find and Buy Your ddPCR Assay
Take advantage of 24/7 service to find, design,and buy an assay in three steps:1 	
Choose your application or search byAssays targeting the therapeuticgene of interest are crucial to quality
control in cell and gene therapy.
ddPCR Cell and Gene Therapy
Assays offer robust assay design andsequences for gene of interest titer andcopy number measurements.

Assay Design Service
Click the icon to obtainassistance with assay
design from our ddPCR
specialists.

unique assay ID

Browse Digital Assays

3 | BIO-RAD LABORATORIES, INC.

2Enter target or sequence information

Interactive Infographic

3

Pick a size and add to your cart

Click the icon to findddPCR Assays and Kits
for your cell and genetherapy application.

Gene Therapy

Developing effective and reproducible gene therapies requires the use of sensitive and robust testing methods,
such as Droplet Digital PCR, to validate the quality of the therapeutic product. Bio-Rad offers a portfolioof ddPCR viral quantification solutions for the accurate, precise, and robust measurement of viral titer in asample. Scientists may also use some of these solutions to perform quality checks on incoming plasmids andto conduct gene therapy biodistribution studies.
In-Process Testing
Virus Production
and Recovery

Transfection

Plasmid Quality■

Perform plasmid
quality checks
using Expert
Design Assays

Create Custom
ddPCR Assays
for plasmid qualitychecks using theCell and Gene
Therapy DesignEngine

Virus Purification

Potency

Viral Titer

■

■

■

Final Quality Assurance (QA)/Quality Control (QC)■ everage Expert Design Assays to get robust viralLtiter measurements

 reate Custom ddPCR Assays for viral titer measurementC
using the Cell and Gene Therapy Design Engine

Learn more about our complete ddPCR workflow
solution for AAV vector genome titer

4 | BIO-RAD LABORATORIES, INC.

■

Patient Monitoring

PuritySafetyVerify Therapeutic
Delivery andExpression

Residual DNA

Mycoplasma

Gene Expression■
Achieve absolute
quantification ofresidual host DNA
using ddPCR
Residual DNA
Quantification Kits.
The sensitivity ofDroplet Digital PCR
ensures adherence
to the U.S. Food andDrug Administration(FDA) guideline of■<100 pg host DNAper doseReduce false
positives with theVericheck ddPCR
MycoplasmaDetection Kit earn how toL
transition toDroplet Digital PCR
from qPCR for
Mycoplasma testing■■Evaluate thebiodistribution
and transgene
production level ofyour cell therapy
using our Expert
Design Assays

Design custom
ddPCR Assays foryour gene of interest
using our Assay
Design Engine

Cell Therapy

Development, validation, and implementation of robust and accurate methods are vital to test the safety andefficacy of gene-modified cell therapies such as chimeric antigen receptor (CAR) T cells. Droplet Digital PCR
offers absolute quantification of transgene copy number in a sample. This method can be used to effectively
quantify CAR copy numbers in transfected or transduced T cells or count the number of cells that contain thetransgene of interest. This is especially important for transgenes that cannot be detected by antibodies. TheddPCR whole-cell DNA workflow is a reproducible and easy way to measure the percentage of edited cellswith minimal input cells and can be applied at multiple steps during the cell therapy manufacturing process.
In-Process Testing
Activate andTransduce T Cells

Incoming Vector

Plasmid Quality■■

Perform plasmid
quality checksusing Expert DesignAssays

Final QA/QC
Prepare Final
Cell Dose

TransgeneExpression■

Verify transgene
expression foranti-CD19 CAR-Tcells using theCAR-T CD19
Monitoring AssayCreate Custom
ddPCR Assays
for plasmid quality
checks using theCell and Gene
Therapy DesignEngine

Vector Copy Number■■■ uantify genetic modifications in whole cells ■Qusing whole-cell Droplet Digital PCR. This
protocol allows cell counting by encapsulating
whole cells and targeting the transgene andreference gene to amplify the DNA within earn how Fehse et al. (2020) developedLa ddPCR Assay for precise quantificationof anti-CD19 CAR-T cells down to 0.01%
frequency from patients treated withaxicabtagene ciloleucel (axi-cel) lick to watch the webinar: In-vivoCmonitoring of CAR-T cells using
sensitive Droplet Digital PCR

WEBINAR5 | BIO-RAD LABORATORIES, INC.

Potency

Patient Monitoring

PuritySafetyVerify Therapeutic
Delivery andExpression

Residual DNA

Mycoplasma

Gene Expression

Achieve absolute
quantification ofresidual host DNA
using ddPCR
Residual DNA
Quantification Kits.
The sensitivity ofDroplet Digital PCR
ensures adherence
to the U.S. FDA
guideline of <100 pg
host DNA per dose■■Reduce false
positives with theVericheck ddPCR
Mycoplasma
Detection Kit earn how toL
transition toDroplet Digital PCR
from qPCR for
Mycoplasma testing■■

Verify gene
expression foranti-CD19 CAR-T
cells using theCAR-T CD19
Monitoring Assay lick to read theCpaper: Insights
on Droplet Digital
PCR–BasedCellular Kinetics
and Biodistribution
Assay Support for
CAR-T Cell Therapy

ddPCR Software
Bio-Rad ddPCR Systems and Software meet the needs of GMP manufacturing and QC environments,
complying with the FDA’s Title 21 Code of Federal Regulations Part 11 for electronic documentation andsignatures. QX Software is a family of powerful software packages for acquiring and analyzing your ddPCRdata. When connected to a ddPCR System, QX Software provides all the necessary functionality to create,
run, and analyze experiments.
With QX Software, you can:
■

■

■

■

Plate 2D Amplitude Chart

Analyze
your data files in a variety of charts and tables in theanalysis module reate customized templates for both reports and platesCenabling simple standardization of reporting and data acquisition
View system and experiment audit logs
 roduce an audit log report on old and new data values afterP
reprocessing a file

Bio-Rad voluntarily complies with Internal Organization forStandardization (ISO) 13485. This standard has additional
requirements beyond ISO 9001, including product-specificdemands and more stringent documentation requirements.
Visit bio-rad.com/QXSoftware to learn more.

QX Software allows you to visualize any combination ofchannels in 2-D plots, side-by-side on the screen or ina 96-well plate layout.
3D Amplitude Chart

After selecting a well in the toolbar, the 3-D amplitude display
illustrates three targets that you can select in a single chart.

6 | BIO-RAD LABORATORIES, INC.

ddPCR Application 11
Support and Services
Bio-Rad has the experience and dedicated tools to support the development, analysis, and manufacturingof your cutting-edge cell and gene therapies.
Droplet Digital™ PCR

Applications Support
Our dedicated field applications scientists leverage an unparalleledbreadth of skills to:■■

Droplet Digital PCR Applications Guide
Read in-depth information about settingup experiments for ddPCR applications.

 rovide training and assistance with data analysis,
Ptroubleshooting, and optimization
 ssist customers with experimental design, assay design,Aand reporting of results

ServiceWith more than 50 years of dependable and experienced service
and support to the scientific community, we are here when you
need us.

Visit bio-rad.com/ddPCRAppsGuide for more information.
Droplet Digital™ PCR
Applications Guide

BIO-RAD, DDPCR, and DROPLET DIGITAL PCR are trademarks of Bio-Rad Laboratories, Inc.
in certain jurisdictions. All trademarks used herein are the property of their respective owner.

Services include:■ Installation qualification (IQ)
■ Operational qualification (OQ)■ Preventative maintenance and operational qualification (PM/OQ)■ Thermal validation
Our service contract plans ensure coverage for routine maintenanceand emergency repairs at no additional cost. Plans include:■

Service and repair coverage■

Replacement parts, travel, and labor■

Prioritized response time

■

■

■

 reventative maintenance for critical componentsP
in regulatory environments
Equipment qualification
 alidation services environments, equipment qualification,Vand validation services

Bio-RadLaboratories, Inc.
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