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9-Part Series

Scaling Success: How Innovation and Automation are Revolutionizing Cell Line Development

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Infographic

CLD for Next Gen Biologics—Your 2-Minute Brief

A one-page, shareable roadmap to move complex candidates faster with records you can defend

Written byDanaher andLab Manager

Complex antibody modalities are stretching old CLD playbooks. This one-page infographic distills four high-return steps to modernize screening, analytics, and data practices so you can make faster, defensible decisions. Skim in two minutes, share with the team, and align stakeholders quickly.

Download the infographic for actionable next steps and snapshots you can bring to QA/leadership with emphasis on:

Speed to value: where to compress time from screening to CQAs
Faster first mile: reduce screening and selection delays
Consistent comparisons: evaluate candidates with fit-for-purpose analytics
Audit-ready traceability: capture context at execution with a connected data backbone

Want the deeper dive? Read the companion eBook.

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Top Image Credit:

Danaher

Innovations that Accelerate

Cell Line Development

Cell line development (CLD) is a pivotal stage in recombinant protein-based therapeutic drug development. Antibodies are a rapidly evolving modality,

with advancements in bi- and trispecific antibodies, antibody-drug conjugates and fragments such as Fabs. This new variety adds complexities to

traditional CLD workflows. However, CLD labs have access to robust, innovative solutions that address pain points and boost efficacy and efficiency.

From faster identification of promising cell lines to improved regulatory reporting, learn how these innovations may lead to improved data-driven

decision-making, regulatory compliance and accelerate time to market for life-saving therapies.

Streamline Selection Boost Automation Ensure Compliance

Problem Solution

Limiting dilution is labor-intensive.

• Excessive manual labor and time

• Hit or miss on single cell deposition

• Lower confidence of clonality

High-performance liquid chromatography

(HPLC) is a lengthy and work-intensive

process to quantify titer.

• Lengthy sample prep

• Limited throughput and high complexity

Scientists may spend 30-40 percent

of the day on manual data handling,

introducing challenges at every stage

of drug development.

• Slows productivity

• Error-prone

• Poor data hand-off

• Delays reporting

• Reduced data integrity

Characterization of individual charge variant

components using standard capillary

isoelectric focusing (cIEF)

or ion exchange chromatography (IEX) with

fraction collection can take weeks.

• Separate MS and imaging analysis

workflows

• Reduced data integrity

• Manual workflow steps

• Multiple instruments

• Limited throughput

A fully automated clone screening and

colony picking solution.

• 10x faster performance than limiting

dilution with significantly less hands-on

time compared to FACS & limiting dilution

• Screen >10,000 clones per day

• Image-based monoclonality assurance

• Full data tracking and analysis

Screening for high-value clones can be

accelerated with a fast, robust immunoglobulin

G (IgG) quantification assay.

• Simple: Add, mix & read

• Rapid: Results in less than 15 minutes

• Accurate: >95%

• Automation-friendly and high throughput

(96- or 384-well assays)

A biopharmaceutical lifecycle management

software platform that extends throughout

the drug development pipeline, including

CLD, to improve data workflows and

compliance.

• Accelerates timelines

• Increases insights

• Improves knowledge transfer

• Facilitates FDA and EMA compliance

Automate protein characterization with

integrated imaged capillary isoelectric

focusing and mass spectrometry (icIEF-UV/

MS) technology for rapid, robust

CQA verification.

• Monitor multiple attributes on a single

integrated platform

• Separate, quantify and identify charge

variants in minutes

• Comprehensive protein therapeutic

characterization with high sensitivity and

selectivity

• High-resolution, high-quality data

By implementing several innovations, we can significantly accelerate the antibody CLD process in drug development. These innovations are made possible by the Life Sciences companies of Danaher. We have a proud record of

partnering with scientists, applying our scientific and operational expertise to help them pioneer more effective treatments and develop more efficient workflows. The Life Sciences companies of Danaher are committed to driving

industry advancements, empowering labs with tailored solutions to revolutionize their CLD workflow and create life-changing medicines through scientific innovation.

For research use only. Not for use in diagnostic procedures.

© 2024 DH Life Sciences LLC. © 2024 Abcam Limited. Valita and Valita Titer are trademarks or registered trademarks of ValitaCell in the United States and other countries. ValitaCell is a Beckman Coulter Company. © 2024 Beckman Coulter, Inc. Beckman Coulter, the stylized logo, and the Beckman Coulter product and service marks mentioned herein, including Biomek, are

trademarks or registered trademarks of Beckman Coulter, Inc. in the United States and other countries. All other trademarks are the property of their respective owners. © 2024 Genedata AG. © 2024 ID Business Solutions, Ltd. © 2024 Molecular Devices, LLC. The trademarks used herein are the property of Molecular Devices, LLC or their respective owners. Specifications are

subject to change without notice. © 2024 Phenomenex, Inc. © 2024 DH Tech. Dev. Pte. Ltd. Trademarks and/or registered trademarks mentioned herein, including associated logos, are the property of AB Sciex Pte. Ltd. or their respective owners in the United States and/or certain other countries. Intabio is being used under license. All rights reserved.

Learn more about how to accelerate your cell line development process with the Life Sciences companies of Danaher at DHRLS.co

1 Automated clone screening

Monoclonal verification on day zero.

2 Titer screening

Find high-value clones faster.

3 Full drug discovery pipeline

Accelerate data capture, analysis

and reporting.

4 Identify and monitor critical

quality attributes (CQAs)

Fast-track mAb characterization

and quantitation.