We see a way to
access multidimensional data in minutes instead of weeks.
identify high producers in less than 15 minutes in cell line development.
save over 14,000 hours of manual data handling time per year in a cell line development department
We see a way to
save
over 14,000
hours of
manual data handling time per year
in a cell line development department.
The Life Sciences Companies of Danaher support biopharma and service providers in their endeavor to accelerate the CLD process with its comprehensive platform of best-in-class science and technology companies. We recognize the necessity for solutions that eliminate bottlenecks faster and aim to address this with our extensive instrument, software, and services portfolio.
IDBS Polar Biopharma Lifecycle Management Software
Digital solutions for bioprocessing that help manage complex datasets
SCIEX Intabio ZT System
Disruptive approach for characterization of mAb charge variants by imaged capillary isoelectric focusing (icIEF)-UV/MS
Beckman Coulter Life Sciences Valita Titer Rapid high-throughput IgG quantification assay
Assays that bring complex analytical methods into CLD lab and cut time to data
Cell Line Development Process
One lab, three paths to faster outcomes
LABORATORY AUTOMATION | DIGITAL SOLUTIONS
01 - Vector Construction
The vector construction step of monoclonal antibody (mAb) cell line development requires identifying a gene sequence and assembling it for packaging into a recombinant plasmid. Golden Gate and Gibson assembly are methods of generating recombinant plasmids by ligating small oligos together. The Life Sciences Companies of Danaher provide solutions to support your recombinant plasmid construction.
- Design sequences and assemble vectors for mAb expression using IDT Synthetic Oligonucleotides and Beckman Coulter Life Sciences Echo Acoustic Liquid Handler for oligo arrays and reagents for plasmid creation.
- Confidently screen the created diversity of candidates and select the best hits. Leverage the Molecular Devices QPix 400-Series Microbial Colony Picker for automated selection and growth of putative plasmid-containing bacterial clones.
- Use the Beckman Coulter Life Sciences Biomek i-Series Automated Workstation to prepare samples and distribute screening reagents.
DIGITAL SOLUTIONS
02 - Sequence Verification
Ensure vectors are ligated correctly and that the sequence of interest is intact, readying vectors for raising a new cell line. Plasmids must undergo DNA sequencing to verify proper gene and vector element sequence after colony picking.
- Automate your sequence verification using the Beckman Coulter Life Sciences CosMCPrep Plasmid Purification Kit implemented using a Beckman Coulter Life Sciences Biomek i-Series Automated Workstation.
LABORATORY AUTOMATION | DIGITAL SOLUTIONS
03 - Stable Transfection & Selection
Incorporate vectors into genomes, creating new cell lines expressing mAb candidates. Gently recover cells and begin maintaining cultures. Verify that the incorporated insert has not mutated during the transfection and recovery process.
- Stably transfect vectors into cell lines to allow for the expression of the gene sequence producing the mAb.
- Automate the transfection and selection steps using a Beckman Coulter Life Sciences Biomek i-Series Automated Liquid Handler and Molecular Devices ClonePix 2 Mammalian Colony Picker, increasing reproducibility while minimizing the risk of contamination.
- Obtain cell count and viability data by integrating a Beckman Coulter Life Sciences Vi-CELL BLU Cell Viability Analyzer during cell recovery.
ANALYTICAL TOOLS | DIGITAL SOLUTIONS
04 - Pool Screening
Examine newly raised cell lines for desirable attributes. Screen for product expression, cell viability, and division. Automate subsequent verification and selection steps.
Screening selected pools of cells producing mAbs with required attributes including cell culture maintenance, imaging, and cellular analysis.
- Cell culture maintenance can be automated on a Beckman Coulter Life Sciences Biomek i-Series Automated Workstation while antibody titer is quickly assessed with the Beckman Coulter Life Sciences Valita Titer IgG quantitation assay and Molecular Devices SpectraMax plate reader.
- Pool screening and monoclonality assurance can be automated within a Molecular Devices ClonePix 2 Mammalian Colony Picker.
- Automated imaging can be performed on the Molecular Devices ImageXpress Pico.
LABORATORY AUTOMATION | ANALYTICAL TOOLS | DIGITAL SOLUTIONS
05 - Monoclonality Verification
Verifying that cultures originate from a single cell is a critical regulatory step and eliminates product heterogeneity. Regulatory bodies worldwide require images of cell cultures over time series to ensure cultures derive from a single cell and that products will not be heterogeneous.
- Automate limiting dilutions with a Beckman Coulter Life Sciences Biomek i-Series Automated Workstation, allowing you to make this inefficient and pipette-intensive task hands-off.
- Sort cells directly into individual cultures in a microplate with a Beckman Coulter Life Sciences CytoFLEX SRT Benchtop Cell Sorter.
- Acquire images from cell culture plates with a Molecular Devices CloneSelect Imager. Reporting can be easily automated or integrated into an existing cell culture workflow.
- Screen cultures and produce evidence of monoclonality with a Molecular Devices ClonePix 2 Mammalian Colony Picker.
- Data acquisition and management by the IDBS Polar Biopharma Lifecycle Management Software can ease regulatory compliance.
LABORATORY AUTOMATION | ANALYTICAL TOOLS | DIGITAL SOLUTIONS
06 - Selection based on Stability/Expansion
Grow and passage cell lines over time. Screen for and document product titer level and cell viability after each round of seeding and growth. Determine the most favorable media conditions and the hardiest clones. Advance with only the most robust cell lines and highest producers.
- Single cell lines are expanded across generations to screen for high productivity and stability. Select winners with Beckman Coulter Life Sciences Valita Titer IgG Quantification assay.
- Assess cell viability with the Beckman Coulter Life Sciences Vi-CELL BLU Cell Viability Analyzer.
- Automate assays using Beckman Coulter Life Sciences Biomek i-Series Automated Workstation and Molecular Devices SpectraMax microplate reader.
- Leverage the IDBS Polar Biopharma Lifecycle Management to capture and curate data for regulatory compliance and tech transfer.
LABORATORY AUTOMATION | ANALYTICAL TOOLS | DIGITAL SOLUTIONS
07 - Antibody Characterization
Analyze products for most desirable qualities such as structure, glycosylation, binding activity, and stability. Critical quality attributes such as mAb structure, activity, and stability are common targets for analysis.
- SCIEX BioPhase 8800 Capillary Electrophoresis system expedites mAb purity analysis and can be used to study consistency over time.
- The SCIEX ZenoTOF 7600 System provides an integrated and intuitive platform for mass analysis.
- Phenomenex Biozen HPLC columns are used for analytical separations and analyzing product attributes.
- Automate your sample prep with a Beckman Coulter Life Sciences Biomek i-Series Automated Workstation.
- Capture and manage your data with the IDBS Polar Biopharma Lifecycle Management Software.
ANALYTICAL TOOLS | DIGITAL SOLUTIONS
08 - Scale Up: Cell Growth/Expansion
Move cultures from small volumes to bioreactors and gather data on how cell lines tolerate bioreactor stresses and volume scaling. Prioritize developing cultures with best counts and viability over time. Defining optimal processes and cell culture parameters is critical for the tech transfer process and GMP manufacturing.
- Assess antibody titer with the Beckman Coulter Life Sciences Valita Titer Rapid high-throughput IgG quantification assay. This assay is amenable to automation on a Beckman Coulter Life Sciences Biomek i-Series Automated Workstation and Molecular Devices SpectraMax microplate reader.
- Cell viability can be assessed with the Beckman Coulter Life Sciences Vi-CELL BLU Cell Viability.
- Leverage the IDBS Polar Biopharma Lifecycle Management to capture and curate data for regulatory compliance and tech transfer.
LABORATORY AUTOMATION | DIGITAL SOLUTIONS
09 - GMP Master Cell Bank
Select final candidates for master cell banking and manufacturing. Preserve cell lines to create stocks.
- Master cell banks are generated from the highest-producing and stable cell lines.
- Prior to cryopreservation, measure cell viability and cell counts with a Beckman Coulter Life Sciences Vi-CELL BLU Cell Viability integrated with a Beckman Coulter Life Sciences Biomek i-Series Automated Workstation to create a sterile and closed preparation system.
- Capture the important metadata associated with your master cell bank using the IDBS Polar Biopharma Lifecycle Management Software.
DIGITAL SOLUTIONS
10 - Data Management
Data capture and proper handling are chief concerns during a drug development workflow. Across workflow steps, the IDBS Polar Biopharma Lifecycle Management Software can tie instruments and workflow processes together with data acquisition and management. Workflow solutions and instrument integrations for end-to-end biopharma lifecycle management make data handling and audit reporting easier.
Software
IDBS Polar Biopharma Lifecycle Management Software
IDBS Polar Biopharma Lifecycle Management Software is the world’s first BioPharma Lifecycle Management (BPLM) platform, eliminating repetitive manual tasks and allowing you to efficiently execute your processes. This enables you to curate the data you need to accelerate time to market by tackling the biggest challenges in process design, optimization, scale-up, and technology transfer.
Products
Explore Cell Line Development Products
Beckman Coulter Life Sciences
Echo 525 Acoustic Liquid Handler
Molecular Devices
QPix Microbial Colony Pickers
Beckman Coulter Life Sciences
Beckman Coulter Life Sciences Biomek i-Series Automated Workstation
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