Customized Cell Line Development Solutions for Your Unique Processes

A Tailored Approach to Cell Line Development 

Bringing a biologic to market depends on smart cell line development strategies. You need to balance the control and speed of an in-house solution with the convenience and flexibility of outsourcing. Sartorius offers a suite of innovative products and services that can be tailored to your operation.  Whether you need instruments, consulting, or development and testing services, partnering with Sartorius can accelerate your cell line development and ensure a smooth transition to commercial manufacturing. 

Maximize Your Strengths

Choose just the right products and services to complement your core strengths

Maintain Flexibility 

Leverage the right people and products when and where you need them

Streamline to a Single Vendor 

A single-vendor approach simplifies management and administrative activities

Accelerate Your Cell Line Development at Every Step 

Producing biologics is complex, and cell line development is no exception — tight timelines, constant cost pressure, and time-to-market are top of mind. Starting with customizable solutions from Sartorius gives you the flexibility to select what’s right for your therapeutic development.  

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Conquer the High-Stakes Climb to Successful Cell Line Development

Cell line development is vital to biologics manufacturing, but the journey is time-consuming, expensive, and requires dedicated expertise.

Read Blog Post  All CLD Blog Posts 

Gene Cloning and Initial Clone Selection

Accurate, Rapid Cloning and Initial Clone Selection

We offer instruments and technologies to assist with transfection and clone selection. Our innovative solutions enable rapid selection of top pools after gene cloning and can help evaluate overall clone performance, from protein concentration to cell health and viability.

iQue® cell and bead-based kits allow for simultaneous screening for IgG titer and cell health attributes.

Quantitate Cell Count and Viability Efficiently and Accurately

Use cell count and viability information to select the best pools. The iQue® Advanced Flow Cytometry Platform provides accuracy across a large linear range in 96- and 384-well plates and reproducible analysis of absolute cell count and viability data from a variety of non-adherent cell lines with a streamlined workflow, from cell labeling to analysis, with no cell dilution required. 

  • An integrated instrument, software, and reagent system for rapid, multiplexed analysis 
  • A unique patented sample introduction method that minimizes sample size requirements 
  • Deliver content-rich results in just minutes

Learn More About iQue® Platform

Sartorius offers a ready-to-use solution with all of the necessary components for customers who prefer to develop cell lines.

Ready-to-Use, High-Performing Cell Line

Cell line development is a complex process, requiring consistency and reproducible results. Sartorius offers a ready-to-use solution with all of the necessary components for customers who prefer to develop cell lines and express their proteins of interest in their own facilities. The Cellca CLD Technology License is based on the industry-leading Cellca Cell Line Development Technology and uses CHO DG44 host cells. Because the technology license eliminates the need for further development or optimization, it significantly reduces development time and costs.  

  • Ready-to-use solution
  • Well-performing cell line
  • Reduced time and financial investment

Learn More

Octet® BLI is an easy-to use, real-time analytical tool that rapidly screens critical quality attributes.

Easy Titer Determination of Active Analyte

Replace ELISA and HPLC with Octet® Label-Free Detection Systems for quantitation of antibodies and recombinant therapeutic proteins. Accurate and fast assays in real-time are easy to develop and transfer to QC and process development. 

  • Analyze a full plate (96-samples) of IgG titer in as little as two minutes 
  • Assay directly in crude and unpurified samples 
  • Optional automation for walkaway high-throughput analysis

Learn More

Incucyte® Live Cell Analysis uses whole-well, label-free imaging to scan clones and verify monoclonality.

Monitor Transfection Efficiency 

Monitor and quantify the efficiency and time course of gene transfection using green fluorescent protein (GFP) and red fluorescent protein (RFP) markers. Incucyte® Live Cell Analysis Systems use integrated image processing to identify wells containing emerging colonies.

Learn More About Transfection Efficiency Monitoring

The unique Cellca Cell Line Development technology offers speed, flexibility and scalability.

Produce a High-Quality, Antibody-Secreting Clone Using a Proven Process 

Sartorius’ cell line development services are targeted to large-scale production of biopharmaceuticals in mammalian cells, primarily Chinese hamster ovary (CHO) cells. The unique Cellca Cell Line Development service offers speed and flexibility, with a track record of performance and scalability. 

  • From DNA to fully characterized RCB in 14 weeks 
  • More than 120 projects successfully completed  
  • Save 3 months by omitting scalability studies 
  • Easy and direct scalability from small scale to 2000 L 

Learn More About CLD Services

Cell Line Selection and Confirmatory Analytics 

Expansion and Screening to Identify the Highest-Performing Clones 

Early screening of product quality attributes in addition to quantity can facilitate the selection of clones to avoid late-stage failures. Ensure success by selecting the best clones based on quality and quantity using our instruments and package of ready-to-use assays and platform method.

Accelerate antibody discovery by combining Octet® titer data with sialic acid or mannose data for more insight.

High-throughput Glycan Screening and Protein Quantitation  

Accelerate antibody discovery by combining titer data with sialic acid or mannose data for more informed decisions. Our glycosylation kits can screen and quantify proteins in crude and purified samples. 

  • No sample purification or digestion required 
  • Reduce preparation time up to 3 hours  
  • Screen for samples with desired glycosylation profiles 
  • Prevent late failures by moving higher-quality candidates downstream  

Explore Octet® Glycosylation Kits


iQue® cell and bead-based kits allow for simultaneous screening for IgG titer and cell health attributes.

Rapidly Screen Antibody-Producing Clones 

Combine IgG quantification, cell counting and viability measurement in a single well without sample dilution. Quickly and efficiently learn critical productivity attributes for each clone: 

  • More insight for better clone selection 
  • More critical productivity attributes  
  • More clones screened in less time 

Discover iQue® Cell and Bead-Based Kits

Incucyte® Live Cell Analysis uses whole-well, label-free imaging to scan clones and verify monoclonality.

Confirmation of Monoclonality 

Use whole-well, label-free imaging to automatically scan for clones and verify monoclonality. Integrated image processing identifies wells containing emerging colonies, allowing for the rapid identification of clones of interest. 

Learn More About Dilution Cloning

Cell Line Cultivation and Media Optimization 

Quickly Produce Higher Protein Titers

Improved culture conditions and enhanced culture analysis give rise to optimized cell environments that maximize cell growth and metabolism. Sartorius offers a range of products and expertise to help you improve productivity and quality, enhance stability and reduce cost.

Discover how Sartorius experts perform media optimization within the Cell Line Development process.

Quickly Produce Higher Protein Titers  

Process parameters, cells and cell culture media interact in a challenging way to define the productivity and quality of the protein output. Sartorius ensures you get it right the first time, providing process-integrated media services to benefit your upstream process and reduce your time-to-market. 

Explore Media Optimization

Ambr® 15 increases productivity in cell line development with significant savings on materials and labor.

Rapid Evaluation of Multiple Bioreactor Cultures at Microscale 

The leading bioreactor system for cell line development and process optimization, Ambr® 15 allows parallel operation of up to 48 single-use microbioreactors (10-15 mL) controlled by an automated workstation. It increases productivity in cell line development with significant savings on materials and labor. 

  • Proven industry-standard microbioreactor for cell culture 
  • Better scale-down model than a shake flask 
  • High throughput and cost-effective 

Discover Ambr® 15 Cell Culture 

Octet® BLI rapidly determines recombinant protein concentration as a control parameter in cell line development.

Rapidly Determine Recombinant Protein Concentration as a Control Parameter  

The Octet® BLI platform is an easy-to use, real-time biologics analytical tool that requires no labeling and enables rapid screening of critical quality attributes earlier in the decision-making process. 

  • Monitor titers before and after new conditions are introduced — e.g., supplements in cell growth media 
  • Measure directly in unpurified samples such as cell culture supernatants  
  • Process the sample plates further, thanks to non-destructive measurement 

Learn More About Protein Analysis


iQue® cell and bead-based kits allow for simultaneous screening for IgG titer and cell health attributes.

Simultaneous Screening for IgG Titer and Cell Health Attributes 

Combine IgG quantification, cell counting, and viability measurement in a single well without sample dilution. Quickly and efficiently learn critical productivity attributes for each clone: 

  • More insight for better clone selection 
  • More critical productivity attributes  
  • More clones screened in less time 

Learn More About Bioprocessing

Use DOE and MVDA to characterize and optimize cell culture conditions.

Use DOE and MVDA to Characterize and Optimize Cell Culture Conditions

Umetrics® Suite helps you to quickly identify the optimal bioreactor and media conditions to achieve high protein titers.
MODDE® makes Design of Experiments (DOE) easy, allowing you to efficiently plan and analyze culture experiments.
SIMCA® lets you use Multivariate Data Analysis (MVDA) to understand correlations in multiple cell culture parameters as part of a Quality by Design (QbD) approach for scale-up.

  •     Reduce the number of experiments while maximizing information
  •     Quickly identify critical process parameters (CPPs)
  •     Increase process understanding
  •     Identify robust and optimal conditions (design space)

Learn more about Data Analytics

Cell Line Evaluation and Characterization 

Quantify Protein of Interest and Screen Critical Quality Attributes

A suite of instruments and services evaluate selected clone(s) for contaminants, viruses, sterility, and protein production. A key aspect is defining Critical Quality Attributes (CQA) and monitoring these closely to ensure the characteristic attributes of the protein remain intact.

Octet® BLI rapidly determines recombinant protein concentration as a control parameter in cell line development.

Rapidly Quantify the Protein of Interest and Screen Critical Quality Attributes 

The Octet® BLI platform is an easy-to use, real-time biologics analytical tool that requires no labeling and enables rapid screening of critical quality attributes earlier in the decision-making process. 

  • Titer determination of active analyte
  • Evaluate critical quality attributes (CQAs) such as glycosylation profiles
  • Monitor product quality and stability during process development

Discover  Octet® BLI Platform


iQue® cell and bead-based kits allow for simultaneous screening for IgG titer and cell health attributes.

Simultaneous Screening for IgG Titer and Cell Health Attributes 

Combine IgG quantification, cell counting and viability measurement in a single well without sample dilution. Quickly and efficiently learn critical productivity attributes for each clone: 

  • More insight for better clone selection 
  • More critical productivity attributes  
  • More clones screened in less time 

Discover iQue® Cell and Bead-Based Kits

Cell Banking 

Cell Banking Platform and Services to Create a Single Source for Manufacturing

Fully characterized, documented, homogenous master cell banks and working cell banks are critical to mitigate risk and ensure product safety and quality. Sartorius CHO cell banking platforms allows technology transfer of your own cell culture parameters without the need for engineering or pilot runs for an easy pivot to cGMP manufacturing.

Sartorius CHO cell banking platform allows technology transfer of your cell culture parameters without engineering.

Closed-System Cell Bank Manufacturing Platform 

Our experienced team offers you the flexibility to do your cell bank manufacturing with us. Sartorius CHO cell banking platform allows technology transfer of your cell culture parameters into the platform without engineering or pilot runs.  

  • Dedicated cGMP facility 
  • Standard >500 vials, 12 x 106 viable cells/cryovial 
  • Closed and automated single-use 
  • Flexibility of transfer to any CMO 
  • Qualified Person (QP) batch release 
  • FILL-IT® automated filling: 500 vials in 20 minutes 


Explore Cell Banking

Discover our ready-to-use testing packages to existing drug development risk strategies or customize them.

Cell Bank Biosafety Testing and Characterization Packages 

Add ready-to-use testing schemes to existing drug development risk strategies or customize them. Sartorius QC testing plans meet mammalian cell bank release requirements and ICH Q5A regulations with GMP-validated assays. Sartorius has performed testing on over 200 CHO cell banks, so you can count on our experienced scientists to recommend the most suitable — and cost-effective — testing strategy to meet regulatory requirements.   

  • Expand QC workbench capacity and scientific expertise 
  • Accelerate time to market with rapid PCR or ELISA assays  
  • Gain access to testing experts 

Discover Cell Line Characterization


Supporting Products/Solutions

Picus® Electronic Pipette

Multichannel pipettes consistently and ergonomically deliver precise and accurate volumes.

Discover Electronic Pipettes

Related Resources

Explore Our Related Resources for Cell Line Development  

Sartorius is a leading provider of cell line development solutions and services targeted to large-scale production of biopharmaceuticals in mammalian cells. Keep reading below to learn how we can help you on your journey to a master cell bank.

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Cell Line Development Webinar Series

Learn strategic approaches, best practices, critical considerations, and expert insights on-demand.

Browse CLD Webinars

Featured Resources

eBook: Strategies for Effective Cell Line Development

Learn how early, data-driven decision-making can impact later stages of development and how to accelerate CLD workflows.

Download eBook

Improving Efficiency in Cell Line Development: Infographic

Download Infographic
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Webinar: Effective Cell Line Development

Reducing Risk, Decreasing Timelines, and Optimizing Outcomes

Watch Now
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Critical Steps for Protein Potency Assay Development

Learn from a Sartorius expert the process of assay development, qualification, and validation for potency assays and how Sartorius supports customers...

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Accelerating Process Optimization by Combining Cell Culture With Titer...

Cell line development (CLD) involves the screening of thousands of clones to find those that are stable, produce high yields of the bioproduct, and ha...

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White Paper

A Guide to Accelerating Cell Line Development for Commercial Prod...

PDF 2.4 MB

Analytical Power Tools Open Upstream Bioprocessing Bottlenecks

The blockbuster success of antibody-based therapeutics for autoimmune diseases, inflammatory diseases and immuno-oncology accelerated the high stakes...

Download White Paper

Resources

Application Note

Optimization of the HEK293T Suspension Cultivation With a DOE-Approach in Ambr® 15 Cell Culture

PDF | 2.2 MB
Application Note

Critical Sample Preparation to Concentrate Hybridoma Supernatants

PDF | 213.9 KB
Application Note

Quantitatively Screen Bispecific Antibodies Using Protein A and Octet® His1K Biosensors

PDF | 737.4 KB
Application Note

Quantify Igg Isotype, Igg Quantity per Isotype,  Secretion, Cell Count/Health

PDF | 1.5 MB
Brochure

Ambr® 15 Cell Culture Generation 2

PDF | 3.8 MB
Brochure

Ambr® 15 Cell Culture Generation 2

PDF | 5.2 MB
Brochure

Ensure your confidence in every stage of discovery and development 

PDF | 3.8 MB
Octet GlyM Kit datasheet
Datasheet

GlyM Kit Datasheet

PDF | 781.3 KB
Datasheet

Mycoplasma Detection with Microsart® Mycoplasma qPCR Kits ensure validated test results in compliance with international standards 

PDF | 617.3 KB
White Paper

How DoE and MVDA Improved Scale-Up Performance at a CDMO

PDF | 1.8 MB
Octet GlyM Kit Technical Note
Technical Note

GlyM Kit Technical Note

PDF | 2.2 MB
eBook

Overcome high density cell culture harvesting issues

PDF | 2.2 MB

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