Intelligent From the Start — Instruments for Cell Line Development
Innovative Technologies to Select the Right Clone
Sartorius provides innovative, high-throughput and automated solutions for early development of dedicated cell lines. Instruments to identify top-performing cell lines with the optimal critical quality attributes (CQAs) can not only achieve high yields of recombinant proteins, but also smooth the transition to commercial manufacturing. Eliminate process bottlenecks by investing in the most advanced technologies for cell line selection, characterization, and cell bank preparation.
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Discover how Sartorius’ innovative products and expert knowledge can provide an efficient and scalable solution to CLD
Early prediction of the best-performing clone means you can get it right, right from the start.
Advanced tools to enhance your cell line development.
High-throughput systems reduce cost and shorten timelines for stable, scalable, productive cell lines.
For high yields of recombinant proteins for therapeutic applications, stable, scalable and high-titer cell lines are needed. With advanced techniques and technologies from Sartorius, you can accelerate cell line selection and development, so you screen more clones faster and make decisions sooner.
The CellCelector single cell and colony picking platform is used for high-throughput single cell cloning, allowing fast generation of clonal production cell lines. Integrated image-based monoclonality proof and clone viability assessments - combined with high outgrowth rate after clone transfer to 96- or 384 well plates - the CellCelector is the leading alternative to limiting dilution or FACS single cell sorting techniques.
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The iQue® 3 High-Throughput Cytometry Platform with iQue® Human IgG Titer and Viability Kit provides greater insight into production clone ranking and selection, with rapid and simultaneous evaluation of IgG titer, specific productivity, and cell health.
1uL minimum sample volume requirement in a 384-well format with zero dead volume. Cell detection at rates of thousands of cells per second
Multiple readouts for every event
Natural conformation of cells and targets
21 CFR Part 11 Software Module
Explore the iQue® 3 Platform
Octet®️ Label-free Bio Layer Interferometry (BLI) technology uses optical biosensors to measure protein-protein interactions in parallel, without the use of detection agents. This robust and fluidics-free approach enables fast characterization of expressed proteins even in complex and unpurified samples in real-time.
Explore Octet® BLI Label-Free Detection System
The leading microbioreactor system for cell line development and process optimization, allowing parallel operation of up to 48 single-use microbioreactors (10-15 mL), controlled by an automated workstation.
Explore Ambr® 15
An automated, high throughput benchtop system that performs a one-step clarification and purification process to streamline and automate mAb cell culture harvest coming from Ambr® 15 and other suspension cell cultures.
Explore StreamLink® CC 15
The Fill-It system helps create cell banks for drug discovery, screening operations and GMP production. It rapidly dispenses cell suspensions, strains or reference standards from bulk stock into the screw-cap cryovials before recapping them.
Explore Fill-It
Learn how Sartorius’ bioanalytical technologies fulfill critical needs along the entire span of the CLD workflow, including measuring CQAs.
Learn strategic approaches, best practices, critical considerations, and expert insights on-demand.
High-throughput nanowell-based image-verified cloning technology generates clones in just one round while providing proof of monoclonality.
Accelerate Process Optimization by Combining Cell Culture with Titer Measurements.
Reducing Risk, Decreasing Timelines, and Optimizing Outcomes
This application note describes the power of using the Octet® platform along with Ambr® 15 Cell Culture to identify optimum yield conditions.
A novel approach for relative mannose content screening and ranking of human monoclonal antibody (mAb) samples using the Octet® GlyM Kit
A Novel Solution to Expedite Antibody Discovery
Accelerating Antibody Discovery by Monitoring Titer and Glycosylation With the Octet® Platform
This listicle outlines what CQAs should be measured and when, as well tips and solutions for optimizing measurements.
No, Octet cannot separate charge variants of antibody from glycosylation. Octet Glycan screening kits (GlyM and GlyS) are lectin based and recognize specific sugar moieties, but not charge variation.
Yes, you can. This is a typical application in a process screening application and determine most sensitive factors and find suitable ranges. Often, this could be followed up on with more detailed studies using an Ambr® 250 for easier scale-up.
During ambr15 runs, daily cell sampling is necessary to track both cell count and viability. The iQue® Cell Count and Viability kit is perfectly designed for the reproducible analysis of cell count and viability to screen and profile cells. The small sample size (1 uL) necessary allows for the preservation of precious sample and this coupled with the streamlined workflow allows for rapid determination of the health of each culture.
The iQue® Human IgG Titer and Viability kit together with the iQue® 3 High-Throughput Cytometry Platform can be used to calculate titer. One of the key benefits of this kit is that it provides such metrics as IgG quantitation per viable cell. The iQue Forecyt® software is capable of automatically ranking this data to allow the user to make informed decisions on clone selection. The detection range of 0.6 ug/mL to 20000 ug/mL makes it more suitable for early-stage cell line development including clone selection. There is also a mouse version of this kit available too.
Yes, you can. For example, you can also use Protein L-based sensors suitable for certain antibody fragments. In addition, you can quantify certain glycan classes like mannosylated and sialylated species.
Fortunately, for this assay you are mostly using diluted samples (about 10-20x), which reduces the impact of any matrix effects. Still, if you would like to assess any potential impacts, we recommend performing standard addition studies to quantify.
Critical quality attributes (CQAs) of cell lines include identity, microbiological sterility, genetic fidelity and stability, and viability. In terms of characterizing the biopharmaceutical product the CQAs are extended to potency, and biological activity. The later includes the glycosylation pattern, which has implications on the half-life, immunogenicity, and pharmacokinetics of the biologic, and must be closely monitored throughout drug development and manufacturing.
Are you tired of seeding thousands of cells in large stacks of cell culture plates only to find out they are either no single cells, viable or productive? Tired of screening hundreds of plates for the one clone that has it all and will fulfill your projects titer goal? Why leave your pharmaceutical cell line development to chance? With the CellCelector single cell and colony picking platform you can now effectively assess and verify your clones before deciding which ones to choose. Within under a week you will get from a pool of single cells to plates full of clones that have proven to be monoclonal, viable and productive. Instead of relying on large quantities of plates to produce a winner you can now use actual data reliably predicting the future of your clones. This saves consumable and media costs, incubator space but most of all valuable time to reach your project goals by avoiding missteps, a second cloning round and unnecessary procedures.
Automated monoclonality proof: robust single cell detection in nanowells.
In a conventional single cell cloning workflow single cells are seeded in 96 well plates making reliable automated single cell detection in bright field difficult as cells are often settled at the very edge of the well. Thus, the monoclonality status of a given clone at day 0 is usually checked manually or retroactively once the clone has grown. But why search a single cell within a well area that is more than 100 times larger than the surface occupied by a cell? With the CellCelector HT-NIC approach the cells are separated and clearly visible within 200 µm large nanowells and can therefore be identified reliably and automatically by software. Even just after seeding or when they touch the nanowell border.
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