SOLENTIM

ICON, POWERED BY STUDIUS

COMBINED HUMAN IgG1 TITRE, VCD AND PRODUCTIVITY ANALYSER

The smartest decision-making platform in cell line development

  • Make informed decisions faster and more securely
  • Streamlining ranking and selection of productive clones

TRANSFORM RANKING OF YOUR
FED BATCH SUSPENSION CULTURES

ICON is a single, multifunctional instrument that enables the triage of clones via low volume titre and viable cell assays.

STUDIUS incorporates critical data from Solentim’s VIPS™ single cell seeding, Cell Metric® clone verification and colony outgrowth monitoring and ICON™ cell IgG productivity assessments. This provides a unique decision-making platform for the cell line development workflow.

Rank best producers quicker, without risk of error

In the STUDIUS powered ecosystem, ranking and decision-making are performed automatically and instantly, according to user defined parameters.  ICON can uniquely triage clones via low volume titre and viable cell assays on one instrument and combines results with confluence and clonality data from Cell Metric® and/or VIPS™ within STUDIUS.

Track clones from seeding to selection

Samples are tracked throughout the cell line development process from seeding to selection to capture the journey of each individual cell.

Easy regulatory compliance

STUDIUS spans across the cell line development workflow with features such as sample tracking, audit trails and multi-level password protected user access providing a toolkit for easy compliance with 21 CFR part 11, Annex 11 and other guidelines. Reporting is easy with automatically created reports of clonality.

Track every moment:

From seeding, evidence of clonality, growth, productivity through to selection

HISTORYTREE™ graphically represents a cell’s journey through cell line development, independent of sample formats.  From seeding, through growth, productivity assays, ranking and selection, coloured nodes represent time points in the cell’s journey offering easy access to critical data and an audit trail.

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STUDIUS Data Management Platform

Enhanced CLD workflows for IND success

The Solentim Ecosystem

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Features

Combined hIgG1 titre, VCD and productivity data on one instrument

The ICON with STUDIUS can uniquely measure both titre and viable cell density in the same instrument. Automatic ranking of best producers is performed easily according to user defined parameters.

Instant, error free clone stratification and selection

Combine VIPS seeding and Cell Metric clonality data with ICON titre measurements in order to automatically select your best performing clones and avoid laborious comparison of results files.

High throughput, rapid, low volume assays

20 – 60 μL samples enable measurements much earlier in your fed-batch process for faster and more confident decision-making.

Track and rank clones automatically

Samples are tracked across your workflow from the cloning plate, through fed-batch suspension shaking cultures to shake flask and multi-parallel mini bio-reactors such as AMBR. For automated liquid handlers, STUDIUS communicates source and destination locations to the robot ensuring consistent sample tracking.

A common data management platform that ensures data integrity

In the STUDIUS ecosystem, raw data results from all Solentim instruments go directly and securely without external manipulation into a single common database for ultimate data integrity.

Rapid, low volume productivity

Titre is measured using fluorescence polarisation and needs only 60 μL per assay.  This means that titre can be measured earlier in the process, for example in Day 14 static cloning plates or 48 /24 deep-well suspension shaking plates. Earlier titre measurements allow earlier stratification of high producing clones.

Rapid, low volume cell viability

Viable cell density is measured using Trypan blue exclusion.  Cultures up to 107 cells/mL can be counted and the count is qualified with a supporting high resolution image showing the denotation of live versus dead cells.  The assay requires only 20 μL of sample, much less than incumbent cell viability analysers requiring several hundreds of microlitres.

A common CLD data management platform eliminates error

STUDIUS provides consistency across the cell line development workflow via secure sample/clone tracking through a common database, eliminating cumbersome and error prone comparison of results in various formats from multiple suppliers instrumentation.

The current paradigm in cell line development involves comparison and cross referencing of excel spreadsheets containing for example, clonal outgrowth and productivity results.  This tedious process increases the risk of error and reduces confidence in the overall clone selection process.  STUDIUS manages results from Solentim’s cell line development instrument portfolio, thus eliminating time consuming and error-prone visual comparison of data in different formats.

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RESOURCES

ICON System

Combined human IgG1 titre, VCD and productivity analyser

The ICON with integrated STUDIUS data management platform enables scientists in the biotherapeutic development industry to digitally transform their process and make informed decisions quicker, earlier, and more securely.

STUDIUS Data Management Platform

The smartest decision-making platform in cell line development

The STUDIUS powered ecosystem provides a more consistent cell line development workflow for scientists creating biotherapeutic Master Cell Banks, enabling faster and more confident decision making.

STUDIUS Data Management Platform

APPLICATION notes

Improving CLD processes through accurate, low volume and rapid automated cell counting

Continuous Audit Mode (CAM) on Solentim’s STUDIUS data management platform

How the Solentim Ecosystem is tackling data consolidation and reporting in CLD

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