Titer in CHO cell culture depends on interacting parameters such as dissolved oxygen and pH setpoints, feed timing and seeding density, and each combination's effect is often known only after a full run. INSUS learns from your cultivation and QC data to predict titer before a run. Bioprocess teams keep change control.
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Predictions come before bioreactor time is committed.
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Read-only. Nothing is written to the control system.
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Every recommended run stays a change-controlled decision.
The problem
Final titer results from many parameters acting together. Dissolved oxygen and pH setpoints, pH shift timing, viable cell density, feed timing and glucose concentration can all matter, and they interact. Combinations multiply faster than design-of-experiments campaigns can cover, so suite capacity often goes to conditions tuned from experience while higher-titer settings are never systematically explored.
The shift
Experiments stay essential and change control stays in place. What changes is which candidate conditions are scored before bioreactor time is committed.
Today
With INSUS
How it works
This fits OptiStudio as bioprocess decision support beside existing bioreactor control, batch records and LIMS. Access is read-only. The team decides what gets run.
Connect
Connect read-only to the bioreactor control system and historian for DO, pH, feed timing and concentration and viable cell density; MES or batch records for process parameters; and LIMS titer and analytical results.
Understand
Analyze which parameters most influence final titer for this cell line and process, and how they interact, from your own development and manufacturing history.
Predict
Predict the likely final titer of a candidate parameter combination before the run. Candidates outside the training range are flagged as extrapolations for experimental confirmation.
Advise
Put forward parameter combinations expected to improve titer for review. Process development or manufacturing teams decide whether to run each one under existing change-control practice.
Verify
Compare predictions with actual titer from runs that are carried out, with other critical quality attributes tracked alongside, so the model can be refined for that cell line.
Getting started
For bioprocess teams with CHO or similar cell culture history. Delivered through OptiStudio as upstream decision support. Expert Services can help with data assessment and validation. Advisory and read-only. Models are built for one cell line and process at a time.
Related for biotech
Cell culture titer optimization sits beside AAV affinity purification optimization and Annex 1 contamination control strategy on the same biologics operation.
Titer depends on many interacting parameters, so full experimental screening is slow. This use case predicts likely titer for candidate combinations before a cultivation run for bioprocess-team review.
Historical bioreactor process parameters with corresponding titer and QC results across a representative range of conditions. No new hardware when control, batch record and LIMS data already exist.
No. The team reviews every proposed combination and decides whether to run it. Access to bioreactor control systems is read-only.
It can flag extrapolated candidates. Those are hypotheses to confirm experimentally, not settings to adopt without runs and QC review.
Parameter changes remain human and change-controlled decisions. Any change affecting GMP manufacturing follows your validation and change-control requirements.
Through OptiStudio as bioprocess decision support. Expert Services can support data assessment, integration and validation with your development team.
Performance depends on enough parameter variation in historical runs. Published cultivation modeling studies are not INSUS results for your cell line. Other critical quality attributes must be assessed alongside titer.
Biotech · Upstream cell culture
Start with a data assessment on one cell line: whether your process and titer records span enough parameter variation to predict from, and what the model would have said about runs you have already done.
