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CHO · MAB

Monoclonal antibodies

Bring cell-culture records, process conditions, downstream recovery and analytical outcomes into one scientific context. Compare runs, investigate changes and evaluate the next process scenario using the evidence that supports it.

Monoclonal antibodies workflow from Cell culture, Harvest, Purification, Quality connected through Bio Hub, Bio Twin, Bio Agents and Bio OS

MODALITY-SPECIFIC PROCESS INTELLIGENCE

Connect culture performance to final product quality.

  1. 01Cell culture
  2. 02Harvest
  3. 03Purification
  4. 04Quality
SCIENTIFIC WORKFLOW

Culture development

Compare growth, viability, feed, nutrients and product accumulation across clones and culture conditions.

SCIENTIFIC WORKFLOW

Downstream recovery

Follow harvest, purification stages and chromatography evidence to understand where product or quality changes.

SCIENTIFIC WORKFLOW

Scale and transfer

Assess mixing, oxygen demand, equipment differences and operating windows with process-specific models.

SCIENTIFIC WORKFLOW

Quality investigation

Connect process events and batch comparisons to product-quality assays and evidence-linked hypotheses.

EVIDENCE · MODELS · DECISIONS

Keep every conclusion connected.

Evidence in Bio Hub

  • Cell growth and viability
  • Feed, metabolites and reactor conditions
  • Chromatography, recovery and quality assays

Models in Bio Twin

  • Culture kinetics and hybrid prediction
  • Feed and operating-window comparisons
  • Scale-dependent process assessment

Scientific decisions

  • Compare media and feed strategies
  • Investigate titer or quality shifts
  • Assess transfer and scale-up scenarios

Process outcomes to evaluate: Titer · recovery · product quality

EXAMPLE INVESTIGATION

Why did titer decline while the nominal setpoints stayed the same?

01

Connect evidence

Connect campaign runs with feed, material lots, metabolites, viability and reactor events.

02

Compare context

Compare the affected cohort with representative historical runs and aligned process phases.

03

Evaluate explanations

Evaluate plausible growth, nutrient and transport explanations; use calibrated model scenarios where appropriate.

04

Review next steps

Prepare a traceable comparison and recommend the experiment or measurement that would distinguish the hypotheses.

Bio Agents can coordinate the scientific work across evidence and models, while Bio OS preserves governance and human review. The configured workflow determines which tasks and models are available.

Bring us this process challenge ↗

EVALUATION & SCOPE

Make the demonstration specific.

Evaluate model fitness against independent runs, the intended operating range and the specific output. A model of titer does not automatically validate predictions of glycosylation or other quality attributes.

What evidence should we bring?

Cell growth and viability. Feed, metabolites and reactor conditions. Chromatography, recovery and quality assays. Include the process question, relevant run context and the analytical methods used to assess the outcome.

How do models support the workflow?

Culture kinetics and hybrid prediction. Feed and operating-window comparisons. Scale-dependent process assessment. Scope and evaluation criteria are defined for your process, data and intended decision.

What should we validate before using the results?

Evaluate model fitness against independent runs, the intended operating range and the specific output. A model of titer does not automatically validate predictions of glycosylation or other quality attributes.

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