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Integrated upstream development support linking cell biology, media, process conditions, process understanding and scale-up to robust and manufacturable biologics processes – across fed-batch and perfusion development and process intensification.
Media, feeds and process parameters are developed together, so the process behaves the same at 2 L and at 2,000 L.
What we do
- Shake-flask and bioreactor process development
- Seeding and feeding strategies and media/process integration
- Fed-batch and perfusion development, process intensification
- Critical process parameter identification and robustness assessment
- Troubleshooting growth, viability, productivity and consistency
- Scale-up, scale-down and DoE-based optimisation
The market now
4 → 10 g/L
One antibody process, by optimising feed, then medium, then pH and temperature1
<10%
of approved biologics use perfusion or continuous processing2
~35%
lower peak antibody titre after extended passaging in one CHO stability study3
Where rushed timelines break
Scale-up before the process is understood.4
Where Z2 helps
DoE-led media, feed and parameter work, and a qualified scale-down model before you scale.
Sources
- Intracellular response to process optimization, high-titer CHO process. PubMed 28941283.
- BioPharm International. Continuous manufacturing: a changing processing paradigm (BioPlan estimate).
- Exploring CHO cell stability during prolonged passaging via explainable AI-driven flux balance analysis. PMC12992790.
- BioPharm International. Current challenges with cell culture scale-up for biologics production.
