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Programmes stall in predictable places. Each problem starts early – at the clone, the transfer, the lab or the diligence – long before it shows. Z2's approach is to find and tackle those risks at source, with the judgement of someone who has seen where early development decisions lead.
Where programmes stall
Across more than 200 FDA complete response letters issued 2020–2024, CMC and facilities accounted for 29.1% of all deficiencies cited – more than clinical safety (13.4%) or efficacy (10.9%).1
01
Stability
Clones that don't hold: productive at screening, losing titre by the bioreactor.
02
Reproducibility
Processes that don't travel: developed at 250 mL, won't reproduce at the receiving site.
03
Scalability
Assets that can't scale: the process limit surfaces in due diligence, not development.
04
Infrastructure
Labs built without a map: capability stood up with no prior experience of what it takes.
What's needed, at source
Stability-led clone selection
Clone-selection, stability and clonality criteria agreed before a CDMO starts – not after the package reaches the regulator.
Predictive scale-down models
Media, feeds and process parameters developed together, so the process behaves the same at 2 L and at 2,000 L.
A CMC plan set up front
A plan, budget and risk register that reviewers, investors and CDMOs can check line by line.
Senior PD on demand
Experienced process development leadership without a permanent hire – when 36% of facilities report they cannot hire PD staff.2
Principles we work by
- Industrial development lens from the first experiment
- QbD, DoE, scale-down models and process characterisation
- Smarter experiments over more experiments – data, MVDA and AI/ML
- Capability building: labs, workflows and trained teams
- Independent, evidence-based assessment of risk and readiness
The objective is to move development beyond simply "running more experiments" towards designing smarter experiments, extracting more knowledge from existing data and making better development decisions earlier.
Sources
- Parexel. Understanding FDA complete response letters: why CMC readiness must become a strategic priority, June 2026. 'Other' categories (46.6%) not shown.
- BioPlan Associates. 22nd Annual Report and Survey of Biopharmaceutical Manufacturing Capacity and Production, April 2025.
