Detailed client case studies will be published here as they are cleared for release. In the meantime, these are the Z2 engagements clients most often ask for – and the questions each one answers.
Z2 Engagement 1
CLD strategy / programme review
The question: Is our cell line strategy right for this molecule, and will the clone hold up?
- Host/vector strategy, screening and clone selection
- Stability and clonality evidence
- Troubleshooting and independent CLD programme review
Z2 Engagement 2
Upstream development & optimisation
The question: How do we raise titre and consistency, and will the process scale?
- Media/feed optimisation and bioreactor development
- Scale-up/down and robustness
- Upstream CMC process understanding
Z2 Engagement 3
Technology transfer
The question: Can the receiving site reproduce our process?
- CLD/upstream knowledge transfer
- Gap assessment and comparability
- Receiving-site/CDMO readiness
Z2 Engagement 4
Technical due diligence & CMC regulatory review
The question: What are the technical risks before we invest, partner or file?
- Independent technical assessment and CMC risk review
- Scientific support for IND/BLA and regulatory documentation
- Red-flag reporting
Z2 Engagement 5
Laboratory & capability establishment
The question: What does it take to stand up a working development lab?
- CLD/bioprocess laboratory set-up and equipment
- Workflows, qualification and SOPs
- Operational readiness
Z2 Engagement 6
Biosafety, GMO & compliance readiness
The question: Are we ready – legally and practically – for GM work?
- Risk assessments and GMO/containment
- COSHH/BioCOSHH and H&S
- Associated compliance documentation
Z2 Engagement 7
Investment & fundraising support
The question: Will our technical case stand up to funders and investors?
- Scientific support for grants and investor materials
- Technical due diligence
- Investment-readiness assessment
Have a similar challenge? Talk to us about your programme.