1. Programme Background
The West Dublin manufacturing campus operates a sterile biologics facility supplying EU and US markets. Site utilisation exceeded 90% capacity following expanded therapeutic indication approval for a high-volume monoclonal antibody product.
Network capacity analysis identified upstream bioreactor constraints and downstream purification bottlenecks, creating a projected 18–24 month supply risk without expansion.
The expansion programme was initiated to protect commercial continuity, maintain regulatory compliance, and secure long-term manufacturing resilience.
2. Strategic Alignment
- Supports Global Manufacturing 5-Year Capacity Strategy
- Protects €180M annual EU revenue stream
- Improves supply continuity risk index by 22%
- Strengthens Ireland’s role as EU biologics centre of excellence
- Aligns with regulatory quality maturity roadmap
3. Business Case Summary
| Capital Investment | €180 Million |
|---|---|
| Capacity Increase | +38% Upstream Output |
| Revenue Protection | €180M Annually |
| Break-even Period | 3.5 Years |
| Net Present Value | Positive (Confidential) |
| Inspection Requirement | EU GMP + FDA Approval |
4. Programme Objectives
- Install two 20,000L stainless steel upstream bioreactors
- Expand downstream purification capacity
- Extend ISO 7 cleanroom footprint
- Upgrade utilities (WFI, Clean Steam, HVAC)
- Deliver full Commissioning, Qualification & Validation (CQV)
- Achieve regulatory approval within planned inspection window
- Maintain uninterrupted commercial production during works
5. Scope Definition
In Scope:
- Engineering Design (URS → FDS → Detailed Design)
- Construction in live GMP environment
- Long-lead equipment procurement & FAT
- Automation integration & Computer System Validation
- Full IQ/OQ/PQ lifecycle execution
- Inspection readiness preparation
Out of Scope:
- Process development modifications
- Global supply chain redesign
- Commercial packaging line expansion
6. Governance Structure
- Executive Sponsor – Global Manufacturing VP
- Site Sponsor – Ireland Operations Director
- Programme Director – Capital Programmes Office
- QA Lead – Site Qualified Person Representative
- Regulatory Liaison – HPRA Engagement Lead
- Financial Oversight – Corporate Capital Review Board
7. Stakeholder Matrix
| Stakeholder | Role | Influence | Engagement Model |
|---|---|---|---|
| Global Manufacturing | Capital Approval Authority | High | Monthly Executive Review |
| Site Operations | Production Continuity | High | Weekly Steering |
| Quality Assurance | Compliance Oversight | High | Risk Committee Cadence |
| Engineering & Automation | Technical Delivery | Medium | Integrated Master Schedule Governance |
| Regulatory Authorities | Inspection Approval | Critical | Pre-inspection Engagement |
8. Assumptions
- Regulatory inspection window remains fixed within Month 23–24
- Vendor delivery timelines maintained within contractual tolerance
- No significant GMP interpretation changes during build phase
- Utilities capacity modelling remains accurate within ±5% margin
9. Constraints
- Live GMP environment limits construction windows
- Highly specialised CQV labour market in Ireland
- Strict change control governance during PQ phase
- Fixed capital approval ceiling (€180M)
10. Milestone Plan
| URS Approval | Month 3 |
|---|---|
| Detailed Design Freeze | Month 6 |
| Equipment FAT Complete | Month 12 |
| Mechanical Completion | Month 17 |
| IQ/OQ Execution Complete | Month 20 |
| PQ Complete | Month 22 |
| Regulatory Inspection | Month 23 |
| Commercial Release | Month 24 |
11. Critical Success Metrics
- Zero production interruption events
- Schedule variance within ±3%
- Budget variance within approved contingency limits
- 0 Critical regulatory findings
- Go-live achieved within regulatory booking window
12. Approval
This charter represents formal authorisation to proceed with the capital programme subject to stage-gate financial governance and regulatory compliance requirements.