Archived - This content has been developed for the transition binder for the NRC Acting President, September 2020
| Security classification: | PROTECTED B |
|---|---|
| Not for further circulation | |
This is a weekly update report on progress of the Biomanufacturing Vaccine Facility Project
Facility build and design
Progress update
- Milestones advanced:
- Fire line relocation and storm sewer installation ongoing (late) pending on the Street Cut Permit. The permit was received and the street cut will be completed the week of Sept. 28.
- Formwork and concrete pour for foundation wall is progressing as planned.
- Rock anchor design and fabrication is progressing as planned.
- Network installed, waiting for [REDACTED] to access to camera.
- M. Aubrey to approve three small scope changes contracts. Meeting with [REDACTED] is scheduled for this week to review the scope change.
- Positive meeting with Health Canada (HC) to review BVF design lay out and approve approach as required for GMP facility, took place on Sept. 18th. HC to review lay outs week of Sept 21 and provide feedback if/as applicable. Meetings will take place regularly. Next Meeting is scheduled for Sept. 30.
- The Purchase Requisition to amend the [REDACTED] contract for interior Fit-out was sent to PSPC.
Upcoming decisions
- Nil
Equipment & procurement
Progress update
- Milestones advanced:
- Onboarding of two additional procurement resources on assignment from DND started Sept 14.(completed)
- Meeting to be held week of Sept. 23 with Shared Services Canada to discuss IT/ Automation procurement options for the BVF to meet GMP requirements. Follow-up meeting will be held on regular bases.
- PMO drafting the Project Procurement Strategy for submission week of Sept 21 to support how procurement will be achieved while addressing the requirement for competitive process and transparency.
- RFP for automation integrator ongoing. RFP to be developed for software procurement for ERP and LIMS.
- POs for the Tanks to be issued next week.
Upcoming decisions
- Nil
Governance
Progress update
- Steering Committee: 5th Steering Committee meeting scheduled for September 24th.
- Project Advisory Board: Terms of Reference shared with President's Office on Sept. 17th for President review.
- BVF Operations:
- M. Aubrey working closely with HR to develop the BVF operations HR strategy. Meeting with Operations working group on BVF operations HR resourcing needs held on Sept. 18. A revised org structure of key positions along with the HR Resourcing strategy are to be completed week of Sept 21.
- In parallel an RFP is being drafted to outsource the documentation, validation and qualification of equipment.
- [REDACTED] working on development of Opex costs both for the interim and the ongoing operations of the facility.
- As part of this process, will be the identification of media, materials and supplies required and the sourcing approach also required for the Oct. 16 meeting with the President. Material will be shared with the President's Office in first week of October for the meeting.
Upcoming decisions
- BVF operations HR resource strategy to be provided to President by Sept 25.
Policy
Progress update
- Communications: BVF Policy team working with Comms and SRPA to develop Communications and Stakeholder Relations plan for NFP. Discussed approach to begin market assessment/intelligence gathering on potential NFP organizations – via a call for "Expressions of interest".
- Comms will support creation of communications package for marketing the BVF facility to stakeholders and potential NFP contenders and tracking approach on interest in the NFP opportunity.
- Machinery of Govt:
- Final TB Submission, BN and Late Letter shared with M. Aubrey and President's Office on Sept. 15 – received greenlight from TBS Sept. 16 and [REDACTED].
- PCRA updated in Callipers and confirmed Level 2 by TBS Sept. 16.
- TBS OCG confirmed Sept. 17 that they are satisfied the NRC has the delegation from PSPC OCG contracting to procure goods in the case of an emergency.
- Stakeholder Meetings:
- Meeting to be held on Sept 21 with ISED (G. Bujold) to provide overview on BVF project and discuss biomanufacturing governance strategy.
Upcoming decision
- [REDACTED].
Business strategy
Progress update
- NFP Governance & Business Models:
- M. Aubrey and BVF project team met with President on Sept. 16 to validate NFP approach, key milestones and timelines to transition the BVF to a third party NFP – President endorsed proposed approach.
- BVF project team holding 3rd session on Sept. 21th focused on Expression of Interest process.
- 2nd business strategy session to be held between BVF and HHT teams by week of Sept. 21st to solidify value propositions for both facilities (BVF and CTMF).
- [REDACTED].
- Framework to be completed by mid-September to undertake e-scan, intelligence gathering and targeted stakeholder discussions on market uptake for running the BVF as an NFP.
- Next bi-weekly [REDACTED] meeting taking place on Sept 28; [REDACTED].
- Business Strategy:
- September update of the table listing vaccine platforms and alternative Canadian CMOs completed on Sept. 16th 2020.
For decision
- Engagement and approach to collaboration and tech-transfer [REDACTED] for BVF.
Project management and administration
Overall progress update
- Project Management:
- Project Charter and PCRA sign-offs completed by Sr Project Manager, M. Aubrey and CFO (D. Macmillan). President's sign-off on Project Charter week of Sept 21.
- Draft Project Management Plan to be reviewed by DG BVFP week of Sept 21.
- Consultant to support development of Master Project Plan will be onboarded the week of Sept 21st.
- Initial Risks/Issues Log and Decision Log have been created; capture of input from each lead is underway and will be collected/updated weekly.
For decision
- PCRA and Project Charter sign-offs week of Sept 14 – President sign-off on Project Charter week of Sept 21.
Project schedule (Appendix 1)
- Formal project schedule (August 10, 2020):
- Next on-site Construction Management Meeting with M. Aubrey, [REDACTED] and all contract leads (PSPC, [REDACTED]) took place Sept 17.
- Delivery dates for long-lead procurement items still within original targets.
- Construction back on track – construction crew continuing to work extra hours and Saturdays to make up time and still meet December timeline.
Upcoming decision
- [REDACTED].
Budget update (Appendix 2)
- No change
Pending decision
- Updated detailed budget variances, commitments and cashflow in progress.
- Updated document to be provided for approval before end of September
- BVF to present on overall project at IMC October 17th.
Annex A features 6 photos of the construction site for the new facility.
Appendix 1
| Project Milestone | Target End Date |
|---|---|
| 1. Formal Phase B – Project initiation | July 13, 2020 |
| 2. Design - Shell | Aug 31, 2020 |
| 3. Process Design | Sept 28, 2020 |
| 4. Interior Design | Nov 2, 2020 |
| 5. Shell Construction | Dec 15, 2020 |
| 6. Process Equipment (Long Lead) Procurement | August 31, 2020 |
| 7. Remaining Equipment Procurement | Sept 30, 2020 |
| 8. Clean Utilities Fabrication | Jan 11, 2021 |
| 9. Process Equipment Fabrication (Note 1) | March 31, 2021 |
| 10. Interior Fit-out | March 1, 2020 |
| 11. HVAC Installation | March 29, 2021 |
| 12. Clean Utilities Installation | March 29, 2021 |
| 13. Commissioning, Qualification, & GMP certification (Note 2) | July 31, 2021 |
Note 1) – Fabrication of long lead items:
- Bioreactors – 23 weeks (Aug 31, 2020 to Feb 1, 2021)
- Glasswasher – 32 weeks (Aug 31, 2020 to April 5, 2021)
- Decon Autoclave – 22 weeks (Aug 31, 2020 to January 25, 2021)
- Sterilization Autoclave – 32 weeks (Aug 31, 2020 to April 5, 2021
Note 2) – Bio-manufacturing facility is constructed and fully operational, and in process of regulatory approval and commissioning.
GMP certification is dependent on external expertise availability and subject to time bound performance - industry guidelines indicate 2‑5 months.
Appendix 2
| Current Total Project Cost | |||||
|---|---|---|---|---|---|
| Description of Project Costs | Source of Funding | ||||
| FY20‑21 | FY21‑22 | Future Years | TOTAL | ||
| Design & Engineering | Capital | $2,080,000 | $520,000 | $0 | $2,600,000 |
| Construction | Capital | $25,280,000 | $6,320,000 | $0 | $31,600,000 |
| Equipment & Automization | Capital | $22,400,000 | $5,600,000 | $0 | $28,000,000 |
| Validation & Commissioning | Capital | $800,000 | $200,000 | $0 | $1,000,000 |
| Building Contingency | Capital | $12,640,000 | $3,160,000 | $0 | $15,800,000 |
| Sub-Totals | $63,200,000 | $15,800,000 | $0 | $79,000,000 | |
| Prof. Services (please specify) | Capital | $800,000 | $0 | $0 | $800,000 |
| Project contingency | Capital | $16,000,000 | $4,200,000 | $0 | $20,200,000 |
| Sub-Totals | $16,800,000 | $4,200,000 | $0 | $21,000,000 | |
| Project Sub-Totals | $80,000,000 | $20,000,000 | $0 | $100,000,000 | |
| NRC Salary Capitalizable | Capital | $1,741,450 | $1,741,450 | $0 | $3,482,900 |
| Project Totals | $81,741,450 | $21,741,450 | $0 | $103,482,900 | |
| Total Project Cost (without Taxes) | |||||
Note: Salary Capitalizable of $3,482,900 is labour postings to project
Project contingency is controlled by the PM, Management Contingency is controlled by the Chair, IMC.
Appendix 2-A
2020‑08‑27 Revised Budget – given validation of process review, design and updated equipment requirements:
| Original cost | Total cost | Delta | Comments | |
|---|---|---|---|---|
| Direct costs – process equipment, qc laboratory equipment & automation | $27,975,000 | $28,940,000 | $965,000 | Equipment cost adjustment, Automation adjustment |
| Direct costs – mechanical & electrical | $10,072,000 | $12,834,000 | $2,762,000 | More mechanical services and large footprint |
| Direct costs – construction | $14,251,000 | $18,000,000 | $3,749,000 | Surface area increase from 49 900 sq.ft. To 57,850 sq.ft. |
| Sub-total direct cost | $52,298,000 | $59,774,000 | $7,476,000 | |
| General site conditions (Covid-19, assurances, trailer rental, toilets, fences, waste disposal, temporary services, etc.) (10%) | $3,215,000 | $3,545,910 | $330,910 | Cost adjustment due to construction cost increase |
| General contractor surintendant (8 months x 110$/hr) | $150,000 | $225,000 | $75,000 | Project schedule increased from 8 to 12 months |
| Contractor Management (management + administration + profits) (12%) | $3,876,000 | $3,203,297 | $672,703 | Cost adjustment of contractors CM Fees |
| Detailed design and site support – architecture, structure, civil, electrical, mechanical, clean utilities | $2,600,000 | $3,000,000 | $400,000 | To cover scope changes |
| Validation (facility, purified water, EMS, process equipment) & commissioning (clean utilities, mechanical) | $1,043,000 | $2,043,000 | $1,000,000 | Cost adjustment to reflect number of equipment to validate |
| Sub-total – indirect cost | $10,884,000 | $12,017,207 | $1,133,207 | |
| Sub-total – BMP biomanufacturing at NRC's facility (direct + indirect costs) | $63,182,000 | $71,791,207 | $8,609,207 | |
| Miscellaneous/unforeseen (25%) | $15,795,500 | $10,768,681 | -$5,026,819 | Contingency reduced to 15% |
| Total – GMP biomanufacturing at NRC's facility | $78,977,500 | $82,559,888 | $3,582,388 |