Feasibility Study for Fill / Finish, Cryo-storage and Packaging room construction and qualification for a new Clinical Trial Manufacturing Facility (CTMF)
Solicitation number 25-58084
Publication date
Closing date and time 2025/11/03 14:00 EST
Last amendment date
Description
Fill and Finish Process
The objectives of the feasibility study are to determine the cost and timeline to design, build and qualify a cleanroom for fill finish. The room will host a modular filling and lyophilization line to fill and freeze dry. In addition, the room will include a single door autoclave to sterilize re-usable components. The room will be designed to meet class C.
Secondary Packaging Process
The objectives of the feasibility study are to determine the cost and timeline to design, build and qualify a packaging hall to perform particle inspection, to detect glass integrity and secondary packaging (labeling, cartoning, bundling, check weighing, case packing and palletizing). The room will host an inspection machine and a modular packaging line. The room will be designed to meet CNC.
Cryo-storage
The objectives of the feasibility study are to determine the cost and timeline to design, build and qualify a storage room to host 4 freezers, 4 cryo-freezers and 1 refrigerator. The room will be designed to supply nitrogen for the cryo-freeze and a miniature warehouse racking. The room is designed to be NC.
Network Infrastructure
The objectives of the feasibility study are to determine the cost and timeline to design, build and qualify a new program application and infrastructure to the existing infrastructure. The infrastructure will include integration of NAV ERP, LIMS, MES, QMS, MIT, GS1, CPM, EMS, IMS and DBMS.
Contract duration
The estimated contract period will be 2 month(s), with a proposed start date of 2025/11/12.
Trade agreements
-
Canada-Korea Free Trade Agreement (CKFTA)
Reason for limited tendering
A contracting officer can use limited tendering for specific reasons outlined in the applicable trade agreements. The reason for this contract is described below:
-
None
Businesses interested in partnering for this tender opportunity:
Note: Information may not be available in both English and French. This is because the Official Languages Act does not apply.
Contact information
Contracting organization
- Organization
-
National Research Council of Canada (NRC)
- Address
-
6100 Royalmount Ave Gate 10
Montreal, Quebec, H4P 2R2Canada
- Contracting authority
- Cindy Romain
- Phone
- (613) 299-2748
- Email
- cindy.romain@nrc-cnrc.gc.ca
- Address
-
1200 Montreal Rd M58
ottawa, ON, K1A 0R6Canada
Bidding details
| Document title | Amendment no. | Language | Unique downloads | Date added |
|---|---|---|---|---|
| Amendment_1_RFP_ 25-58084_EN_FR.pdf | 001 | EN and FR | 14 | 2025/10/21 |
| ENGLISH_RFP-25-58084_Feasability_Study_Fill_and_Finish_Area_29_Sept_Annexed_01_oct_CR.pdf | 001 | EN | 45 | 2025/10/01 |
| NPP_RFP_25-58084_EN_FR_01_oct__1.pdf | 001 | EN and FR | 46 | 2025/10/01 |
| FRENCH_RFP_25-58084_Feasibility_Studu_Fill_and_Finish_01_Annexed_oct_01_cr_0.pdf | 001 | FR | 29 | 2025/10/01 |