25-58084 - Feasibility Study for Fill / Finish, Cryo-storage and Packaging room construction and qualification for a new Clinical Trial Manufacturing Facility (CTMF) (Канада - Тендер #67448691)

Basic Information

Reference Number

cb-482-27088513

Issuing Organization

National Research Council of Canada (NRC)

Solicitation Type

RFP - Request for Proposal (Formal)

Solicitation Number

25-58084

Title

Feasibility Study for Fill / Finish, Cryo-storage and Packaging room construction and qualification for a new Clinical Trial Manufacturing Facility (CTMF)

Source ID

PWGSC

Agreement Type

Canada-Korea Free Trade Agreement

Details

Location

Canada

Dates

Publication

2025/10/01 12:00:00 AM EDT

Closing Date

2025/10/27 02:00:00 PM EDT

Contact Information

Cindy Romain

(613) 299-2748

cindy.romain@nrc-cnrc.gc.ca

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.

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