This Solicitation opportunity from Government of Canada was posted on November 3, 2025. The submission period has ended. Browse the details below for market research, or find similar active opportunities.

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

Closed

25-58084International

Submission Closed11/03/2025, 02:00:00 PM UTC

Contract Overview

Solicitation details, issuing organization, response deadlines, documents, and interested companies for this government contract opportunity.

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AI Contract Overview

The National Research Council of Canada has issued solicitation 25-58084 for a feasibility study to determine the costs and timelines associated with the design, construction, and qualification of a new Clinical Trial Manufacturing Facility. The project encompasses three primary physical areas: a Class C cleanroom for fill and finish operations featuring a modular filling and lyophilization line with a single door autoclave, a CNC packaging hall for particle inspection and secondary packaging, and an NC storage room equipped for cryo-freezers, refrigerators, and nitrogen supply. Additionally, the study covers the development of network infrastructure to integrate a new program application with existing systems. This digital integration includes a wide array of management and data systems such as NAV ERP, LIMS, MES, QMS, and DBMS. The overall goal is to establish a comprehensive operational framework for the facility's manufacturing, storage, and data management capabilities.

General Info

Feasibility study for NRC Clinical Trial Manufacturing Facility costs, timelines, and digital integration.

Agency

Government of Canada → National Research Council of Canada

NAICS

541330 - Engineering Services

Place of Performance

*Canada, CAN

Set-Aside

NONE

Documents

No documents available

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Timeline

PhaseClosed

PostedNov 3

Solicitation

Response DeadlineNov 3

Deadline has passed

Submission Closed

11/03/2025, 02:00:00 PM UTC

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Organization & Contact Information

AgencyGovernment of Canada → National Research Council of Canada

Contacts1 person available

OfficeN/A

Organization / AgencyGovernment of Canada → National Research Council of Canada

Office AddressN/A

Contacts

Cindy RomainPoint of Contact

contact@example.gov

+1 (555) 000-0000

Full 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.