This Solicitation opportunity from Government of Canada was posted on January 9, 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 Utilities and Ventilation Risk - Clinical Trial Material Facility

Closed

24-58190International

Submission Closed01/09/2025, 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 Canada is seeking a feasibility study for utilities and ventilation risk mitigation services for its new Clinical Trial Manufacturing Facility in Montreal, Quebec. This facility is designed for the production and quality control of biologics, including protein, viral vector, and virus-like particle vaccines, and must adhere to strict Canadian GMP, FDA cGMP, and Eudralex regulatory standards. The project involves classified grade C and D areas encompassing viral seed stock preparation, cell culture, viral production, purification, and warehousing. As the facility prepares to onboard clients and begin GMP production runs, it has encountered specific challenges regarding its utilities and ventilation systems that require professional assessment and mitigation. This solicitation, numbered 24-58190, aims to address these infrastructure risks to ensure the facility can operate reliably under normal environmental conditions and its existing power supply.

General Info

Feasibility study for utilities and ventilation risk mitigation at Montreal biologics manufacturing facility.

Agency

Government of Canada → National Research Council Canada

NAICS

541330 - Engineering Services

Place of Performance

*World, CAN

Set-Aside

NONE

Documents

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Timeline

PhaseClosed

PostedJan 9

Solicitation

Response DeadlineJan 9

Deadline has passed

Submission Closed

01/09/2025, 02:00:00 PM UTC

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Organization & Contact Information

AgencyGovernment of Canada → National Research Council Canada

Contacts1 person available

OfficeN/A

Organization / Agency

Government of Canada → National Research Council Canada

Office AddressN/A

Contacts

Cindy RomainPoint of Contact

contact@example.gov

+1 (555) 000-0000

Full Description

Feasibility Study for Utilities and Ventilation Risk Mitigation Services for a new Clinical Trial Manufacturing Facility . The National Research Council of Canada is building a new Clinical Trial Manufacturing Facility (CTMF) that will house the process and equipment for the production and the quality control of protein, viral vector or virus-like particle vaccines or biologics. The products are mainly intended for the Canadian market, regulated by Health Canada under the authority of the Food and Drugs Act. The facility will require being compliant with Canadian Good Manufacturing Practices (GMP) as well as FDA current GMP (cGMP) and Eudralex requirements. The new manufacturing rooms and airlocks (personnel and material) will be built in an extension to the existing NRC’s premises located in Montreal, Quebec and will consist of classified grade C and D areas. The facility will include equipment and infrastructures necessary for viral seed stock preparation, subculture, cell culture and viral production, purification and warehousing. The facility was designed to operate under normal environmental condition and Hydro-Quebec power supply. As CTMF is ramping towards onboarding a client and initiate GMP production runs, several challenges have emerged impacting our utilities and ventilation.