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 2R2
    Canada
    Contracting authority
    Cindy Romain
    Phone
    (613) 299-2748
    Email
    cindy.romain@nrc-cnrc.gc.ca
    Address

    1200 Montreal Rd M58

    ottawa, ON, K1A 0R6
    Canada
    Bidding details
    Full details regarding this tender opportunity are available in the documents below. Click on the document name to download the file. Contact the contracting officer if you have any questions regarding these documents. Access the Getting started page for details on how to bid, and more.

    Summary information

    Notice type
    Request for Proposal
    Language(s)
    English, French
    Region(s) of delivery
    Canada
    Region of opportunity
    Canada
    Contract duration
    2 month(s)
    Procurement method
    Competitive – Open Bidding
    Selection criteria
    Highest Combined Rating of Technical Merit and Price