microvolume ultrasensitive flow cytometer

Advance Contract Award Notice (ACAN)

[23-58273]

[microvolume
ultrasensitive flow cytometer]

1. Advance Contract Award Notice (ACAN)

An ACAN is a public notice indicating to the supplier community that a department or agency intends to award a contract for goods, services or construction to a pre-identified supplier, thereby allowing other suppliers to signal their interest in bidding, by submitting a statement of capabilities. If no supplier submits a statement of capabilities that meets the requirements set out in the ACAN, on or before the closing date stated in the ACAN, the contracting officer may then proceed with the award to the pre-identified supplier.
2. Definition of the requirement
Human Health Therapeutics (HHT), a Research Center within the National Research Council of Canada has a requirement for an ultra sensitive micro-volume flow cytometer to conduct a variety of research in the fields of Human Health Therapeutics related to viral vectors for gene therapy, Virus-like-particles for vaccines and other large therapeutic biological molecules.
3. Criteria for assessment of the Statement of Capabilities (Minimum Essential Requirements)
The National Research Council Canada has a requirement for an microvolume ultrasensitive flow cytometer. The requirement must include all of the following:
(a) Scatter sensitivity (size and concentration measurement) with a dynamic range of 40nm-1μm
(b) Fluorescence sensitivity to measure particles < 20nm
(c) Real-time, individual particle trace event to remove risk of swarm-detection
(d) Minimum sample requirement of 10 µL
(e) Scatter-triggering of signal detection to ensure no risk of false-positive events compared to fluorescence triggering detection.
(f) Single particle simultaneous measurement of size, concentration and fluorescent intensity for fluorescently labelled samples
(g) The Contractor must provide installation, training, manuals and maintenance and support services;
(h) Optional Extended Warranty
Section (a) – Technical Requirements for the viscometer system
(1) The flow cytometer system must conform to the following technical requirements:
1. Scatter sensitivity (size and concentration measurement) with a dynamic range of 40nm-1μm
2. Fluorescence sensitivity to measure particles < 20nm
3. Real-time, individual particle trace event to remove risk of swarm-detection
4. Minimum sample requirement of 10 µL
5. Scatter-triggering of signal detection to ensure no risk of false-positive events compared to fluorescence triggering detection.
6. Single particle simultaneous measurement of size, concentration and fluorescent intensity for fluorescently labelled samples
(2) Power supply Requirements:
1. 100-240V AC;
2. 50-60Hz;
(3) The Contractor must meet all applicable Canadian Standard Association (CSA) or Underwriters' Laboratories of Canada (ULC) standards;
Section (b) – Software Requirements:
1. The software must control the instrument for acquisition of data
2. The software must be capable of data processing including determining peak height, area and width for all channels
3. The software must be capable of data export to excel or csv compatible format;
4. The software must be capable of producing reports in PDF format;

Section (c) – Installation:
The Contractor must deliver, install, integrate, and configure all deliverables at the location specified in the Contract.
The Contractor must unpack, assemble, and install the deliverables at the site. If applicable, this includes but is not limited to the provision of required moving and installation resources, packing material, vehicles, cranes, personnel, and floor protection panels.
The Contractor must supply all associated materials required to effect complete installation, integration and configuration of the deliverables at the site. This must include but not be limited to such things as all the required power connectors, cables, and any other accessories required to install, integrate and configure the deliverables.
Upon successful completion of the installation, integration and configuration of the deliverables, the Contractor must provide the Technical Authority with written notification that the deliverables are ready for testing.
The Contractor must maintain all work areas at the installation site(s) in a clean and tidy condition on completion of each day’s work and on completion of acceptance, including the removal and disposal of all related packing material.
The Contractor must begin installation within fourteen calendar days of delivery and must complete the installation within two calendar days from the installation start date.
Section (d) - Manuals
The Contractor must deliver 1 complete set of Documentation, in English and French with the deliverables.
This documentation must include all publications pertaining to technical specifications, installation requirements and operating instructions.
Section (e) - Training
The Contractor must provide remote online or onsite training to the Client in English (and French if required by the client) for the following audience:
End User (up to 5): Training must include operation and manipulation of the equipment and data analysis software. The training should include but not be limited to product functionality, product features and limitations.
The Contractor must deliver the training within 10 calendar days of installation.
4. Applicability of the trade agreement(s) to the procurement

This procurement is subject to the following trade agreement(s)
o Canadian Free Trade Agreement (CFTA)
o Revised World Trade Organization - Agreement on Government Procurement (WTO-AGP)
o Canada-European Union Comprehensive Economic and Trade Agreement (CETA)
o Comprehensive and Progressive Agreement for Trans-Pacific Partnership (CPTPP)
o Canada-Chile Free Trade Agreement (CCFTA)
o Canada-Colombia Free Trade Agreement
o Canada-Honduras Free Trade Agreement
o Canada-Korea Free Trade Agreement
o Canada-Panama Free Trade Agreement
o Canada-Peru Free Trade Agreement (CPFTA)
o Canada-United Kingdom Trade Continuity Agreement (Canada-UK TCA)
o Canada-Ukraine Free Trade Agreement (CUFTA)
7. Justification for the Pre-Identified Supplier
No, there are no alternative sources of supply for the same or equivalent material/support. Flow Cytometry manufacturers claiming to be able to measure particles in a similar size range as the NanoAnalyzer include Luminex, Beckman Coulter and Apogee Flow. Unlike the NanoAnalyzer which uses particle scatter to trigger detection, these other devices trigger detection based on the presence of a detectable amount of fluorescence, which leads to a bias towards higher sized particles and requires appropriate labelling. This labeling is something that will not be possible with some of the samples we are being asked to characterize. Furthermore, this approach leads to the confusion between signal and contamination, as antibody aggregates can generate large fluorescence signals. Finally, these devices establish their scatter sensitivity based on polystyrene beads, which have a significantly higher refractive index than both biological particles and silica. This means the actual maximum sensitivity for these devices for the biological particles we will be measuring is closer to 200nm, rather than the unique 40nm lower size limit capable with the NanoAnalyzer.
In summary, although there is one other suppliers of flow cytometers, no alternative sources of supply can provide the same or equivalent capabilities. In particular, the NanoFCM Nanoanalyzer from is the only system with the following required capabilities:
1) Scatter sensitivity (size and concentration measurement) with a dynamic range of 40nm-1μm
2) Fluorescence sensitivity to measure particles < 20nm
3) Real-time, individual particle trace event to remove risk of swarm-detection
4) Minimum sample requirement of 10 uL
5) Scatter-triggering of signal detection to ensure no risk of false-positive events compared to fluorescence triggering detection.
6) Single particle simultaneous measurement of size, concentration and fluorescent intensity for fluorescently labelled samples
8. Government Contracts Regulations Exception(s)
The following exception to the Government Contracts Regulations is invoked for this procurement under subsection 6(d) - "only one person is capable of performing the contract".
9. Exclusions and/or Limited Tendering Reasons

The following exclusion(s) and/or limited tendering reasons are invoked under the:
a. Canadian Free Trade Agreement (CFTA) – Article 513 (1) (b) (iii): due to an absence of competition for technical reasons;
b. World Trade Organization - Agreement on Government Procurement (WTO-AGP) – Article XIII (b) (iii): due to an absence of competition for technical reasons;
c. Canada-European Union Comprehensive Economic and Trade Agreement (CETA) – Article 19.12 (b) (iii): due to an absence of competition for technical reasons;
d. Comprehensive and Progressive Agreement for Trans-Pacific Partnership (CPTPP) – Article 15.10 (2) (b) (iii): due to an absence of competition for technical reasons;
e. Canada-Chile Free Trade Agreement (CCFTA) – Article Kbis-16 (2) (c): necessary to protect intellectual property;
f. Canada-Colombia Free Trade Agreement – Article 1409 (1) (b) (iii): due to an absence of competition for technical reasons;
g. Canada-Honduras Free Trade Agreement – Article 17.11 (2) (b) (iii): due to an absence of competition for technical reasons;
h. Canada-Korea Free Trade Agreement – referencing the WTO Protocol Amending the GPA, Article XIII (1) (b) (iii): due to an absence of competition for technical reasons;
i. Canada-Panama Free Trade Agreement – Article 16.10 (1) (b) (iii): because of the absence of competition for technical reasons;
j. Canada-Peru Free Trade Agreement (CPFTA) –Article 1409 (1) (b) (iii): due to an absence of competition for technical reasons;
k. Canada-Ukraine Free Trade Agreement (CUFTA) – Annex 10-6 (2) (a): any form of preference, including set asides, to benefit micro, small and medium enterprises; and
l. Canada-United Kingdom Trade Continuity Agreement: refer to CETA as the provisions of CETA are incorporated by reference into and made part of this Agreement. (CETA) Article 19.12 (b) (iii).
10. Period of the proposed contract or delivery date

The equipment must be delivered by May 1st 2024.
13. Name and address of the pre-identified supplier
NanoFCM Inc.
Floor 11, Building No.5, Xinke Square, Xiamen,
361006, CHINA
14. Suppliers' right to submit a statement of capabilities

Suppliers who consider themselves fully qualified and available to provide the goods, services or construction services described in the ACAN may submit a statement of capabilities in writing to the contact person identified in this notice on or before the closing date of this notice. The statement of capabilities must clearly demonstrate how the supplier meets the advertised requirements.
15. Closing date for a submission of a statement of capabilities
The closing date and time for accepting statements of capabilities is June 1th, 2024 at 2:00 pm EDT.
16. Inquiries and submission of statements of capabilities
Name : Jonathan Soles
Title: Contracting Authority
Telephone: 343-548-9258
Email : Jonathan.Soles@nrc-cnrc.gc.ca