Advance Contract Award Notice (ACAN)
[23-58186]
[Chromatography System]
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
The Human Health Therapeutics (HHT) portfolio of the National Research Council Canada (NRC) plans to expand their capacity for purification processes development. In order to meet the increasing demand of the Canadian biopharmaceutical industry for rapid process development for recombinant proteins, Viruses and Virus like particles and tech transfer to Contract Manufacturing Organizations (CMOs). Within this mandate, NRC wishes to purchase new chromatography system.
The work consists of supply, delivery, system installation at NRC Montreal site, training on equipment use; all of the work must be completed by March 31, 2024.
3. Criteria for assessment of the Statement of Capabilities (Minimum Essential Requirements)
Mandatory technical specifications
The delivered equipment must have the following specifications:
The Chromatography systems must;
3.1 Be of modular design allowing user to add/remove different valves with a flexibility to place them based on the planned experiment requirements.
3.2 Must have two metering type piston pumps for buffers with following flow rate capacity,
3.2.1 System pump: 0.001 to 25 ml/min (.0.01 to 50 ml/min in column packing flow)
3.3 Must have one metering type piston pump for sample loading with following flow rate capacity,
3.3.1 Sample pump: 0.001 to 25 ml/min
3.4 Must have following pressure range.
3.4.1 System: 0 to 20 MPa
3.5 Have two buffer valves and one sample valve with minimum 7 inlets each and built in air sensors to avoid air being pumped onto the column.
3.6 Have a column valve with 5 column ports and pre and post column pressure detectors to be able to calculate delta P (pressure across the column bed).
3.7 Have multi-wavelength UV detector (190 to 700 nanometer), monitor three simultaneous wavelength and must use the Xenon flash lamp (does not generate heat).
3.8 Have pH valve with integrated pH electrode with a pH reading range of 1-14.
3.9 Have conductivity monitor with integrated temperature sensor to correct the variation in conductivity due to temperature variations with reading range of 0.01-999 mS/cm.
3.9 Have fraction collector with no spill feature at high flow collection to prevent contamination or a possible loss of sample due to spill. It must have a closed design to protect fractions from dust and other free particles.
3.10 Include all required software to operate the systems and compatible with Windows 10 or higher.
3.11 Include DoE module (Design of Experiment) with operating software to enable user design experiments for scouting parameters like flow velocity, sample/buffer pH, ionic strength, chromatography media etc., create methods and runs them. The module must analyze the DoE results to provide and able to generate graphical data representation.
4.0 Deliverables:
4.1 The chromatography system must be delivered with operating instructions in either English or French, user guide and instrument configuration.
4.2 The supplier must install the system at delivery address, perform the installation test and provide the report.
4.3 The supplier must include onsite training of at least two persons in either English or French.
5.0 Delivery and Installation
The system must be delivered and installed at 6100, Royalmount Avenue, Montréal, Québec, H4P 2R2.
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)
5. Justification for the Pre-Identified Supplier
The pre-identified supplier is Global Life Sciences Solutions. Due to commonality and compatibility with existing equipment, the preidentified supplier, Global Life Sciences Solutions Canada ULC, is the only one able to distribute Cytiva equipment in Canada.
NRC’ s HHT research center already owns multiple ÄKTA chromatography systems. The system to be purchased must also be an ÄKTA for reason of interoperability with existing systems and software. The AKTApure 25M manufactured by Cytiva meet all the requirements and are fully compatible with existing systems and will integrate seamlessly into our production-like environment, thus allowing for repeatability of processes, column packing processes and commonality of the Operating System (O/S), parts and hardware configurations, interchangeability and data transfer.
HHT develops the purification process/technology and transfers them to Contract Manufacturing Organizations (CMO) for GMP productions. Biologics Manufacturing Center (BMC) and Clinical Trial Manufacturing Facility (CTMF) will act as future CMOs and they have manufacturing scale AKTA chromatography system (AKTA ready gradient) so by having the same system AKTA series of chromatography systems in both R&D team and NRC manufacturing team (CTMF) make purification process transfer seamless and reduces the risk of process failure at manufacturing scale.
Cytiva is also the owner of the UnicornTM software. The UnicornTM software allows users to design chromatography steps based on parameters defined by the user and to automatically create methods and execute them with the system. The software has the programmed phases that can be quickly drag and drop to create a purification method for automated runs in daily operations. The software also enables programming with flow velocity in column volumes per hour (CV/h) and normalization of UV signal. This possibility makes scaling and transfer of methods as well as data comparison easier.
The UnicornTM software also comes with a DoE module which help designing the experiment in such a way that multiple parameters can be screen in relatively small no of experiments that eventually save time and material.
6. 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".
7. 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).
8. Period of the proposed contract or delivery date
The equipment must be delivered by March 29th 2024.
9. Name and address of the pre-identified supplier
GLOBAL LIFE SCIENCES SOLUTIONS : 1400C-250 HOWE STREET, V6C 3S7, VANCOUVER, Canada
10. 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.
11. Closing date for a submission of a statement of capabilities
The closing date and time for accepting statements of capabilities is January 3rd, 2024 at 2:00 pm EDT.
12. Inquiries and submission of statements of capabilities
Name : Jonathan Soles
Title: Contracting Authority
Telephone: 343-548-9258
Email : Jonathan.Soles@nrc-cnrc.gc.ca
