automated multi- parallel bioreactor system

Advanced Contract Award Notice (ACAN)

24-58001/A

multi- parallel bioreactor 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 National Research Council (NRC) of Canada has a requirement for the supply of an 8-units multi-parallel bioreactor system for cell culture. This system will be used for high-throughput upstream process development of cell culture-based bioprocess for the manufacturing, of monoclonal antibodies, recombinant protein, viral vector, vaccines, viruses and virus-like-particle and cell and gene therapy. The system needs to operate both glass bioreactor vessels, and fully bioreactor single-use vessels. The system to be purchased comprise of bioreactor controllers with all required all cables, probes and accessories to meet the criteria listed in Section 3, 8 glass vessels of 0.35-1L working volume, and one operator interface or Human-Machine Interface (HMI) interfaced with all eight bioreactors for the use of the operator to set up the bioreactor parameters setpoint, control strategy and trending. It will be used in the Human Health Therapeutics Research Center Bioprocess facility by the Cell Culture Scale-Up Team at its Royalmount facility in Montreal.

3. Criteria for assessment of the Statement of Capabilities (Minimum Mandatory Requirements):

Any interested supplier must demonstrate by way of a statement of capabilities that its system meets the following mandatory technical requirements:
Space constraints:
The system, including the bioreactor controller, the vessels themselves, the control screen must fit into a 72” x 32” benchspace (width x depth) inside a BSL-II biosafety cabinet, with a maximum height of 81”.

Mandatory technical requirements:

1. Bioreactor vessels: The bioreactor controller must have the capacity to operate either autoclavable glass, or fully single-use bioreactors of a working volume comprised between 0.35L and 1L. The system must be able to support up to 8 bioreactors in parallel.
a. The single-vessels should be sterile and the material in contact should not interfere with cell growth and should not be present in the product of interest after purification (no leachable / extractable compounds).
b. The single-use vessels must be fully single-use, i.e. no requirement for additional autoclavable pH and dissolved oxygen probes to be added.
c. The glass vessels must have a second impeller as an option.
d. Both the single-use and the glass vessels must be equipped with either pitched blade impeller or elephant ear impeller designed for cell culture
e. For both the single-use vessel and the glass vessel, the aspect ratio for the impeller (impeller diameter: inner vessel diameter ratio) must be greater than 1:3 (impeller:vessel) but smaller than 1:2
f. The bioreactor vessels must be equipped with a frit sparger or microsparger with pore size no greater than 50 µm.
g. A second sparger must be included as an option instead of the microsparger. It has to be a macrosparger or drilled-hole sparger, with a pore size of 0.5 mm or greater.
h. The aspect ratio of the vessel (Total vessel inner height: vessel inner diameter) ratio must be equal to our larger scale vessels, with a ratio of approximatively 2:1 height/diameter ratio, or 1.5:1 height to diameter ratio using the height at maximum working volume instead of the inner height of the vessel
2. Bioreactor vessel top plate: The top plate on the glass vessels must have enough PG13.5 / 12 mm ports to accommodate, at least:
a. One pH probe (12 mm port Diameter, PG13.5)
b. One DO probe (12 mm port Diameter, PG13.5)
c. One exhaust (condenser) port
d. One feed addition line (between 1 and 3.2 mm inner diameter)
e. One transfer line for cell culture medium (minimum inner diameter of 2.0 mm)
f. One base addition line (between 1 and 3.2 mm inner diameter)
g. One sampling line (between 1 and 3.2 mm, with a dip tube reaching into the vessel)
h. One overlay gassing inlet (between 1 and 3.2 mm)
i. One sparger gassing inlet
j. One harvest line, with a dip tube reaching the bottom of the vessel (minimum inner diameter between 1 and 3.2 mm)
k. One extra port for inoculation via gravity (minimum 2.0 mm inner diameter)
3. Agitation rate:
a. The minimum speed of the impeller must be equal or lower than 100 RPM.
b. The maximum speed must be equal or higher than 400 RPM.
4. Temperature control
a. The bioreactor must be able to measure and control the temperature inside the vessel between 10 and 39 oC, with a precision of +/- 0.2 oC at 37 oC.
b. The temperature control unit must allow for heating and cooling of the vessel at full working volume: heating from 4 to 37 oC within 4 hours (at least 0.5 kW) and cooling (using external cooling water) from 37 oC to 30 oC within 4 hours.
c. The exhaust filter of the bioreactor must be heated via a heating blanket adapted to exhaust filters, or cooled down using a condenser to prevent filter clogging due to condensation.
5. Dissolved Oxygen control
a. The dissolved oxygen must be controllable between no less than 5% (minimum value) and at least 100% air saturation (maximum), with a precision of +/- 5% at a 40% air saturation setpoint
b. Dissolved oxygen level must be controlled by a combination of oxygen, air and nitrogen via sparging. The strategy must be customizable by the operator or the NRC technical staff with respect to flow rates and gas composition
6. pH control: pH level must be controllable between 3 and 10 +/- 0.05, using CO2 flow rate and base addition via pump
7. Pumping:
a. At least 2 peristaltic pumps must be included with the bioreactor, with all pumps able to accommodate tubing with inner diameter of up to 2 mm
b. One variable speed pump must be dedicated to base addition for pH control, with maximal flow greater than 0.6 mL/min using silicone or pharmed tubing
c. One variable speed pump must be dedicated to feed, or culture media inlet addition. This pump must, using silicone or pharmed tubing, have a minimal flow rate no greater than 0.1 mL/min, and a maximum flow rate no less than 2 mL/min.
8. Gassing
a. All gas flow rates must be measurable and controllable via Mass Flow Controllers (MFC), with a precision of at least 1% at Full Scale
b. The gas flow rate must include at least one air flow rate for the overlay, with a minimum of no more than 20 mL/min (0.02 vvm at maximum working volume), and a maximum of no less than 200 mL/min (0.2 vvm at full working volume))
c. The gas flow rate must include 4 MFCs for the spargers. The flow rate of each mass flow must have a minimum of no more than 2 ml/min - and and a maximum flow rate greater or equal to 50 mL/min (0.050 vvm at full working volume). The required gasses are: CO2, air, O2, and nitrogen
9. Operator Interface
The system must have only one operator interface to control all eight vessels. This interface is to be used to assign setpoint, control loops and control strategies, probe calibration and to be able to look at the key parameters’ trends.
10. Trending
a. Trending must be available for the different key parameters in real-time: temperature, Dissolved oxygen, pH, etc. It must be possible using only a single control screen or HMI for all 8 bioreactors. It must be possible to overlay the trends for the different parameters (ex: temperature) for all 8 vessels on the same trend graph
11. Communication: The system must be compatible with OPC (Open Platform Communications) UA/DA communication
12. Applicable standards: The Contractor must meet all applicable Canadian Standard Association (CSA) or Underwriters' Laboratories of Canada (ULC) standards

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:
Eppendorf is the Original Equipment Manufacturer. They are the owners, developers of the equipment and owners of the IP. They do not authorize value-added resellers or distributors for their equipment. Eppendorf is the sole distributor of its DASGIP bioreactor system for cell culture.

Eppendorf has been selected for this procurement as there are no other sources of supply that satisfy NRC’s requirement for this purchase. No other supplier could be identified that can provide an 8-parallel bioreactor system of the intended scale (0.35 – 1L), that can operate both fully single-use (i.e. no need for sterilizable probe for pH and Dissolved oxygen control) as well as glass vessels, and that can fit within the space constraints of our Biosafety containment level 2 laboratory: 72 inches width, 32 inches depth and 81 inches eight. All these constraints are essential, since it will allow the operation of this system in the NRC’s current laboratories, under a segregated space to prevent biosafety issue, and the use of either single-use or glass vessels will allow this equipment to support both client-focused project, as well as internal and academic research projects.

6. Exclusions and/or Limited Tendering Reasons:

Only one vendor is able to meet the unique technical requirements listed herein.
The following exception to the Government Contracts Regulations is invoked for this procurement under subsection 6 (d) as only one supplier is capable of performing work.

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 XIII (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. Ownership of Intellectual Property:

The Crown will have the right of use for normal business operations of the system once purchased. The design and system’s intellectual property are solely owned by the contractor.

All IP generated on this instrument during its use by would belong entirely to NRC and its Research partners.

9. Period of the proposed contract or delivery date:

NRC is expecting the equipment to be delivered within 4 months, based on the date of the contract.

10. Name and address of the pre-identified supplier:

Eppendorf North America
2810 Argentia Road, #2
Mississauga, Ontario L5N 8L2 Canada

11. 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, within 15 days, 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 each of the advertised requirements in Section 3.

12. Closing date for a submission of a statement of capabilities:

The closing date and time for accepting statements of capabilities is June 7th , 2024 at 2:00PM EST.

13. Inquiries and statements of capabilities are to be directed to:

Paul Hewitt
National Research Council Canada
Procurement specialist
Email: Paul.Hewitt@nrc-cnrc.gc.ca