Final SOR Instrument Mini Parallel Bioreactor.pdf

STATEMENT OF REQUIREMENTS

TITLE: Procurement of a Modular, Parallel Mini Bioreactor System

I. BACKGROUND INFORMATION

BBD needs laboratory-scale mammalian cell culture “upstream” biomanufacturing capabilities at the mini-bioreactor scale (approximately 200 mL working volume) that perform multiple discrete cultures and/or upstream processes in parallel and incorporate single-use consumables into combined units, including the bioreactor, feed reservoirs, wetted pump components, and process analytical technology (PAT). BBD has determined that the brand name Ambr250

Modular Bioreactor uniquely meets this need.

II. SPECIFICATIONS

The Contractor shall provide one (1) Parallel Mini Bioreactor System that meets the following minimum specifications. Options to extend the instrument warranty beyond one year must also be provided.

System Requirements:

1. The bioreactor system shall include one (1) integrated PC-based controller and sufficient modules and components to support four (4) simultaneous, parallel mammalian cell cultures of at least 150 mL working volume each, with capabilities to maintain independent control parameter setpoints (including temperature, agitation, gas flow volume, and gas flow mixture), monitor independent process analytical technologies (PATs), and control independent additions via reservoirs and pumps.

2. The bioreactor system shall be configured to be compatible with potential future field-installed expansion with respect to the number of culture vessels such that at least eight (≥8) culture vessels can be controlled independently and simultaneously by the single, integrated PC-based controller.

3. The bioreactor system shall include hardware to support PAT measurement of pH and dissolved oxygen independently for each parallel culture vessel.

4. The bioreactor system shall include hardware to mix, by automated mass flow controller, and supply to each culture vessel air, oxygen, and carbon dioxide gasses both via submersed sparger and via headspace overlay.

5. The bioreactor system shall include hardware and capabilities for independent, simultaneous sensing of culture foaming for each vessel.

6. The bioreactor system shall provide cooling and/or refrigeration to ≤10 °C for at least one additional reservoir per culture vessel.

7. The Contractor shall supply the minimum quantity of hardware-specific consumables required by the original equipment manufacturer (OEM) to perform installation, demonstration of specifications, and training of the bioreactor system.

8. The Contractor shall provide one set of copies of all documentation and manuals for instrument conformity and initial calibration as delivered and for end-user instrument operation and maintenance, in either hard copy or electronic format.

9. The Contractor shall deliver one (1) license for software for designing and planning statistical

Design of Experiments (DoE) experiments to be performed with the bioreactor system with capabilities including run order and run group planning and automated programming of control parameter setpoint ranges across the experiment set. The license shall be compatible with installation on a NIST-provided Windows-based personal computer.

Installation:

The Contractor shall install the instrument in Building 227, Room A220, at NIST Gaithersburg, MD. Installation shall include, at a minimum, uncrating/unpacking of all equipment, set-up, and hook-up of all equipment, start-up, demonstration of specifications, and removal of all trash. The instrument must operate to the manufacturer’s specifications upon installation. Installation shall take place during normal business hours, between 8:30 am and 5:00 pm Eastern Time, Monday through Friday, except for Federal Holidays, and will be coordinated with the NIST Contract

Officer Representative (COR) and Subject Matter Expert (SME). Installation shall occur within

30 calendar days of delivery.

Warranty:

Base award: The contractor shall provide, at a minimum, a one-year warranty for the equipment.

The warranty shall cover all parts, labor, and travel. The warranty shall commence upon acceptance of the system by the Government.

Options for Warranty Extension

• The Contractor shall include options for the extended warranty of the system in one (1) -year increments for up to an additional four (4) years.

• The extended warranty should include the following:

o One (1) annual preventative maintenance visit, inclusive of travel, labor, wear parts, software updates and instrument performance verification.

Unlimited visits for instrument failure and repair, inclusive of travel, labor, replacement parts, instrument performance verification and remote/help-desk support.

Training:

The contractor shall include training at NIST for up to four (4) NIST personnel on normal operation, troubleshooting, and routine maintenance. Training shall be provided during normal business hours, between 8:30 a.m. and 5:00 p.m. Eastern Time, Monday through Friday, except

Federal Holidays, and coordinated with the NIST COR and SME to ensure maximum availability of NIST personnel. Training is to occur within 10 business days of installation. The training may be completed on-site at NIST immediately after installation and demonstration of specifications.

III. DELIVERABLES

All deliveries will be made to the following address:

National Institute of Standards and Technology

100 Bureau Drive

Building 227, Room A220

Gaithersburg, MD 20899

Delivery shall occur during normal business hours, between 8:30 am and 5:00 pm Eastern Time, Monday through Friday, except Federal Holidays, and shall be coordinated with the NIST COR and SME.

Description Quantity Recipient Method of Delivery Due Date

Bioreactor System including consumables

One (1) COR Shipped to NIST 120 calendar days after award

Copies of documentation and user manuals (hard copy or electronic format)

One (1) set

COR Shipped to NIST or

Electronic

120 calendar days after award

DoE Software License One (1) COR Electronic 120 calendar days after award

Installation Once COR On-Site Installation 30 calendar days after delivery

Training of NIST personnel at NIST, Gaithersburg, MD

Once COR On-Site Training 10 business days after installation

IV. ACCEPTANCE CRITERIA

The Contractor shall demonstrate that all performance specifications are met.

V. GENERAL INFORMATION

Safety: The Contractor employee shall be responsible for knowing and complying with commercial installation safety prevention regulations. Such regulations include, but are not limited to, general safety, fire prevention, and waste disposal.

Security: NIST is a restricted campus. An identification badge is required for access for entry into buildings and is also shown to the armed Security Police when entering the campus.

Identification Badges: Contractor employees shall comply with NIST identification and access requirements. The Contractor shall provide the name and citizenship information of employees for on-site visits to the NIST COR and SME prior to arrival. The COR and SME will submit the name(s) and citizenship information to the NIST Office of Security in order for a given Contractor employee to enter the NIST campus. The Contractor employee is responsible for absences due to missing or expired identification and access documents. Each Contractor employee shall wear a visible identification badge provided by the NIST Security Office.

Vehicle Registration: All Contractor employees must register their vehicles with the NIST

Security Office to gain access to the campus. A valid driver’s license, Government-furnished civilian ID (which in most cases can be a valid driver's license), proof of insurance, and current registration must be presented to the NIST Security Office.