SOW FOR RFQ.pdf

Request for Quotation Number 1333ND21QNB640547

Statement of Work

TITLE: Modular microscale bioreactor system with single-use vessels

General Statement of Need

The Biomolecular Structure and Function (BSF) Group, Biomolecular Measurement Division, Materials

Measurement Laboratory, seeks to acquire a modular benchtop microscale bioreactor system with single use culture vessels that is suitable for 100-250 milliliter mammalian cell suspension cultures in support of ongoing biomanufacturing research and standards activities.

Background

The Biomolecular Structure and Function Group requires a microscale (100-250 mL) bioreactor system compatible with single-use culture vessels that is suitable for mammalian cell suspension cultures (1) to support ongoing research with Chinese hamster ovary cell (CHO)-based biomanufacturing and (2) to support new standards activities related to mammalian cell-based materials.

Scope/General Requirements

The Contractor shall deliver, install, and provide user training for one (1) modular benchtop microscale bioreactor system for use with single-use culture vessels (“bioreactor system” henceforth) meeting all requirements identified herein.

Specific Requirements

1. The bioreactor system must be a new instrument and not be a refurbished instrument.

2. The bioreactor system must include a warranty including, parts and labor valid for one year from date of acceptance by the Government.

3. The bioreactor system must be able to interface with an end-user provided Windows 10 personal computer (PC) using Contractor provided hardware and/or software for bioreactor system control locally or by network (remote). The Contractor shall specify the minimum system requirements for the

Government provided PC. Software must support monitoring and controlling the bioreactor system and recording bioreactor process data. Contractor must not require purchase of a PC as part of the bioreactor system purchase.

4. The bioreactor system must support independent, simultaneous operation of each culture vessel to include calibration of sensors, monitoring of process variables, proportional-integral-derivative (PID)-regulated manipulation of process variables through control of agitation, temperature, gassing and feed addition.

5. The bioreactor system must be equipped for at least four culture vessels (≥4) with working volumes ranging from 100-250 milliliters that can be controlled independently and simultaneously from a single control unit.

6. The bioreactor system must be capable of expansion with respect to the number of culture vessels such that at least eight (≥ 8) vessels with working volumes ranging from 100-250 milliliters can be controlled independently and simultaneously from a single control unit.

7. The bioreactor system must use pre-sterilized single-use culture vessels with connections and pitch-blade impeller(s) for mammalian cell culture; pre-sterilized single-use fluidics, fluidics lines and/or connections; and pre-sterilized single-use feed reservoirs. Each single-use vessel must be connected to at least three (≥ 3) single-use feed reservoirs having ≥ 50 milliliter capacity, each. Each single-use vessel must include an integrated exhaust gas condenser that can be cooled by the bioreactor system.

8. The bioreactor system must provide independent, simultaneous control of at least four (≥4) syringe-type pumps per active vessel for automated delivery of feed solutions to the culture vessel.

9. The bioreactor system must provide independent, simultaneous temperature control for each active culture vessel.

10. The bioreactor system must include independent, simultaneous culture agitation drive and control for

Request for Quotation Number 1333ND21QNB640547

Statement of Work each active culture vessel.

11. The bioreactor system must provide independent, simultaneous mass-flow-controlled mixing of air, oxygen, and carbon dioxide and headspace delivery for each active culture vessel.

12. The bioreactor system must provide independent, simultaneous sensing of culture foaming for each active vessel.

13. The bioreactor system must include instrumentation for independent, simultaneous measurement of culture pH and culture dissolved oxygen (DO) concentration for each active culture vessel.

14. The bioreactor system must include on-board cooling and/or refrigeration to less than or equal to 10 °C for liquids contained in feed reservoirs for each active culture vessel.

15. The Contractor shall provide equipment documentation and User Manual(s) in hard copy or electronic format.

Installation

The Contractor shall install the bioreactor system at the NIST laboratories located within the Institute for

Bioscience and Biotechnology Research (IBBR), 9600 Gudelksy Drive, Rockville, MD. Normal duty hours are

Monday through Friday, 8:30 am to 5:00 pm with the exception of Federal Holidays.

Installation shall include, at a minimum, uncrating/unpackaging of all equipment, set-up and hook-up of all equipment, start-up, demonstration of specifications, and removal of all trash. The Contractor must successfully demonstrate that all specific requirements are met at time of installation.

Training

The Contractor shall provide in-person training at NIST/IBBR for up to three NIST/IBBR personnel. The training shall cover all of the following, at a minimum: (1) instrument operating principles, (2) culture setup, processing and breakdown and (3) end-user maintenance and troubleshooting.

Completion of Work

All work shall be completed not later than 12 months from the date of award.