Attachment 1 - Purchase Description.pdf

PURCHASE DESCRIPTION

Bioreactor System for Recombinant Protein Production

1. Statement of Need and Purpose:

The National Institute of Neurological Disorders and Stroke (NINDS), Brain MRI Molecular Contrast Unit requires a bioreactor system for recombinant protein production.

2. Background Information and Objective:

NINDS’ Brain MRI Molecular Contrast Unit (BMMCU), led by Dr. Alan Koretsky, is developing a novel class of brain MRI contrast agents that will provide improved contrast of specific brain pathologies. Producing sufficient amounts of contrast agent requires scaling up the production of recombinant proteins to a level above the typical yield producible through the standard cultivation methods as utilized at the BMMCU Laboratory. Therefore, the BMMCU requires a bioreactor system to facilitate the increased production of recombinant protein.

3. Generic Name of Product:

Bioreactor system; fermentation system

4. Product Description and Salient Characteristics:

The bioreactor system shall include an autoclavable, glass vessel/stirrer; a compatible bioreactor control station; and native or integrated software that interacts with and operates the bioreactor vessel and control station for execution of fermentation processes.

The bioreactor system must have the following physical, functional, or performance characteristics:

a. User control of pH level, temperature, dissolved oxygen, foam/level, and agitation.

b. Maximum dimensions (L x W x H): 30 in x 30 in x 36 in

c. The bioreactor control station shall include integrated pH monitoring and controller, integrated dissolved oxygen monitoring and controller for PID-controlled infusion of oxygen, automatic dissolved oxygen controller, and integrated anti-foam monitoring and controller.

d. PID-controlled dosing of base via fast load pumps.

e. Cooling system to prevent overtempt of process.

f. Heating jacket with temperature monitoring and controller.

g. An exhaust air cooling system.

h. Minimum of one, external, variable speed pump, including required connection cable(s)/hose(s).

i. A substrate pump controller for the variable speed pump.

j. One autoclavable, glass vessel/stirrer that has:

i. Mechanical seal

ii. Minimum working volume of 2 liters

iii. Stainless steel lid and stainless-steel vessel stand

iv. Separate ports for exhaust air cooling system, dissolved oxygen probe, pH probe, foam/level probe, sparger, baffles, inoculation probe, and harvest pipe.

v. A coupling for stirrer shaft and motor, including rubber sleeve for direct drive.

vi. Impellers compatible with the vessel/stirrer.

vii. A sparger pipe with ring sparger, including nozzles for hose connection.

viii. PTFE sterilizing-grade membrane filters for bioreactor exhaust and inlet. Filters must be sterilizable at least 20 times at 121 degrees Celsius and must have hose connections on both sides.

5. Quantity: One (1) Bioreactor System

6. Delivery Terms:

The contractor shall deliver the Bioreactor System to the address specified in the Government’s Purchase Order within thirty (30) days after acceptance of the Purchase Order.

The Bioreactor System shall be delivered to: National Institutes of Health, 10 Center Drive, Room 5C100, Bethesda, Maryland 20892, between the hours of 9:00 am and 5:00 pm eastern standard time, Monday through Friday except Federal holidays.

Delivery shall be Freight on Board (FOB) destination and include inside delivery.

When the Bioreactor System is ready to be shipped, the Contractor shall confirm delivery information with the Contracting Officer’s Representative designated in the Purchase Order.

7. Warranty Terms:

The Contractor shall warrant that all components of the Bioreactor System will be free from material or workmanship defects for a minimum period of twelve (12) months after delivery and acceptance of same (Warranty Period).

During the Warranty Period, the Contractor shall be responsible for scheduling and effectuating all required service and repair of the Bioreactor System, as recommended by the manufacturer, onsite.

All service and repair required during the Warranty Period shall be provided at no additional cost to the Government, performed by original equipment manufacturer (OEM)-certified technicians, and use only OEM-approved parts.

The Bioreactor System Warranty includes all software updates recommended or required by the OEM.