SOLICITATION NOTICE
J -- Upgrade of a Homogenized Model deBEE 1000
- Notice Date
- 5/20/2011
- Notice Type
- Presolicitation
- NAICS
- 811219
— Other Electronic and Precision Equipment Repair and Maintenance
- Contracting Office
- Department of Health and Human Services, National Institutes of Health, National Heart, Lung and Blood Institute, Rockledge Dr. Bethesda, MD, Office of Acquisitions, 6701 Rockledge Dr RKL2/6100 MSC 7902, Bethesda, Maryland, 20892-7902
- ZIP Code
- 20892-7902
- Solicitation Number
- NHLBI-CSB-(HL)-2011-180-DDC
- Archive Date
- 6/8/2011
- Point of Contact
- Deborah - Coulter, Phone: (301) 435-0368
- E-Mail Address
-
dc143b@nih.gov
(dc143b@nih.gov)
- Small Business Set-Aside
- N/A
- Description
- THIS IS A NOTICE OF INTENT, NOT A REQUEST FOR A PROPOSAL. A SOLICITATION DOCUMENT WILL NOT BE ISSUED AND PROPOSALS WILL NOT BE REQUESTED. The COAC Services Branch, Office of Acquisitions, DERA, National Heart, Lung, and Blood Institute (NHLBI), NIH, for the Laboratory of Molecular virology and Gene Therapy (LMVGT), NHLBI, Division of Intramural Research (DIR), intends to award a purchase order on a sole source basis to BEE International Inc., for the following upgrade outlined in the statement of work below. The reference number: NHLBI-CSB-(HL)-2011-180-DDC. Background Information The National Institutes of Health (NIH), National Heart, Lung, and Blood Institute (NHLBI), Laboratory of Molecular Virology and Gene Therapy (LMVGT), developed processes for producing recombinant adeno-associated virus (rAAV) in suspension cultures. The rAAV prepared in LMVGT is used in preclinical research to assess the potential therapeutic benefits in animal models of Duchenne muscular dystrophy (DMD). The rAAVare produced in stirred-tank bioreactors using cultured cells in a nutrient growth medium. The rAAV remains mostly intracellular and a mechanical homogenizer provides an efficient method for recovering the product. As the cell culture volumes increase, unless the processing equipment is proportionally scaled-up, the processing time becomes a major bottleneck and compromises the quality and quantity of the product. At these relatively large volumes, the efficiency of production becomes a major investment. For example, recovering 50% of rAAV from 200 liters is equivalent to 20% recovery from 500 liters, but the cost of the latter is 2.5x the smaller volume. Currently, the rAAV produced from 200 liters provides sufficient material for testing in 2 to 4 animals. We would prefer to increase manufacturing capacity to 500 liters which would allow us to evaluate the effects in a larger animal group at higher. This is not possible with the current equipment. Therefore, the upgrade to the current equipment is essential for the goals of the laboratory to develop gene therapy applications for DMD. Purpose and Objectives for the Procurement The specific objective of this requirement is to upgrade the government owned homogenizer, Model deBEE 1000, manufactured by BEE International in order to increase the cell culture production capacity. Approximately 4-weeks after receipt of the Homogenizer from the Government, is estimated to complete the upgrade. Contractor Requirements The contractor, BEE International will repair and upgrade the BEE International Homogenizer, Model deBEE 1000, to increase the flow rate from 1 liter per min to 3 liters per minute, to the specifications of the BEE International Homogenizer, Model deBEE 3003. At a minimum, the repair and upgrade shall include: ~ Modification to increase the flow rate capacity from 1 liter to 3-liters per minute. ~ Increase the operating pressure from 2,000 to 15,000 PSI (variable). ~ Replace the piston and high-pressure cylinders with new components compatible with the reconfigured piston and cylinder assemblies. This include, new check valves, heat exchanger, and outlet valve. ~ Design a new reaction chamber that operates at the higher flow rate. ~ Install a new process pressure gauge. ~ Scale the reaction chamber and the high pressure pistons/cylinders. ~ Repair the motor and other parts as needed for any performance problems. ~ Perform overall system inspection and maintenance. Government Responsibilities The NHLBI, LMVGT shall: ~ Package and ship the Homogenizer, in accordance with the manufacturer's specifications to BEE International's location for repair and upgrade. ~ Communicate with the Contractor during the performance of the repair and upgrade. Reporting and Deliverable Requirement The Contractor shall deliver one fully functional Homogenizer upgraded from a BEE International Homogenizer, Model deBEE 1000, to a BEE International Homogenizer, Model deBEE 3003, within 4-weeks upon receipt from the Government. The upgraded Homogenizer shall be delivered to: Robert M. Kotin, Ph.D. NHLBI, LMVGT 10 Center Drive, Room 7D05, MSC 1654 Bethesda, Maryland 20892 - 1654 Telephone Number: 301- 496-1594 Email: kotinr@nhlbi.nih.gov Program Management and Control None applicable. Inspection and Acceptance Inspection of the upgraded BEE International Homogenizer, Model deBEE 3003, will be performed at the NHLBI, LMVGT within 24-hours after receipt. Acceptance by the NHLBI, LMVGT, Project Officer, of the upgraded BEE International Homogenizer, Model deBEE 3003, will occur and conveyed to the contractor within 24-hours after inspection. Attachments None applicable. The sole source determination is based on the fact that the specific objective of this requirement is to upgrade the government owned homogenizer, Model deBEE 1000, manufactured by BEE International in order to increase the cell culture production capacity. This machine is utilizes as a hydraulic system and two pistons to generate 15,000 PSI with approximately 1 liter per minute flow rate. The BEE International pilot scale homogenizers utilize a proprietary reaction chamber, pistons, and cylinders (covered by US patents 6,746,213; 6,749,329; 6,443,610; and 5,720,551)... The unit has functioned well for our small-scale and mid-scale processes, but this flow rate is limiting for the larger volumes used for the current production process. With volumes up to 500 liters, the time required for this one step would exceed 8 hrs and realistically require at least 10 hr. BEE International has the capabilities to re-configure the current instrument to the larger capacity system. The deBEE 1000 uses the same platform and architecture as the larger capacity deBEE 3003 homogenizer, which processes 3 liters per minute. The equipment modification involves scaling the proprietary reaction chamber and the high-pressure pistons/cylinders to achieve the increased flow rates. Therefore, it is in the Government's best interest to return the unit to the manufacture for the upgrade. The notice of intent is not a request for competitive proposals. Only one responsible source and no other supplies or services will satisfy agency requirements. Industry Classification (NAICS) Code is 811219, Other Electronic and Precision Equipment Repair and Maintenance with size standard of $19.0M; the small business set-aside does apply for this requirement. The acquisition is being conducted under FAR Part 13, simplified acquisition procedures, therefore the requirements of FAR Part 6 B Competitive Requirements are not applicable (FAR Part 6.001) and the resultant purchase order will include all applicable provisions and clauses in effect through the Federal Acquisition Circular (FAC) 05-50 (April 15, 2011). This notice of intent is not a request for competitive proposals. Interested parties may identify their interest and capabilities in response to this synopsis, by May 27, 2011, 7:30 am Eastern Standard Time. The determination by the Government not to compete the proposed contract based upon responses to this notice is solely within the discretion of the Government. Information received will normally be considered solely for the purpose of determining whether to conduct future competitive procurement.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/NIH/NHLBI/NHLBI-CSB-(HL)-2011-180-DDC/listing.html)
- Place of Performance
- Address: NIH, Bethesda, Maryland, 20892, United States
- Zip Code: 20892
- Zip Code: 20892
- Record
- SN02453803-W 20110522/110520235405-7d8a6c84e8d706d105e22a17d7fc21c6 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
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