Procurement of one (1) each PAK System Continuous Manufacturing Instrument
Closed Solicitation Posted
- Solicitation number
- RFQ-121586-75F40124Q00284
- Agency
-
Food and Drug Administration
Department of Health and Human Services
- Responses due
- Set-aside
- Total Small Business
Opportunity facts
- NAICS code
- 334516 Analytical Laboratory Instrument Manufacturing
- PSC
- 6640 Laboratory Equipment And Supplies
- Place of performance
- Beltsville, Maryland 20705, United States
- Points of contact
Notice details come from SAM.gov. Updated .
About this opportunity
The Food and Drug Administration's (FDA) Center for Drug Evaluation and Research (CDER) is seeking to procure one (1) PAK System Continuous Manufacturing Instrument. CDER requires this bench-scale instrument to support an automated, synchronous purification process in the continuous manufacturing of a model therapeutic protein drug product. The instrument must be capable of interacting with CDER's existing pilot-scale PAK System instrument to operate end-to-end continuously, with automated controls for simultaneous operation of purification steps and feedback control through PAT instrumentation. Quotes will be evaluated on a lowest price, technically acceptable basis, and are due by June 17, 2024.
This is a 100% small business set-aside procurement. The period of performance is 12 months with four 12-month option periods for the preventative maintenance service contract. The place of performance is Calverton, MD 20705, USA. No potential incumbents or current contractors are mentioned, and the award value or budget range is not provided in the solicitation notice.
Notice text
The Office of Biotechnology in the Food and Drug Administration’s CDER currently has a semi-purification process in the continuous manufacturing(CM) of a model therapeutic protein drug product using one pilot-scale PAK System Continuous Manufacturing instrument. CDER requires a bench-scale PAK System Continuous Manufacturing instrument to support an automated, synchronous purification schematic in the continuous manufacturing of a model therapeutic protein drug product. The PAK System Continuous Manufacturing instrument shall be capable of interacting with the currently FDA/CDER owned PAK System Continuous Manufacturing instrument to operate end-to-end continuously with automated controls for simultaneous operation of purification steps as well as allow for feedback control of the continuous purification process through PAT instrumentation.
Files
| File | Type | Posted |
|---|---|---|
| RFQ-121586-75F40124Q00284_May2024.pdf |
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