SOLICITATION NOTICE
66 -- Procurement of one (1) each PAK System Continuous Manufacturing Instrument
- Notice Date
- 6/4/2024 1:19:48 PM
- Notice Type
- Combined Synopsis/Solicitation
- NAICS
- 334516
— Analytical Laboratory Instrument Manufacturing
- Contracting Office
- FOOD AND DRUG ADMINISTRATION ROCKVILLE MD 20857 USA
- ZIP Code
- 20857
- Solicitation Number
- RFQ-121586-75F40124Q00284
- Response Due
- 6/17/2024 9:00:00 AM
- Archive Date
- 06/18/2024
- Point of Contact
- Sarah Hussain
- E-Mail Address
-
sarah.hussain@fda.hhs.gov
(sarah.hussain@fda.hhs.gov)
- Small Business Set-Aside
- SBA Total Small Business Set-Aside (FAR 19.5)
- Description
- 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.
- Web Link
-
SAM.gov Permalink
(https://sam.gov/opp/1ae3861e486f4582bf3710e4a31ba19c/view)
- Place of Performance
- Address: Beltsville, MD 20705, USA
- Zip Code: 20705
- Country: USA
- Zip Code: 20705
- Record
- SN07085995-F 20240606/240604230120 (samdaily.us)
- Source
-
SAM.gov Link to This Notice
(may not be valid after Archive Date)
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