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SAMDAILY.US - ISSUE OF JUNE 06, 2024 SAM #8227
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
 
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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