Loren Data's SAM Daily™

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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