SAMDaily.us | PRESOL | 66 | Procurement of one (1) each Integrated Continuous Purification System

SAMDAILY.US - ISSUE OF JULY 18, 2022 SAM #7535
SOLICITATION NOTICE

66 -- Procurement of one (1) each Integrated Continuous Purification System

Notice Date: 7/16/2022 8:32:51 AM
Notice Type: Combined Synopsis/Solicitation
NAICS: 334516 — Analytical Laboratory Instrument Manufacturing
Contracting Office: FDA OFFICE OF ACQ GRANT SVCS Beltsville MD 20705 USA
ZIP Code: 20705
Solicitation Number: FDA-RFQ-110403
Response Due: 7/27/2022 9:00:00 AM
Archive Date: 07/28/2022
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 an integrated cell culture process in the continuous manufacturing (CM) system for a model therapeutic protein drug product.� CDER currently lacks a system to integrate the manufacturing steps required to purify therapeutic protein drug product from the harvested cell culture bioreactor material in the CM process. As a result, CDER requires a purification system to support the integration of an automated, synchronous purification schematic into continuous manufacturing of a model therapeutic protein drug product.�
Web Link: SAM.gov Permalink
(https://sam.gov/opp/65fc0cd2e413478896d0f57280758435/view)
Place of Performance: Address: Silver Spring, MD 20993, USA; Zip Code: 20993; Country: USA
Record: SN06391424-F 20220718/220716230104 (samdaily.us)
Source: SAM.gov Link to This Notice
(may not be valid after Archive Date)

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