# Procurement of one (1) each PAK System Continuous Manufacturing Instrument

Canonical: https://abierto.us/opportunities/rfq12158675f40124q00284

- Solicitation number: RFQ-121586-75F40124Q00284
- Notice type: Combined synopsis and solicitation
- Status: Closed. Deadline was June 17, 2024 at 12:00 PM EDT
- Department: Department of Health and Human Services
- Agency: Food and Drug Administration
- Contracting office: Food and Drug Administration (75F402)
- NAICS: 334516 Analytical Laboratory Instrument Manufacturing
- Product or service code: 6640 Laboratory Equipment and Supplies
- Set-aside: Total small business set-aside
- Place of performance: Beltsville, Maryland
- County: Prince George's County (FIPS 24033). https://abierto.us/counties/prince-george-s-county-md-24033
- City: Beltsville. https://abierto.us/cities/beltsville-md-2406400
- First posted: June 4, 2024
- Last posted: June 4, 2024
- SAM.gov: https://sam.gov/workspace/contract/opp/1ae3861e486f4582bf3710e4a31ba19c/view

## 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.

## Publications

- June 4, 2024: Combined synopsis and solicitation, due June 17, 2024 at 12:00 PM EDT. Notice 1ae3861e486f4582bf3710e4a31ba19c. https://sam.gov/workspace/contract/opp/1ae3861e486f4582bf3710e4a31ba19c/view

## Points of contact

- Sarah Hussain, sarah.hussain@fda.hhs.gov

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Source: SAM.gov Contract Opportunities bulk extract. Confirm deadlines on SAM.gov before responding. Cite https://abierto.us/opportunities/rfq12158675f40124q00284.