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SAMDAILY.US - ISSUE OF MARCH 25, 2021 SAM #7056
SOLICITATION NOTICE

66 -- Procurement of a Microfluidic Resistive Pulse Sensor

Notice Date

3/23/2021 11:36:18 AM
 

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-FDA-1239700
 

Response Due

3/29/2021 8:00:00 AM
 

Archive Date

04/13/2021
 

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 FDA CDER Division of Product Quality Research (DPQR) as part of its research aimed at advancing domestic manufacturing of biologics and complex molecules assess the impact of formulation variables and manufacturing process on product quality. Identifying and characterization of subvisible particles is one of the analysis routinely performed to assess the quality and similarity of biologic drug products, nanomedicine and other complex parenteral products. However, characterizing subvisible particles lower than 2 microns is challenging due to the limitation of current instruments. Further due to the limited samples available for analysis a technique that requires low sample volume is required. The operation principle of the technique should be complimentary or orthogonal to techniques such as light scattering, nanoparticle tracking analysis, resonant mass measurement and flow imaging, techniques which are currently available in DPQR. To this end, the microfluidic pulse sensor is being purchased to fill this gap. Amendment 01:� The purpose of this Amendment 01 is to do the following: 1. To provide final responses to the questions received for the RFQ as part of the amendment.
 

Web Link

SAM.gov Permalink
(https://beta.sam.gov/opp/5fd014c126914b8f94be605e37d03589/view)
 

Place of Performance

Address: Silver Spring, MD 20993, USA

Zip Code: 20993

Country: USA
 

Record

SN05951195-F 20210325/210323230120 (samdaily.us)
 

Source

SAM.gov Link to This Notice
(may not be valid after Archive Date)

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