Inactive Total Small Business Set-Aside (FAR 19.5)

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... 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.