Amendment One: AMBR15 and AMBR250 Single Use Bioreactors Operational Parts and Components.

Solicitation Number:75F40124Q00499_A00001 Amendment One The following amendment is to add FAR Clause 52.216-3, and Extend the Response time to August 29,2024 at 4:00 pm ET. The changes are highlighted in Red in the Attachement "RFQ CDER-2024-123841 08282024". ************************************************************************************* This is a combined synopsis/solicitation for commercial services prepared in accordance with the format in FAR 12.6 and FAR 13 as supplemented and additional information included in this notice. The incorporated provisions and clauses are those in effect through Federal Acquisition Circular (FAC) 2024-05, effective 05/22/2024. THIS ANNOUNCEMENT CONSTITUTES THE ONLY SOLICITATION AND A SEPARATE SOLICITATION WILL NOT BE ISSUED. The solicitation number for this acquisition is 75F40124Q00499 and is being issued as a Request for Quote (RFQ). The NAICS Code for this solicitation is 334516 and the Small Business Size Standard is 1000 employees. This will be awarded as Firm-Fixed Price and completed as a full and open competition. Prospective Offerors are responsible for downloading the solicitation and any amendments from SAM.GOV. The Government reserves the right to award an order without discussions if the Contracting Officer determines that the initial offer is providing the Best Value and discussions are not necessary. The U.S. Food and Drug Administration (FDA) requires operational parts and components for single-use bioreactors (Sartorius AMBR15 and AMBR250) BACKGROUND AND OVERVIEW OPQR currently owns and operates a Sartorius ambr15 48-way microbioreactor system (Generation 1; Serial No. R3-0147) and an ambr250 modular system that enables parallel automated operation of eight (8) single-use mini-bioreactors (Serial No. 44a250m-CM1010). To date, these two systems have provided several significant benefits to OPQR research by reducing time, labor, and raw materials necessary compared to the operation of larger scale bioreactors that are manually assembled, cleaned, and sanitized. In addition to convenience, both systems greatly improve experimental throughput and robustness. Several OPQR projects investigating the impacts of manufacturing process changes on recombinant protein product quality, such as monoclonal antibodies, have utilized these instruments. The current workload of these instruments requires that they always perform accurately, which requires frequent replacement of operational parts, components, and peripherals that are compatible with our ambr15 and ambr250 instruments. This requirement is for a supply of Ambr15 and Ambr250 parts and components that will support multiple research projects occurring this year. See attachment in Full Text, RFQ CDER-2024-123841 08202024