Culture bags for cellular engineering

The National Institutes of Health (NIH) intends to award a fixed priced purchase order on a sole source basis to OriGen Biomedical Inc. Austin, TX 78744 to procure OriGen PermaLifeTM Cell Culture Bags for the Clinical Center/Department of Transfusion Medicine/Center for Cellular Engineering (CCE). CCE is an AABB accredited cellular therapy laboratory whose central mission is to provide services to the NIH Institutes to support more than 50 intramural clinical trials. CCE is responsible for the manufacture of human cells and tissue-based products utilized in Phase I/II clinical protocols for transplantation, adaptive immunotherapy and gene therapy conducted in the Clinical Center at the NIH.

Cell processing procedures are tailored to each of the many protocols supported in the Center for Cellular Engineering. These specific cell culture procedures utilizes blood that has been obtained from the patient in the Apheresis Clinic of the Department of Transfusion Medicine. The cultures are placed in an incubator for a week and the cells are then harvested and transfused into the patient or cryopreserved for later use. The specified culture bags to be procured are necessary to provide an inert closed system (to maintain sterility and maintain the integrity of antibodies, cytokines and other genetic material with high gas permeability for the optimum recovery of cells) and must maintain mechanical strength at temperatures down to -196˚C for cryopreservation. They are used in protocol specific procedures for cancer related to NK (Natural Killer) Cells, DC (Dendritic Cells) and TIL (Tumor Infiltrating Lymphocyte) Cells.

The proposed vendor, OriGen Biomedical, Inc. provides the only approved culture bags that can be used for these protocols. The protocols been approved by the Food and Drug Administration (FDA) and IRB (Institutional Review Board) for protocols #15-C0029; 17-C-0048 and additional protocols. No substitutions may be made without preapproval being sought by the FDA. The impact upon Dowling Apheresis Center would be that patients could not come in for Apheresis as these protocols would be canceled until a possible new source could be located and undergo a lengthy validation process during which time patient care for critically ill patients would be suspended as there would be lack of conformance with FDA requirements.

Item product list:
Part # Description Quantity
PL07 PermaLife Cell Celture Bag, 7mL 216 Bags
PL30 PermaLife Cell Celture Bag, 30mL 2348 Bags
PL70 PermaLife Cell Celture Bag, 70mL 275 Bags
PL 120 PermaLife Cell Celture Bag, 120mL 240 Bags
PL240 PermaLife Cell Celture Bag, 240mL 600 Bags
PL325 PermaLife Cell Celture Bag, 325mL 460 Bags
PC2-B Porective Cap for female luer 108 Cases

This acquisition is being conducted under the authority of the FAR Subpart 13.106-1(b)(i), Contracting officers may solicit from one source if the contracting officer determines that the circumstances of the contract action deem only one source reasonably available.
Interested concerns capable of providing the same or similar products or services as described in this notice may submit a capability statement outlining their capabilities. Capability Statements must be received within the time set forth in this synopsis to be considered by the Government. A determination to compete this proposed contract based on responses to this notice is solely within the discretion of the Government. Information received will normally be considered solely for the purpose of determining whether to conduct a competitive procurement. The total dollar value of this purchase order shall not exceed $250,000.00. The government reserves the right to increase the quantity of the contract in accordance with FAR 52.217-6.

Each response should include the following Business Information:
a. DUNS.
b. Company Name, address, POC, Phone and Email address
c. Current GSA Schedules or NAICS codes appropriate to this Award.
d. Type of Company (i.e., small business, 8(a), woman owned, hubZone, veteran owned, etc.) as validated in System For Award Management (SAM). All offerors must register on the SAM located at http://www.sam.gov/portal/SAM/#1
e. Capability Statement

Comments to this announcement may be submitted to the Clinical Center, Office of Purchasing and Contracts, prior to the closing date specified in this announcement, electronically to the attention of Malinda Dehner, Contract Specialist, dehnerm@cc.nih.gov by the due date and time marked in this notice.

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