SPECIAL NOTICE
66 -- Miltenyi ClinicMACS Prodigy
- Notice Date
- 8/25/2021 11:16:18 AM
- Notice Type
- Special Notice
- NAICS
- 334516
— Analytical Laboratory Instrument Manufacturing
- Contracting Office
- NIH NCI ROCKVILLE MD 20852 USA
- ZIP Code
- 20852
- Solicitation Number
- 75N91021Q00258
- Response Due
- 9/1/2021 9:00:00 AM
- Archive Date
- 09/16/2021
- Point of Contact
- Miguel Diaz
- E-Mail Address
-
miguel.diaz@nih.gov
(miguel.diaz@nih.gov)
- Description
- National Cancer Institute (NCI), Pediatric Oncology Branch (POB), Center for Cellular Engineering (CCE) plans to procure a Miltenyi ClinicMACS Prodigy from Milteyni Biotec Inc., 2303 Lindbergh Street, Auburn, CA 95602 on a sole source basis. This acquisition will be processed under FAR Part 12 � Acquisition for Commercial Items and will be made pursuant to the authority in FAR 13.106-1 (b)(1)(i) using simplified acquisition procedures for commercial acquisitions.� The response close date of this notice for this requirement is in accordance with FAR 5.203(a)(1). The North American Industry Classification System code is 334516 and the business size standard is 1,000 employees. The Pediatric Oncology Branch (POB) is actively investigating multiple novel adoptive CAR T-cell trials and has gained familiarity and experience with manufacturing of CAR T-cells on the ClinicMACS Prodigy system. Purchase of this device will facilitate the more rapid translation and preclinical testing needed to bring forth novel CAR T-cell constructs into the clinic. Based on ongoing discussions within the POB/CCE and other interested parties working on adoptive cell therapy, an additional device is needed to support development of CAR T-cell therapy. The Center for Cellular Engineering (CCE) manufactures cell-based therapies for patients enrolled on first in human clinical trials at the Clinical Center of NIH. The device requested for purchase reduces the need for complex open processing of patient's cells and thus decreases the likelihood of contamination of the cell therapy during manufacturing. The device is closed, fully automated device that fractionates, washes, expands and formulates cell-based therapies and produces a consistently manufactured product. The Closed System nature of this device reduces manufacturing failures from contamination. It reduces the training needed by technicians to manufacture these products and it increases the degree of compliance with FDA mandates that govern the cell therapy manufacturing. This acquisition will further CCE mission to provide advanced cell therapies for patients enrolled on NIH sponsored clinical trials. This is a new requirement. This purchase will allow the CCE to increase compliance with FDA mandates, reduce overall operational costs, and increase throughput by allowing one technician to manufacture more than one therapy simultaneously. Additionally, it will facilitate the testing of preclinical constructs before they are translated to be put into the clinic. The POB currently has its CAR T-cell products planned to be manufactured on the Prodigy and has acquired experience with its utilization. Request of this device will facilitate future development. The CliniMACS Prodigy represents the next generation in automated cell processing. This device offers advanced integrated solutions hardware and custom software programs to streamline cell processing workflows. The CliniMACS Prodigy offers a flexible platform for cell processing applications enabling the magnetic separation of different cell types as well as customized cell processing protocols. The cell processing unit is fully automated for washing, fractionating and cultivating of cells. These processing steps take place in a single-use chamber, which is included as part of specific CliniMACS Prodigy Tubing Sets. The magnetic cell separation unit comprises a second integral component, enabling the separation of virtually any cell type allowing for the production of bespoke therapies for patients. The modular nature of the device allows it to replace multiple devices in a fully closed system which reduces the chances of inadvertent contamination of the product with micro-organisms or cross contamination with another therapy in a situation where multiple therapies are manufactured concurrently. CCE currently has 4 of these devices and has extensive knowledge of their use in cGMP manufacturing. CCE has researched the bioreactor device market, and to the extent of research, we are unable to identify a comparable device which meets all of the program needs with the track record of this device. To choose another device from another manufacturer would require extensive preclinical testing which would negatively impact the CCE�s mission to provide cell therapies for patients enrolled on clinical. Additionally, this testing would require a significant investment in manpower, time and resources. The following product features/characteristics are essential to help achieve the mission of CCE: Device must be capable of cell fraction via magnetic beads Device must be capable of activating lymphocyte cell division and expansion Device must be able to transduce lymphocytes via lentiviral and retroviral transduction Device must be capable of washing the cell product Device must be capable of concentrating the product for final formulation Device must be fully cGMP compliant Software must be part 11 compliant for full traceability Company must have a strong local presence to support maintenance/repairs/trouble shooting issues. Company must have 24/7 support as the device will be used to manufacture treatments for patients. This notice is not a request for competitive quotation. However, if any interested party, especially small business believes it can meet the above requirement, it may submit a capability statement for the Government to consider. The response and any other information furnished must be in writing and must contain material in sufficient detail to allow NCI to determine if the party can perform the requirement.� Responses must be received in the contracting office by 12:00 PM ET, on September 1, 2021.� All responses and questions must be via email to Miguel Diaz, Contracting Officer at miguel.diaz@nih.gov.� A determination by the Government not to compete this proposed requirement based upon responses to this notice is solely within the discretion of the Government. Information received will be considered solely for the purpose of determining whether to conduct a competitive procurement.� In order to receive an award, contractors must be registered and have valid certification through SAM.GOV and have Representations and Certifications filled out. Reference: 75N91021Q00258 on all correspondence.
- Web Link
-
SAM.gov Permalink
(https://beta.sam.gov/opp/f13d41200bb74476a17023c156e3380e/view)
- Record
- SN06110261-F 20210827/210825230127 (samdaily.us)
- Source
-
SAM.gov Link to This Notice
(may not be valid after Archive Date)
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