SOLICITATION NOTICE
Q -- Creation of KT64.41BBL.A2 Working Cell Bank
- Notice Date
- 5/14/2014
- Notice Type
- Presolicitation
- NAICS
- 621511
— Medical Laboratories
- Contracting Office
- Department of Health and Human Services, National Institutes of Health, National Cancer Institute, Office of Acquisitions, 9609 Medical Center Drive, Room 1E128, Rockville, Maryland, 20852, United States
- ZIP Code
- 20852
- Solicitation Number
- N02RC42531-83
- Archive Date
- 6/12/2014
- Point of Contact
- Gwennifer K. Epps, Phone: 240-276-5445, Terry Galloway, Phone: 240-276-5384
- E-Mail Address
-
eppsg@mail.nih.gov, gallowaytl@mail.nih.gov
(eppsg@mail.nih.gov, gallowaytl@mail.nih.gov)
- Small Business Set-Aside
- N/A
- Description
- The National Cancer Institute (NCI), Center for Cancer Research (CCR), Pediatric Oncology Branch (POB), plans to procure on a sole source basis: supplies, sterility- immersion testing- setup and first sample, sterility- immersion testing- each additional sample submitted, B/F test immersion, in vitro assay for adventitious virus contaminants for the generation of KT32.A2.41BBl.64 clone 2D11 viable reagent cell bank to generate GMP grade expanded NK cells, from the Clinical Cell and Vaccine Production Facility (CVPF), University of Pennsylvania Abramson Cancer Center, 3451 Walnut St, Philadelphia, PA 19104-6205, United States. This acquisition will be processed in accordance with simplified acquisitions procedures as stated in FAR Part 13 13.106-1(b)(1) and is exempt for the requirements of FAR Part 6. The North American Industry Classification System code is 621511, and the business size standard is $30.0 million. Only one award will be made as a result of this solicitation. This will be awarded as a firm fixed price type contract. It has been determined there are no opportunities to acquire green products or services for this procurement. Note: the Period of performance has not been determined at this time. A sole source to Cell and Vaccine Production Facility is the only source for the working cell bank since they were the creator of the cell bank and have the intellectual property rights to the bank. The Pediatric Oncology Branch conducts clinical trials in acute lymphoblastic leukemia, pediatric sarcomas, neuroblastoma, brain tumors, malignant melanoma, neurofibromatosis, and Phase I trials. The Pediatric Oncology Branch is dedicated to improving outcomes for children and young adults with cancer and genetic tumor predisposition syndromes. NCI conduct translational research that spans basic science to clinical trials. The clinical studies are performed in an environment that supports NCI patient's medical and emotional needs, alongside cutting edge scientific research. The mission of the Immunology Section of the Pediatric Oncology Branch is to develop effective immune based therapies for childhood cancer. Previous work has demonstrated T cells and NK cells can be efficiently expanded ex vivo using artificial antigen presenting cells (aAPCs) expressing 4-1BBL. NCI has previously purchased an aAPC master cell bank produced by The Cell and Vaccine Research Center at the Abramson Cancer Institute at the University of Pennsylvania expressing which expresses CD64, 4-1BBL and HLA-A2. These cells potently expand NK cell populations and NCI plans to use it to expand NK cells for use in a clinical trial of adoptive immunotherapy following allogeneic stem cell transplantation. This project will create a GMP grade working cell bank from the above mentioned master cell bank for use in NCI's upcoming clinical trial. The choice of WuXi Apptec for validation of the working cell bank is based upon the fact that WuXi Apptec was used to qualify the master cell bank and therefore has already performed the quality control testing on these cell banks and therefore has unique experience and expertise in the evaluation of this product. If NCI were to use an alternative contractor, there would be significant new variable introduced into the analyses, which could adversely affect that ability to interpret results. In addition, the project will create a 200vial working cell bank containing vials of KT64.41BBL.A2 containing 100 x 10 6 cells/vial. These cells will be used directly for clinical trials of adoptive immunotherapy with activated NK cells. The following tests will be conducted on the CD64, HLA-A2, 4-1BBL Master Cell Bank using Good Laboratory Practice Standards the results will be provided to the Project Director to be included in the submission packet to the FDA for the IND for this product. Detailed technical requirements (Contractor Requirements) 1. The contractor must provide a laboratory environment, which conforms to good laboratory practice requirements. 2. The contractor must have specific experience with the performance the assessment and testing for master cell banks required by the US FDA. 3. The contractor will qualify all media, culture bags and reagents used in the production process. 4. The contractor will perform a quality assurance review of manufacturing records and test results for compliance with FDA standards. 9. The contractor will provide the results of the studies for inclusion in the chemistry, manufacturing and controls section of IND referencing Master Cell Bank and Working Cell Bank prior to FDA submission. 10. Work should be completed within 3 months of initiation of the contract. This is not a solicitation for competitive quotations. However, if any interested party especially small business, believes they can meet the above requirement, they may submit a statement of capabilities. All information furnished must be in writing and must contain sufficient detail to allow the NCI to determine if it can meet the above unique specifications described herein. An original and one copy of the capability statement must be received in the NCI Office of Acquisitions on or before 11:00 AM EST on, May 28, 2014. No electronic capability statements will be accepted (i.e. email or fax); an original and one copy must be sent to the NCI Office of Acquisitions at the address stated above. All questions must be in writing and can be faxed (240) 276-5401 or emailed to Gwennifer Epps, Contracting Officer at eppsg@mail.nih.gov. A determination by the Government not to compete this proposed contract 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 have valid registration and certification in the Central Contractor Registration (CCR) and the Online Representations and Certifications Applications (ORCA), through sam.gov. No collect calls will be accepted. Please reference solicitation number N02RC42531-83 on all correspondence.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/NIH/RCB/N02RC42531-83/listing.html)
- Place of Performance
- Address: 10 Center Drive, Bethesda Drive, Maryland, 20892, United States
- Zip Code: 20892
- Zip Code: 20892
- Record
- SN03365496-W 20140516/140514234209-331f09cc3cce2b2fc8d5bf8b37e0e7bd (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
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