Manufacture of a GMP lot of Lentiviral Vector encoding a CD22 Targeting Chimeric Antigen Receptor (CD22 CAR) Gene for Clinical Use

National Cancer Institute (NCI), Center for Cancer Research (CCR), Pediatric Oncology Branch (POB) plans to procure, on a sole source basis, a GMP lot of vector from Lentigen Technologies, Inc., 910 Clopper Road, Suite 200S Gaithersburg, MD 20878.
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)(2) and 13.501-(a)(1) using simplified acquisition procedures for commercial acquisitionist. The North American Industry Classification System code is 325414 and the business size standard is 1,250 employees.
It has been determined there are no opportunities to acquire green products or services for this procurement.
The National Cancer Institute (NCI), Center for Cancer Research (CCR), Pediatric Oncology Branch (POB) has a requirement for GMP grade lentiviral encoding a chimeric antigen receptor (CAR) targeting CD22. This requirement is necessary to support the clinical activity of an ongoing clinical trial where vector was previously provided. The anti-CD22 CAR trial has accrued 39 patients to date and based on the efficacy and experience to date, additional vector is being requested to support ongoing research of this CAR in the relapsed/refractory population. To maintain consistency with the treatment in this clinical, consistency of the vector is required.
The requirements are to (1) generate clinical-grade lentiviral vector in a GMP complaint manner using vector plasmids provided by the NCI POB Investigator; (2) perform quality control certification testing on vector as requested by the NCI Technical Point of Contact.
All manufacturing and testing will be performed in order to meet current requirements for GMP Phase I/II FDA Submissions. DNA sequencing and potency (titer and function) documentation is the responsibility of the Contractor. It is the responsibility of the Contractor to insure all FDA certification requirements are being met.
Manufacture of GMP lentiviral Vector Encoding the CD22 CAR:
Certification tests to be performed on the GMP lot of vector include:

Sterility-USP/EP, no growth within 14 days as determined by aerobic and anaerobic culture for bacteria and fungus
B/F-USP/EP, no interference as determined by USP
Mycoplasma-Points to Consider/EP, negative as determined by direct and indirect inoculation
Total Protein, report results as determined by micro BCA assay
Endotoxin, < 10 EU/ml as determined by LAL
T-ag, report results as determined by qPCR
Replication Competent Lentivirus Testing (RCL), no evidence of RCL or VSVG as determined by supernatant testing on C8166 cells with amplification and indicator phases
In vitro viral assay, No CPE or hemadsorption as determined by assay on MRC-5, Vero and A549 (or HEK) cells
Identity, gene specific sequence present as determined by qPCR
Transducing Titer, report results as determined by qPCR
Residual Benzonase, <0.2 ng/mL as determined by ELISA
Residual VSVg, report results as determined by qPCR
Residual BSA, report results as determined by ELISA
Physical titer, report results as determined by P24 ELISA
Fill Volume, > required volume, determined by direct measurement
pH, potentiometric, 7.0 - 7.5
Appearance, clear to slightly opalescent/colorless as determined by unaided visual inspection
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 proposal or quote 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 3:00 PM ET, on April 2, 2018. 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: N02RC85009-45 on all correspondence.