National Cancer Institute (NCI), Center for Cancer Research (CCR), Pediatric Oncology Branch, plans to procure on a sole source basis the services for the manufacture of a GMP lot of Lentiviral vector CD19/CD22 bi CAR gene for clinical use from Lentigen Technology Inc.; 910 Clopper Road, Suite 200 S; Gaithersburg, MD 20878.
The response close date of this notice for this requirement is in accordance with FAR 5.203(a)(1). This acquisition will be processed under FAR Part 12 - Acquisition for Commercial Items and in accordance with simplified acquisition procedures as stated in FAR Part 13.106-1(b)(2), and is exempt from the requirements of FAR Part 6. The North American Industry Classification System code is 352413 and the business size standard is 1,250 employees.
Only one award will be made as a result of this solicitation. This will be awarded as a firm fixed price, type contract.
The period of performance: delivery will be twelve (12) months from date of award.
It has been determined there are no opportunities to acquire green products or services for this procurement.
The Pediatric Oncology Branch, NCI, CCR is committed to bringing new cutting edge therapies to children with leukemia. The POB has been instrumental in treating children with T-lymphocytes (white blood cells from the patient) that have been modified with retroviral gene vectors. It currently has an open clinical trial for T-cells modified with a CAR specific for the leukemia tumor antigen C019.
The gene vector for CD19-CAR was produced by the NCI Surgery Branch. The POB's recent research has identified that another leukemia tumor antigen, CD22, is also a high value target and have validated activity in an ongoing clinical trial in the POB. Importantly loss of CD19 has been observed as a mechanism for leukemic resistance. The POB has developed a CAR construct that targets both CD19 and C022 and is based on the C019 and CD22 single targeting CARs used in clinical trials in the POB.
This requirement is for the production of GMP-grade, fully tested lentiviral CD19/CD22 bispecific CAR vector. The creation of gene vectors, and especially what the POB entails here, a GMP grade, high-titer vector that can be qualified for subsequent clinical use, is not normally a commercial enterprise. Lentigen Technology, Inc. has a track record of consistently producing such vector in a clinic-ready manner. The overall objective of this proposal is to provide the NCI CCR POB Investigators with GMP compliant production and testing services. Material will be produced under Standard Operating Procedures to be compliant with FDA regulations for the eventual generation of Phase 1/11 clinical material.
Contractor shall perform the following:
SCOPE OF WORK:
The Contractor shall provide the Investigators of the NCI CCR POB with a lentiviral vector CD19/CD22 biCAR gene following cGMP standards. Material must be produced under Standard Operating Procedures to be compliant with FDA regulations for Phase I/II clinical material.
TECHNICAL REQUIREMENTS:
The Contractor shall: (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 CD19/CD22 biCAR:
Certification tests to be performed on the GMP lot of vector include:
Sterility-USP/EP, no growth within fourteen (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
PERIOD OF PERFORMANCE:
The maximum Period of Performance shall be twelve (12) months as indicated in the Purchase Order.
INSPECTION AND ACCEPTANCE CRITERIA:
Deliverables described in Section D will be reviewed by the COR within 30 days of receipt. The work will be evaluated based on satisfactory performance of the tasks required in the Statement of Work. Acceptance will be based on tasks performed (as described in task reports) and suitability of related charges. The Contractor shall be notified as to the acceptability of the deliverables.
PAYMENT:
Payment shall be made upon receipt and acceptance of each deliverable. Payment authorization requires submission and approval of a progress report and an invoice per the Invoice & Payment Provisions in the Purchase Order.
This laboratory service is provided by Lentigen Technology, Inc. Lentigen Technology, Inc. is the only known source that can generate a retroviral producer cell line that can be used by the POB for pre-clinical studies, as well as to create a master cell bank for clinical studies at the same time, using a technology that insures GMP-grade manufacture and FDA compliance of the producer line, which is required for future clinical studies. There is no other viable option available to the POB in order to advance its scientific mission in such a cost efficient manner.
This notice is not a request for competitive quotation. However, if any interested party, especially small businesses, believes it can meet the above requirement, it may submit a capability statement, proposal, or quotation, which shall be considered by the agency. The statement of capabilities and any other information furnished must be in writing and must contain material in sufficient detail to allow the NCI to determine if the party can perform the requirement. Responses must be received in the contracting office by 1:00PM EDT, on July 11, 2016. All responses and questions must be in writing and faxed (240) 276-5401 or emailed to Catherine Muir, Contracting Officer via electronic mail at muirca@mail.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. No collect calls will be accepted. In order to receive an award, Contractors must be registered and have valid, current Entity Record, including current Representations and Certifications, in the System for Award Management (SAM) through SAM.gov. Reference: N02RC62614-76 on all correspondence
