SOLICITATION NOTICE
65 -- Production of Master Virus Bank & Clinical Lot
- Notice Date
- 12/16/2009
- Notice Type
- Presolicitation
- NAICS
- 541690
— Other Scientific and Technical Consulting Services
- Contracting Office
- Department of Health and Human Services, National Institutes of Health, National Cancer Institute, Office of Acquisitions, 6120 Executive Blvd., EPS Suite 600, Rockville, Maryland, 20852
- ZIP Code
- 20852
- Solicitation Number
- NCI-100033-MM
- Archive Date
- 1/12/2010
- Point of Contact
- Melissa P Marino, Phone: 301-402-4509, Caren N Rasmussen, Phone: (301) 402-4509
- E-Mail Address
-
marinome@mail.nih.gov, cr214i@nih.gov
(marinome@mail.nih.gov, cr214i@nih.gov)
- Small Business Set-Aside
- N/A
- Description
- Contracting Office Address Department of Health and Human Services, National Institutes of Health, National Cancer Institute, Office of Acquisitions, 6120 Executive Boulevard, EPS Suite 600, Room 6072, Rockville, MD 20852, UNITED STATES. Description The National Cancer Institute (NCI), Center for Cancer Research (CCR), Vaccine Branch, plans to procure on a sole source basis with Baylor College of Medicine, 1102 Bates St., Suite 1120, Houston, Texas 77030 for production of a master virus bank and clinical lot with one additional option clinical lot. 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 acquisitions. Only one award will be made as a result of this solicitation. This will be awarded as a firm fixed price type contract. Period of performance shall be for twelve months from date of award. The Vaccine Branch of the CCR at the NCI is engaged in the study of novel vaccine platforms and immune-based therapies that harness the immune response to control, eradicate or prevent cancer and HIV infection. The purpose of this contract is to acquire cGMP adenoviral vector expressing the human HER2/neu oncogene for use in therapeutic cancer vaccine trials. These trials will allow evaluation of vaccine immunogenicity and the ability of vaccine-induced immune responses to eradicate, reduce or stabilize cancers expressing HER2/neu, specifically breast cancer. For this project, a total of 7 x 1013 to 1.2 x 1014 total viral particles of clinical grade recombinant adenoviral Ad5f35 vector expressing the extracellular (EC) and transmembrane (TM) portions components of the human HER2/neu oncogene will be required for initial clinical studies. An additional clinical lot of 7 x 1013 to 1.2 x 1014 total viral particles will be generated for future clinical trials utilizing this vector. This adenoviral vector must be produced under current Good Manufacturing Practice (cGMP) guidelines in accordance with the CGMP Regulations outlined in 21CFR Parts 210 and 211, in its manufacture and testing as required by the FDA to permit its investigational use in human subjects. Vector manufacture will include sequence verification, testing for lot toxicity, stability and quality control, and certification of analysis according to Standard Operating Procedures (SOPs) as outlined in the Statement of Work. In addition, all other Chemistry, Manufacturing and Control (CMC) documentation required for IND filing with the FDA is to be provided. Baylor College of Medicine is the only known source capable of providing the combination of resources required for the project.Baylor College of Medicine has developed the recombinant Ad5f35 vector and has extensive experience in specifically generating this type of recombinant vector under cGMP conditions. The Ad5f35 vectors generated by Baylor College of Medicine have targeted several different oncogenes and been investigated in multiple clinical trials for different types of cancer. The reason a recombinant Ad5f35 vector is required is because this type of vector: a)permits a high transduction efficiency of human B cells and dendritic cells, thereby ensuring greater expression of the HER2/neu oncogene. b)makes gene expression less susceptible to neutralization by pre-existing antibodies to Ad5 in patients undergoing treatment with platforms utilizing the Ad5f35 recombinant vector. Baylor College of Medicine is the only known source that has extensive experience with this Ad5f35 vector. Baylor College of Medicine also made the pre-clinical grade Ad5f35 recombinant vector expressing the extracellular and transmembrane domains of human HER2/neu, which the Center for Cancer Research has tested and found to have an excellent expression level. Baylor College will be using these vectors to generate the Master Virus Bank as requested in the current requirement. Use of the recombinant Ad5f35 vector will maximize expression of HER2/neu ECTM and in turn the immunogenicity of the vaccine platform. HER2/neu oncogene expression is associated with high recurrence rates and reduced survival following standard treatment.. Importantly, vaccines that elicit antibodies targeting HER2/neu are currently not available. The production of adenoviral vectors for clinical applications requires a multitude of steps all of which are subject to failure. The Center for Cell and Gene Therapy at Baylor College of Medicine has developed a rigorous series of safety testing protocols (QC/QA) that minimize production failures. The development of effective alternative treatments as well as treatments that can be combined to enhance the efficacy of current treatment is critical. For the foregoing reasons, the Center for Cell and Gene Therapy, Baylor College of Medicine-BCM is the only known facility that is capable of supplying the adenoviral vector needed to carry out these trials. This is not a solicitation for competitive quotations. However, if any interested party 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 contracting office on or before 11:00 AM EST on December 28, 2009. 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 to the address stated above. All questions must be in writing and can be faxed (301) 402-4513 or emailed to Melissa Marino, Contract Specialist at marinome@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) www.ccr.gov and the Online Representations and Certifications Applications (ORCA), http://orca.bpn.gov. No collect calls will be accepted. Please reference solicitation number NCI-100033-MM on all correspondences.
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