SOLICITATION NOTICE
A -- CMV-MVA Virus in preparation for GMP Production - S10-142
- Notice Date
- 4/2/2010
- Notice Type
- Combined Synopsis/Solicitation
- NAICS
- 541711
— Research and Development in Biotechnology
- Contracting Office
- Department of Health and Human Services, National Institutes of Health, National Cancer Institute, Bldg 427, Room 12, Frederick, Maryland, 21702
- ZIP Code
- 21702
- Solicitation Number
- S10-142
- Archive Date
- 5/20/2010
- Point of Contact
- Howard R. Souder, Jr., Phone: 3018465096
- E-Mail Address
-
souderhr@mail.nih.gov
(souderhr@mail.nih.gov)
- Small Business Set-Aside
- N/A
- Description
- PROCESS DEVELOPMENT STUDIES WITH CMV-MVA VIRUS IN PREPARATION FOR GMP PRODUCTION. PROJECT TITLE: PROCESS DEVELOPMENT STUDIES WITH CMV-MVA VIRUS IN PREPARATION FOR GMP PRODUCTION. OBJECTIVES: 1. Transfer the CMV-MVA seed virus and all available handling and characterization protocols. 2. Obtain the required materials for development studies. 3. Conduct experiments to establish optimal virus expansion procedures. 4. Deliver required documentation to support the selection of optimal virus expansion conditions and predictions for large scale production. 5. Provide the technical scope, schedule and budget requirements for an option to complete GMP production of virus for Phase I/II clinical studies. Additional Information: Subcontract award is contingent on the facilities, operations and staff qualification to perform large scale GMP manufacturing (such as roller bottle culture capacity, Wave TM bioreactor or equivalent platforms) to support the production and purification of CMV-MVA for phase 1 clinical studies. Expected period of performance is 3 months from project initiation. DELIVERABLES: UPON COMPLETION OF THE PROJECT, THE SUBCONTRATOR WILL DELIVER TO SAIC-F THE FOLLOWING ITEMS: A. A technical report summarizing the studies conducted and results obtained. B. A scope and budget to conduct the production and purification of clinical-grade CMV-MVA virus total of at least 3 x 1011pfu. The production of expanded virus should be in a single batch such as 50 roller bottles, 100L Wave TM bioreactor or equivalent. STARTING MATERIALS: A. Identification: Plaque purified CMV-MVA Virus Seed. pp65-IEfusion-MVA Large Scale Expansion Batch #: 0034-90-0001 ID: F8 B. Source: SAIC-Frederick, Inc. or specified contractor. C. Characteristics: - Produced in Chicken Embryonic Fibroblasts (CEF). - Identity confirmed by PCR analysis and sequencing of the transgenes. - Infectivity/Potency (1.95 x 108pfu/mL) determined by plaque assay on CEF cells. - Tested free of bioburden and mycoplasma. - Expression of CMV IEfusion and pp65 proteins confirmed by Western Blot following infection of susceptible cells. D. Materials Disposal: Subcontractor will retain any remaining starting materials and in-process samples until the final report is mailed and deliverables are acquired. The remainder will then be returned to SAIC-F or discarded, as determined by SAIC-F. Milestone 1 - PROCESS DEVELOPMENT STUDIES Description: Starting materials and handling/testing protocols are transferred to the Subcontractor. The Subcontractor will acquire the appropriate cell substrate to be used to produce the product. The Subcontractor will perform feasibility experiment(s) to determine and optimize virus productivity. Variables that may be investigated include cell handling parameters, cell density at infection, multiplicity of infection (MOI), temperature of infection, and duration of infection. Other variables may be considered in consultation with SAIC-F COTR. Experiments must be designed and conducted in a way to select optimal conditions for further manufacturing and to predict virus yield. Milestone 2 - PROJECT CLOSEOUT Description: The Subcontractor and SAIC-F shall complete internal procedures to effectively and satisfactorily complete the contract, including transfer of all deliverables, appropriate disposition of all in-process by-products, and preparation and closeout of all final documentation.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/NIH/FCRF/S10-142/listing.html)
- Record
- SN02111402-W 20100404/100402235158-7a856cc79f9338c052893c856dfabfaa (fbodaily.com)
- Source
-
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