SOLICITATION NOTICE
A -- Manufacture under cGMP specification of lots of DNA vaccine plasmids for Puumala virus PUUV or Hantaan virus HTNV or Venezuelan equine encephalitis virus VEEV plasmid DNA vaccines
- Notice Date
- 5/14/2009
- Notice Type
- Combined Synopsis/Solicitation
- NAICS
- 423490
— Other Professional Equipment and Supplies Merchant Wholesalers
- Contracting Office
- Department of the Army, U.S. Army Medical Research Acquisition Activity, U.S. Army Medical Research Acquisition Activity, US Army Medical Research Acquisition Activity, ATTN: MCMR-AAA, 820 Chandler Street, Frederick, MD 21702-5014
- ZIP Code
- 21702-5014
- Solicitation Number
- W81XWH09T0282
- Response Due
- 6/1/2009
- Archive Date
- 7/31/2009
- Point of Contact
- kevin comegys, 301-619-1128<br />
- Small Business Set-Aside
- N/A
- Description
- The U. S. Army Medical Research Institute of Infectious Diseases USAMRIID requires manufacture under cGMP specification of lots of DNA vaccine plasmids for Puumala virus PUUV or Hantaan virus HTNV or Venezuelan equine encephalitis virus VEEV plasmid DNA vaccines. Contract performance period shall be initiated and 3, 6, and 9 month timepoints conducted in the base year period. Deliverables for this program include a stability protocol and test reports. Option years will be exercised to conduct the remaining testing for 4 additional options periods. Option Year 1 will include the storage and testing of the 12 and 18 month timepoints. Option Year 2 will include the storage and testing of the 24 month time point. Option Year 3 will include the storage and testing of the 36 month time point. Option Year 4 will include the storage and testing of the 48 month time point. Any remaining material shipments not to exceed 3 may be made at the close of the last option period. This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in Subpart 12.6, as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; proposals are being requested and a written solicitation will not be issued. This is a request for proposal RFP and the solicitation document and incorporated provisions and clauses are thus in effect through Federal Acquisition Circular 90-46. The Statement of Work is as follows: USAMRIID requires manufacture under cGMP specification of lots of DNA vaccine plasmids for Puumala virus PUUV or Hantaan virus HTNV or Venezuelan equine encephalitis virus VEEV plasmid DNA vaccines. Work will be performed under contract should include a Re-Testing of existing Master Cell Bank MCB for HTNV Plasmid DNA Vaccine pWRG/HTN-M x, b Establishment of Manufacturers Working Cell Bank MWCB for HTNV plasmid, c Characterization of MWCB for HTNV plasmid, d Re-testing of the existing MWCB for PUUV plasmid DNA Vaccine pWRG/PUU-M s2, e Establishment and characterization of MCB for VEEV to include gel/restriction analysis and full sequence, f establishment and characterization of MWCB for VEEV g Process Optimization & Non-GMP Production of a plasmid DNA vaccine lot for each virus, f cGMP Production and Characterization of a Plasmid DNA greater than 3 g, 2 mg/ml lot for HTNV and PUUV and greater than 5 g, 2mg/ml for VEEV, g cGMP Formulation and Fill Finish of HTNV, PUUV, and VEEV Plasmid DNA Vaccines Drug Products, h Product Stability Program as detailed in Attachment 3, (i) Packaging and Shipment of Drug Products 6 SHIPMENTS, 2 for each product, j Final Filled or Bulk Drug Product Storage. Production of cGMP plasmid DNA bulk drug substance must provide at least 3 g DNA of HTNV and at least 3 g DNA of PUUV and at least 5 g DNA of VEEV at 2 mg/ml for each plasmid vaccine. cGMP formulation/fill must provide not less than 1500 vials at 2 mg/ml with 1 ml recoverable from each vial. Anticipated processes and sub-processes described in Attachment 1 are for information only. Contractor should submit a proposed best practice for achieving required deliverables as part of submission. Deliverables requested are (1) a Working cell bank for HTNV, (2) a Master cell bank for VEEV, (3) a Working cell bank for VEEV,(4) a pilot lot of DNA for each plasmid; (5) a cGMP final filled product lot of DNA for each plasmid; and (6) all documents (e.g., stability protocol, batch records, data records and reports, CoAs, BMF letter of cross reference) as required for submission to FDA or otherwise outlined in the Quality Agreement (Attachment 2). The product should meet the specifications (Attachment 1) and be in accordance with the negotiated Quality Agreement (Attachment 2). Selection criteria: Technical criteria: - Capable of manufacture and fill finish operations for plasmid DNA vaccine materials. "List of SOPs - Capable of process optimization and product storage to FDA specifications. - Capable of performing FDA-required testing (release and stability phases) for DNA candidate medical products. Management criteria: - Capable of managing all operations in compliance with FDAs current Good Manufacturing Practices. (cGMP). - Capable of documentation management and records management for candidate medical products as required for submission to FDA. - Established processes for quality control, quality assurance, regulatory compliance and change management. Past performance criteria: - Past performance on previous government contracts. - Past performance producing candidate medical products under cGMP compliance. - Past performance with production of DNA vaccine candidate products. -Successful FDA and state (if applicable) regulatory inspections. Contractors will be evaluated on the above 1) Technical Criteria 2) Management Criteria 3) Past Performance, and 4) Pricing. Factors are listed in descending order of importance.
- Web Link
-
FedBizOpps Complete View
(https://www.fbo.gov/spg/USA/USAMRAA/DAMD17/W81XWH09T0282/listing.html)
- Place of Performance
- Address: US Army Medical Research Acquisition Activity ATTN: MCMR-AAA, 820 Chandler Street Frederick MD<br />
- Zip Code: 21702-5014<br />
- Zip Code: 21702-5014<br />
- Record
- SN01816961-W 20090516/090514215918-ef92f242f658b71cef593af5d7ab14c7 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
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