SPECIAL NOTICE
A -- Request for Information - Plasmid DNA Manufacture
- Notice Date
- 3/16/2018
- Notice Type
- Synopsis
- NAICS
- 541714
— Research and Development in Biotechnology (except Nanobiotechnology)
- Contracting Office
- Attn: MCMR-AAA 820 Chandler Street Frederick, MD 21702-5014 MD 21702-5014
- ZIP Code
- 21702-5014
- Solicitation Number
- W81XWH-18-RFI-DNA
- Response Due
- 4/16/2018
- Point of Contact
- Dana M. Kavitski
- E-Mail Address
-
dana.kavitski.civ@mail.mil
- Small Business Set-Aside
- N/A
- Description
- 1.0 RFI TITLE: Plasmid DNA Manufacture 2.0 AGENCY: Army 3.0 OFFICE: US Army Medical Research Institute of Infectious Diseases 4.0 LOCATION: Fort Detrick, Frederick, MD 21702 5.0 SUBJECT/BACKGROUND: Two plasmid DNA vaccines expressing genes from Hantaan virus or Puumala virus have previously been manufactured and have both been tested in clinical studies. A Phase 1 study was performed to evaluate the individual and mixed DNA vaccines delivered by intramuscular electroporation and the results are published (Hooper, et al. 2014. Clin Microbiol Infect 20 Suppl 5: 110-117). After codon-optimizing the Hantaan virus DNA vaccine, additional cGMP lots were manufactured and a Phase 2a dose ranging study of the mixed vaccines was conducted in 120 subjects (unpublished results). The individual and mixed codon optimized DNAs were also tested in 26 subjects who were vaccinated using the PharmaJet Stratis jet injector (unpublished results). The DNA vaccines used in each of these studies were vialed separately and for subjects receiving both vaccines, the DNAs were mixed just prior to vaccination.. Additional lots of the DNA plasmids are required for larger scale clinical testing. Master seeds are available for both plasmids and would be available for transfer for manufacture of the DNA vaccines. 6.0 DISCLAIMER: This RFI is issued solely for information and planning purposes and does not constitute a solicitation. Neither unsolicited proposals nor any other kind of offers will be considered in response to this RFI. Responses to this notice are not offers and will not be accepted by the Government to form a binding contract. In keeping with the standards of FAR Part 10, the Government may request additional information from responders. Responders are solely responsible for all expenses associated with responding to this RFI or any follow-up information request. All information received in response to this RFI or any follow-up information request that is marked Proprietary will be handled accordingly. Responses to the RFI will not be returned. At this time, questions concerning the composition and requirements for a future request for proposal will not be entertained. 7.0 DESCRIPTION: Manufacture and fill finish of plasmid DNA vaccines 8.0 SUBMISSION INSTRUCTIONS: Two plasmid DNA vaccines expressing genes from Hantaan virus or Puumala virus have previously been manufactured and have both been tested in Phase 1 and Phase 2 clinical studies. Additional lots of the DNA plasmids are required for larger scale clinical testing. Master seeds are available for both plasmids and would be available for transfer for manufacture of the DNA vaccines. Three separate pricing estimates are requested:(1) 1,000 vials of cGMP DNA vaccine for Hantaan virus and 1,000 vials of cGMP DNA vaccine for Puumala virus at a concentration of 4 mg/ml in a total of 1.3 ml/vial; (2) 2,000 vials of cGMP DNA vaccines with a 1:1 mixture of the Hantaan virus:Puumala virus DNA vaccines at a concentration of 4 mg/ml (2 mg/ml each DNA) in a total of 1.3 ml/vial; (3) ) 2,000 vials of cGMP DNA vaccines with a 1:1 mixture of the Hantaan virus:Puumala virus DNA vaccines at a concentration of 6 mg/ml (3 mg/ml each DNA) in a total of 1.3 ml/vial. Pricing estimates to include release and stability testing. Entities interested in submitting a response must furnish a white paper addressing the above capability (maximum of five pages, not including cover page, index or list of references). The subject header of the email for submission of questions and/or the RFI response shall be: Hantavirus cGMP DNA Vaccines. All information regarding capabilities statements or any other proprietary information relative to this RFI shall be marked appropriately. Submission should include the following information: A description of similar work if any: An estimate of the projected cost; Responder's complete contact information (telephone, physical address, and email address). 9.0 SUBMISSION CONTACT INFORMATION: Interested entities shall forward submissions to Connie Schmaljohn, Ph.D. at Connie.s.schmaljohn.civ@mail.mil no later than 9:00am Eastern Time on 16 APRIL 2018. Telephonic communication will not be considered as submission nor receive response. NOTE: THIS NOTICE WAS NOT POSTED TO FEDBIZOPPS ON THE DATE INDICATED IN THE NOTICE ITSELF (16-MAR-2018); HOWEVER, IT DID APPEAR IN THE FEDBIZOPPS FTP FEED ON THIS DATE. PLEASE CONTACT 877-472-3779 or fbo.support@gsa.gov REGARDING THIS ISSUE.
- Web Link
-
Link To Document
(https://www.fbo.gov/spg/USA/USAMRAA/DAMD17/W81XWH-18-RFI-DNA/listing.html)
- Record
- SN04857615-F 20180318/180316230951 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
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