Loren Data's SAM Daily™

FBO DAILY ISSUE OF JUNE 09, 2011 FBO #3484
SOLICITATION NOTICE

A -- Delivery of a current Good Manufacturing Practices (cGMP) trivalent filovirus vaccine using the Venezuelan Equine Encephalitis (VEE) Replicon Particle (VRP) system

Notice Date

6/7/2011
 

Notice Type

Presolicitation
 

NAICS

541711 — Research and Development in Biotechnology
 

Contracting Office

ACC-APG SCRT - Natick (SPS), ATTN: AMSRD-ACC-N, Natick Contracting Division (R and BaseOPS), Building 1, Kansas Street, Natick, MA 01760-5011
 

ZIP Code

01760-5011
 

Solicitation Number

W911QY-11-R-0039
 

Response Due

6/22/2011
 

Archive Date

8/21/2011
 

Point of Contact

Lawrence Mize, 301-619-9813
 

E-Mail Address

ACC-APG SCRT - Natick (SPS)
(lawrence.mize@us.army.mil)
 

Small Business Set-Aside

N/A
 

Description

Pre-Solicitation Notice The U.S. Army Contracting Command Aberdeen Proving Grounds (ACC-APG) Natick Division is providing notice that a Request for Proposal (RFP), W911QY-11-R-0039, for the delivery of a current Good Manufacturing Practices (cGMP) trivalent filovirus vaccine using the Venezuelan Equine Encephalitis (VEE) Replicon Particle (VRP) system will be issued on or about 22 June 2011 with an anticipated contract award on or about 18 October 2011. This is a full and open competition and all responsible or qualified sources are eligible to compete. In accordance with DFARS 252.204-7004, all interested contractors shall be registered in the Central Contractor Registration (CCR) database. CCR registration can be accomplished at the following website: http://www.ccr.gov. The North American Industry Classification System (NAICS) codes for this procurement are 541711, Research and Development in Biotechnology. The Government does not intend to use FAR Part 12 for this acquisition. The Government intends to serve as the regulatory sponsor and system integrator for this effort. The objective of this procurement is to deliver, after limited advance development, a current Good Manufacturing Practices (cGMP) trivalent filovirus vaccine using the Government Licensed Venezuelan Equine Encephalitis (VEE) Replicon Particle (VRP) system that will be suitable/acceptable for use in humans by the Government to support non-clinical and Phase 1 studies under an Investigational New Drug (IND) application. The manufacturer shall develop, abide by and document cGMP and processes consistent with the International Conference on Harmonisation (ICH) Q7 guidelines on Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients, FDA regulation 21 CFR Part 211-cGMP for Finished Pharmaceuticals, and 21 CFR Part 600. In addition to delivering a cGMP final vaccine product to support clinical and nonclinical efforts, the Contractor shall conduct formulation studies to support the development of a trivalent vaccine as well as analytical assay development, including in-process and release assays of cGMP bulk(s) and final product, and International Conference on Harmonization (ICH)-compliant stability testing. The small scale manufacturing process developed must be scalable and transferrable to another facility, if necessary. The viral glycoprotein genes from each strain shall be cloned into a cGMP compliant optimized VEE replicon vector. The replicon technology is derived from an attenuated strain of the VEE virus, V3014. Specific pathogen genes of interest are inserted as replacements for VEE virus structural genes, thereby making the particle replication defective. Note: The initial manufacturing efforts must be conducted at BioSafety Level (BSL) 3. Downstream processing can occur at BSL-2 following negative testing results for live virus. Proposals will be evaluated based on Factors, Subfactors, and Elements representing the "Best Value" to the Government. Delivery schedules of the vaccine product shall be proposed by the offerors and will be used as one of the criteria associated with a Best Value evaluation. Proposed schedule calling for delivery of the Trivalent Filovirus Vaccine, as described above, is anticipated within 3 to 4 years after contract award, but all proposed delivery schedules will be evaluated. All interested parties can view, download, and print a copy of the solicitation and any resulting amendments when released on or about 22 June 2011 at the FedBizOpps website hyperlink https://www.fbo.gov/. Search on solicitation number W911QY-11-R-0039. No paper copies of the RFP will be provided and no mailing list will be maintained because the acquisition will be posted on the above website. Questions or correspondence should be directed by e-mail to cbmsfilorfp@amedd.army.mil and please reference the RFP number W911QY-11-R-0039. Contracting Office Address: The U.S. Army Contracting Command Aberdeen Proving Grounds (ACC-APG) Natick Division, 64 Thomas Johnson Drive, Frederick, MD 21702 Point of Contact(s): Lawrence Mize, lawrence.mize@us.army.mil
 

Web Link

FBO.gov Permalink
(https://www.fbo.gov/notices/d2ea96a15d6ba65795c0c45994e34817)
 

Place of Performance

Address: Army Contracting Command Aberdeen Proving Grounds (ACC-APG) Natick Division 64 Thomas Johnson Frederick MD

Zip Code: 21702
 

Record

SN02465661-W 20110609/110607234500-d2ea96a15d6ba65795c0c45994e34817 (fbodaily.com)
 

Source

FedBizOpps Link to This Notice
(may not be valid after Archive Date)

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