Sources Sought notice for commercial entities with the capabilities to perform technical transfer, validation of sterile formulation, fill-finish and release of two recombinant protein aliminum-adjuvanted vaccines.
SYNOPSIS
This is a Sources Sought notice posted by the ACC-APG-Natick Contracting Office on behalf of a contract awardee. This posting and any subsequent action is not directly governed by ACC-APG or the contract customer, MCS-JVAP. This is NOT a solicitation for proposals, proposal abstracts, or quotations. The purpose of this notice is to obtain information regarding the availability and capability of all qualified sources to perform a potential requirement. This notice is issued to help determine the availability of qualified companies technically capable of meeting the Government requirement and to determine the method of acquisition. It is not to be construed as a commitment by the Government to issue a solicitation or ultimately award a contract. Responses will not be considered as proposals or quotes. No award will be made as a result of this notice. The Government will NOT be responsible for any costs incurred by the respondents to this notice. This notice is strictly for research and information purposes only.
PROJECT REQUIREMENTS
ACC-APG Natick contracting is posting this notice on behalf of DynPort Vaccine Company LLC (DVC), A CSC Company. DVC is seeking interest by commercial entities with the capabilities to perform technical transfer, validation of sterile formulation, fill-finish and release of two recombinant protein aluminium-adjuvanted vaccines are being sought. The capability to manufacture individual batches of at least 100,000 single dose vials, of approximately 1 mL fill volume in 3 mL/13 mm glass vials is desirable.
DVC is seeking the technical services of a Subcontractor that will be responsible for:
1.1. Technical transfer and validation of formulation, filling, and finish process for two recombinant adjuvanted vaccines. Each batch will target the filling of at least 100,000 single dose vials, of approximately 1 mL fill volume in 3 mL/13 mm glass vials.
1.2. Technical transfer and validation of release and stability assays for each drug product, including gel blot and HPLC based assays.
1.3. Stability testing of both lots
1.4. Aseptic demonstration by media challenges of a formulation and filling process to cover both the rBV and rF1V drug products
1.5. Evaluate process improvements to reduce the risk of glass delamination and the incidence of visible particulate formation in the filled drug products
1.6. Demonstration of drug product comparability for rBV A/B
1.7. Independent audit for PAI readiness prior to PAI
Respondents to this notice must provide, as part of their response, a capability statement that includes, clear and convincing documentation of their capability of providing the requirement as specified in this notice.
The North American Industry Classification Systems (NAICS) code for this notice is 325414, Biological Product (except Diagnostic) Manufacturing (with a size standard of 500 employees).
The respondent must also provide their DUNS number, organization name, address, point of contact, and size and type of business (e.g., large business, small business, small disadvantaged business, etc.) pursuant to the applicable NAICS code and any other information that may be helpful in developing or finalizing the acquisition requirements.
Responses must be in Microsoft Word, Portable Document Format, or MS Power Point formats. Preferred media is electronic. Material that is advertisement only in nature is not desired. All responses to this notice must be submitted electronically to Allison Jones, DVC, Sr. Professional, Contracts & Commercial Mgmt, at [email protected]
The response must be received on or before Friday, May 23, 2014 at 4pm Eastern Standard Time.
DVC, will retain comments and information received in response to this notice. Proprietary information should be identified as Company Proprietary. Do not use Government Security Classification markings. Any information provided in response to this sources sought notice is for planning purposes only and will not be used as a selection consideration factor in any U.S. Government contract competition. This Sources Sought Notice allows qualified sources for this requirement to self-identify. No solicitation document exists or is guaranteed to be issued as a result of this notice.
DVC Office Address:
DynPort Vaccine Company, LLC, a CSC Company (DVC)
64 Thomas Johnson Drive
Frederick, MD 21702
Primary Point of Contact:
Allison Jones, Sr. Professional, Contracts & Commercial Mgmt
[email protected]
(301) 607-5263 Office
Jessica Ely, 301-619-8457
ACC-APG - Natick (SPS)
