Solicitation Title:
Medical Countermeasure Systems - Joint Vaccine Acquisition Program (MCS-JVAP) REQUEST FOR INFORMATION for the Development of Western, Eastern, and Venezuelan Equine Encephalitis (WEVEE) virus vaccine manufacturing.

Synopsis:
This is a Request for Information (RFI) for planning purposes only, as defined in FAR 15.201e. This is not a solicitation for proposals. Responses to this notice are not offers and cannot be accepted by the Government to form a binding contract. It is not to be construed as a commitment by the Government nor will the Government pay for the information solicited. No solicitation document exists or is guaranteed to be issued as a result of this RFI. Respondents are advised that the Government is under no obligation to acknowledge receipt of the information received or provide feedback to respondents with respect to any information submitted.

Background:
The Medical Countermeasure Systems - Joint Vaccine Acquisition Program (MCS-JVAP), previously known as the Chemical Biological Medical Systems (CBMS)-JVAP, is the advanced developer for the Department of Defense (DoD) and is responsible for developing, producing and stockpiling FDA-licensed vaccines to protect the Warfighter from biological agents. The current MCS-JVAP portfolio includes vaccines at varying stages of clinical development in addition to Food and Drug Administration (FDA) licensed vaccines.

Requirement:
MCS-JVAP has a requirement for a pre-exposure prophylaxis vaccine that provides protection against WEVEE viruses.

Purpose and Objectives: The primary objective of issuing this Request for Information (RFI) is to gather information that will assist in determining a suitable solution to efficiently, effectively, and economically provide process development, formulation development, assay development, and current Good Manufacturing Practices (cGMP)-compliant manufacturing of a mammalian-based vaccine under Biosafety level 3 (BSL-3) conditions suitable for non-clinical and Phase 1 clinical trials under an Investigational New Drug (IND) application.

Specifically, please describe your company's current (or ability by 1QFY15)in-house capabilities/facilities and experience in the areas listed below. If the current capability does not exist for one or more of the areas, please note when it will be available.
A. Process Development:
i. Current utilization of Quality by Design principles for the identification of critical manufacturing quality attributes and process parameters in biologics development
ii. Identification, selection and development of cGMP master and working cell banks
iii. Optimization of adherent or suspension cell lines and use of microcarriers
iv. Optimization of electroporation or transient transfection
v. Stable cell line generation
vi. Optimization of downstream purification to include tangential flow filtration (TFF), chromatography (ion exchange, size exclusion, affinity, mixed-mode etc.), centrifugation, bulk filtration or other clarification steps for multiple antigens
vii. Technology Transfer procedures
B. Formulation Development:
i. Optimization of product formulation to enhance stability and improve immune response
ii. International Conference on Harmonisation (ICH) compliant stability testing
C. Assay Development:
i. Development of analytical assays to include in-process and lot release assays for cGMP bulk and final product
D. BSL-3 cGMP Manufacturing
i. BSL-3 manufacturing capability, capacity (bioreactor volume etc.), and availability
ii. Manufacturing material (BSL-2 or BSL-3) released for clinical use and the clinical phase(s) for which the material was manufactured
E. Fill Finish Capability
F. Regulatory Support
i. Overarching quality assurance program and the integration of quality assurance into process development and cGMP manufacturing efforts
ii. Dates of past FDA facility audits, including preapproval inspections and resolution of form 483 inspection observations
iii. Ability and experience working with the Food and Drug Administration
iv. Preparing Chemistry Manufacturing and Controls (CMC) regulatory submissions to support INDs and Biologics License Applications (BLAs) in electronic Common Technical Document (eCTD) format
v. Participation in FDA meetings
G. General
i. Company business size (based on the NAICS size standard, business status (i.e., large business, small business, disadvantaged, service-disabled veteran-owned small business, etc.) and date of incorporation
ii. Management of quality systems
iii. Program management structure
iv. Subcontractor management
v. Length of time similar services have been provided
vi. DoD experience
vii. Customer service capability

The Government will retain comments and information received in response to this RFI. Proprietary information should be identified as Company Proprietary. Do not use Government Security classification markings.

Questions regarding this RFI should be forwarded to the MCS e-mail address listed below within 15 days after RFI release.

Submission Instructions:

All written responses must be received no later than 20 September 2013. Submissions should: (1) use Microsoft Word or Adobe Portable Document Format (PDF); (2) be sent to [email protected]; (3) be minimum 11 font on 8.5 X 11 paper; (4) be complete, sufficiently detailed, and organized in a manner that tracks to the information requested in this RFI; (5) include a single company point of contact with name, title, address, telephone and fax numbers, and e-mail address(es); and (6) not exceed 20 single sided pages in total (not including cover page and cover letter). Other media types (i.e. CD, printed technical information) that meet the submission criteria above will be accepted and should be sent to the Point of Contact at the Contracting Office Address provided below.



Point of Contact(s):
[email protected]
Contracting Office Address:
ACC-APG NCD
ATTN: Nathan Jordan
1564 Freedman Drive
Fort Detrick, MD 21702
Place of Performance:
ACC-APG NCD
ATTN: Nathan Jordan
1564 Freedman Drive
Fort Detrick, MD 21702
Point of Contact(s):
Nathan Jordan, 508-233-6169
[email protected]

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