Sources Sought Notice – A– Medical Countermeasures Systems – Joint Vaccine Acquisition Program (MCS-JVAP) REQUEST FOR INFORMATION for the manufacturing of recombinant botulinum neurotoxin serotypes A and B vaccine.

Sources Sought Notice - A-- Medical Countermeasures Systems - Joint Vaccine Acquisition Program (MCS-JVAP) REQUEST FOR INFORMATION for the manufacturing of recombinant botulinum neurotoxin serotypes A and B vaccine.

Notice Type: Sources Sought Notice

Posted Date: 27-SEP-13

Office Address: Department of the Army; Army Contracting Command; ACC-APG - Natick (SPS); ATTN: AMSRD-ACC-N, Natick Contracting Division (R and BaseOPS), Building 1, Kansas Street, Natick, MA 01760-5011

Subject: A-- Medical Countermeasures Systems - Joint Vaccine Acquisition Program (MCS-JVAP) REQUEST FOR INFORMATION for the manufacturing of recombinant botulinum neurotoxin serotypes A and B vaccine.

Classification Code: A - Research & Development

Solicitation Number: W911QY-13-CMORFI

Contact: Jessica Ely, 301-619-8457 mailto:[email protected] [ACC-APG - Natick (SPS)]

Setaside: N/AN/A

Place of Performance (address): ACC-APG - Natick (Frederick Office) ATTN: Jessica Ely, 110 Thomas Johnson Drive Frederick MD

Place of Performance (zipcode): 21702

Place of Performance Country: US

Description: Department of the Army

Army Contracting Command

ACC-APG - Natick (SPS)

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) 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 AdministrationFDA licensed vaccine. Currently, large scale process validations are complete for both drug substances. Specifically, please described your company's current and/or future in-house capabilities/facilities and experience in the areas listed below. If the current manufacturing capability does not exist within your facilities, please note when it will be available and at what capacity. A. Technology Transfer: i. Experience in technology transfer of a cGMP manufacturing process from other customers or facilities (Please provide a brief description of historical data to include the number of process transferred to your facility, approximate date of last activity and describe any formal technology transfer strategy/plan if one exists) ii. Identification of critical manufacturing quality attributes and ability to employ Quality by Design principles (Specifically, the assessment of incoming processes, the need for process changes to match suitability requirements of your facility and the overall impact those changes may have on the licensure process.) iii. Importation and adaptation of upstream and downstream cGMP process iv. Experience in process validation to include the average rate at which transferred cGMP manufacturing process are validated within your facility(ies) v. Importation and adaptation of analytical assays to include in-process and lot release assays for cGMP bulk and purified product B. cGMP Manufacturing i. cGMP manufacturing capability and capacity, including Pichia fermentation equipment available for immediate manufacturing of this drug substance (please provide the physical attributes at your facility), ability to conduct simultaneous manufacturing, and current operational status (If such equipment is or is not already onsite and operational, please elaborate as to when it might be and when it will be operational.) ii. Manufacturing efforts performed in-house and those subcontracted. If subcontractors were used, describe what percentage of the work was outsourced to subcontractors iii. Experience manufacturing clinical material and the clinical phase(s) for which the material was manufactured iv. Success rate for cGMP Pichia fermentation operations at the facility(ies) v. Capability and available control systems for Pichia fermentation, including but not limited to dissolved oxygen, methanol feed, temperature and pH control systems and scale(s) available vi. Downstream purification to include, chromatography (hydrophobic interaction, ion exchange, size exclusion, mixed-mode etc.), centrifugation, bulk filtration or other clarification steps for multiple antigens vii. Approach for testing and releasing raw materials for all tests/processes viii. Capacity to implement a stability program for testing of bulk drug substances and purified drug products ix. Project managers/leads with Pichia experience, number of years experience/number of products they have worked on C. Quality Systems i. Management of quality systems and the number of Quality Assurance employees ii. Average duration of QA approval and release of batch production records, and certificate of acceptance iii. Experience in pharmaceutical Quality Management Systems in relation to ICH Q8/ Q9/ Q10/ Q11. iv. Experience in managing analytical assays, such as in-process and lot release assays, for cGMP bulk and purified product v. Approach and methodology to technical risk management with a focus on technology transfer vi. Approach to route cause analysis and implementation of findings D. Regulatory Support i. Ability and experience working with the Food and Drug Administration ii. Preparing Chemistry Manufacturing and Controls (CMC) regulatory submissions to support INDs and Biologics License Applications (BLAs) iii. Participation in FDA meetings iv. Previous FDA audits E. General i. Current and future availability of cGMP and project management resources ii. Experience in writing detailed reports and in providing recommendations for process improvements iii. Experience in working with Government contracts, if so type of contract used (fixed price or cost-type). If not, please indicate your level of interest in contracting directly with the Government and the desired contract type iv. Experience working on contracts with Earned Value Management (EVM) requirements v. Does your company have Defense Contract Audit Agency accepted accounting, estimating, purchasing, and EVM systems 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 contract specialist e-mail address listed below within 10 days after RFI release. Submission Instructions: All written responses must be received no later than October 16, 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 30 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 Army Contracting Command - Aberdeen Proving Ground (ACC-APG), ATTN: Jessica Ely, 110 Thomas Johnson Drive, Frederick, Maryland 21702. Material that is advertisement only in nature is not desired. The attached document can be used for submittal of information, if needed, but is not required.

Link/URL: https://www.fbo.gov/notices/ed2c0bc8410ee6f2631a40be6bd3884c