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This Sources Sought opportunity from Department Of Defense was posted on April 25, 2018. The submission period has ended. Browse the details below for market research, or find similar active opportunities.

Aluminum Adjuvanted Recombinant Vaccine Drug Product (DP) Formulation Evaluation, DP Process Development and Clinical/Commercial DP Formulation and Filling.

Closed
DVC0600-SS-18Federal

Contract Overview

Solicitation details, issuing organization, response deadlines, documents, and interested companies for this government contract opportunity.

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NAICS: 541715
New
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Solicitation # W911PT26SC001
The U.S. Army Contracting Command – Watervliet Arsenal (ACC-WVA) has issued solicitation W911PT26SC001, a Commercial Solutions Opening (CSO) authorized under the National Defense Authorization Act for Fiscal Year 2026 and DFARS Subpart 212.70. This competitive solicitation is open until September 30, 2027, and is designed to acquire innovative commercial products, technologies, and services to modernize the Army's Organic Industrial Base. The scope focuses on integrating manufacturing resources, linking legacy analogue systems with digital systems, and expanding modeling and simulation to enhance the delivery of materiel solutions. The CSO targets both traditional and non-traditional business entities, including small businesses and foreign-owned firms, provided they maintain an active System for Award Management (SAM) profile and a Unique Entity ID. The acquisition process follows a multi-phased approach consisting of a written solution brief, an optional presentation or pitch, and a final Request for Commercial Solution Proposal (CSP). Evaluation is based on responsiveness, technical merit, uniqueness, and price reasonableness. Successful responses may result in fixed-price contracts awarded under FAR Part 12 Commercial Item Procedures. Current Areas of Interest (AoIs) include advanced cannon technology, electrical infrastructure improvements at Building 120, chromium facility conversion, automated manufacturing for minor components, automated cooling tower treatments, advanced CNC vertical turning lathes, and advanced tooling for radial forging. Performance is primarily located at Watervliet Arsenal and Benet Laboratories, with a general period of performance not to exceed 12 months unless otherwise specified.
W6QK Acc Wva

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about 11 hours ago

DEADLINE

in 11 months
NAICS: 541715
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Coordinating Center for National Resource Network for the Study of Human Auditory and Vestibular Disorders (U24 Clinical Trial Not Allowed)
Solicitation # RFA-DC-28-002
Solicitation RFA-DC-28-002 is a Notice of Funding Opportunity from the National Institutes of Health, specifically the National Institute on Deafness and Other Communication Disorders, to establish a Coordinating Center for the NIDCD National Human Ear Resource Network. This collaborative network provides human inner and middle ear tissues to researchers for basic and clinical studies aimed at advancing the treatment of auditory and vestibular disorders. The Coordinating Center is responsible for maintaining network cohesiveness through the planning of workshops, symposia, and regular meetings, providing updates to laboratories, and managing communication with the public and scientific community regarding tissue donation. The maximum project period is five years, with a budget limit of 200,000 dollars in direct costs per year. Applicants, including for-profit organizations and small businesses, must maintain active registrations in SAM, eRA Commons, and Grants.gov. Proposals are evaluated based on the significance of the proposed center and the qualifications of the investigators, with additional reviews for human subject protections, inclusion policies, and the use of vertebrate animals. Key requirements include a structured Data Management and Sharing Plan and adherence to cybersecurity guidelines, including a 48-hour incident reporting window. The application process is entirely electronic and requires several standard PHS and SF424 forms, with a response deadline of March 5, 2027.
National Institutes Of Health

POSTED

about 19 hours ago

DEADLINE

in 5 months
NAICS: 541715
New
Grant
National Resource Network for the Study of Human Auditory and Vestibular Disorders (U24 Clinical Trial Not Allowed)
Solicitation # RFA-DC-28-001
Solicitation RFA-DC-28-001 is a Notice of Funding Opportunity issued by the National Institutes of Health under the Department of Health and Human Services to support the NIDCD National Human Ear Resource Network. The objective is to maintain a collaborative network of laboratories that serve as a national technological resource, providing human inner and middle ear tissues to researchers for basic and clinical studies to advance the treatment of auditory and vestibular disorders. The scope of work includes processing human temporal bones from the National Hearing and Balance Organ Donor Program, uploading images and medical data to EarBase, sharing gene-expression data via the gEAR repository, and providing technical instruction to increase the number of skilled researchers in the field. The NIDCD intends to commit 3.6 million dollars in FY 2028 to fund up to six awards, with a maximum project period of five years. Individual awards are limited to 450,000 dollars in direct costs per year, with an additional 150,000 dollars available for specific subawards. Applications are due on March 05, 2027, and November 01, 2027, with staggered start dates ranging from July 2027 to July 2028. Evaluation is based on the experience of the investigators, the adequacy of the institutional environment, and the protection of human subjects. Applicants must maintain active SAM registration and a Unique Entity Identifier, and they must provide a Data Management and Sharing Plan and a Material Transfer Agreement. Compliance with the Cybersecurity Act of 2015 is required, including the development of an incident response plan and notification of cybersecurity incidents within 48 hours of discovery.
National Institutes Of Health

POSTED

about 19 hours ago

DEADLINE

in about 1 year

General Info

NAICS

541715 - Research and Development in the Physical, Engineering, and Life Sciences (except Nanotechnology and Biotechnology)

Place of Performance

110 Thomas Johnson Drive, FREDERICK, MD, 21702, USA

Set-Aside

NONE

Documents

0

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Timeline

PhaseClosed
Posted

Sources Sought

Response Deadline

Deadline has passed

Submission Closed

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Organization & Contact Information

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AgencyDepartment Of Defense → W6QK Acc-Apg Natick
Contacts2 people available
OfficeNATICK, MA, 01760-5011, USA
Office AddressNATICK, MA, 01760-5011, USA
Contacts

Full Description

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DynPort Vaccine Company LLC, a General Dynamics Information Technology Company (DVC), a biopharmaceutical company in Frederick, Maryland, is issuing this Request for Information (RFI) to gain insight into the capabilities of potential industry partners in aluminum adjuvanted recombinant vaccine drug product (DP) formulation evaluation, DP process development and clinical/commercial cGMP DP manufacturing. These efforts will involve evaluating the current DP formulation, and investigating potential formulation/manufacturing process changes/improvements. Additionally, task may include incorporating the recommended procedures into the clinical/commercial DP formulation and filling manufacturing operations. Finally, responses should consider potential regulatory challenges based on proposed formulation and/or process changes. Note that it is possible that a vendor may not have expertise in all areas of this RFI, however vendors should provide information in the areas that can be supported. Information gathered at this time will help guide DVC in structuring the future potential Request For Proposal (RFP). This RFI announcement is for information purposes only; it is not to be construed as an obligation on the part of DVC. In order to proactively plan for future requirements, DVC is conducting market research to locate qualified, experienced, and interested large and small businesses to assess qualified, and experienced interested sources. No contract will be awarded from this announcement. No reimbursement will be made for any cost associated with providing information in response to this announcement. Please provide your capabilities statement for the following Task Areas, noting that any or all of the work scope may ultimately move forward. Responses shall include past performance for same or similar work performed. Background: The vaccine in the current DP formulation has been tested in nonclinical safety and efficacy studies. Phase 1 and Phase 2 clinical trials have been completed. Instructions Vendors should respond to one or more of the Task Areas for which they have applicable expertise. For each Task Area to which a vendor responds, please include the following information along with specific responses to the task area questions: - Provide a description of your facility and manufacturing capabilities. - Describe physiochemical analytical capabilities for characterization of an aluminum adjuvanted recombinant vaccine (i.e. purity, protein concentration, particulate identification, aluminum content, etc.) or comparable liquid suspension product. - Provide the qualifications of technical staff with demonstrated experience. - Describe relevant capabilities in Quality Systems, Regulatory Affairs and Support. Task Area A - Formulation Evaluation and Optimization 1. What scientific approaches would the offeror recommend to evaluate the optimal formulation of an aluminum adjuvanted recombinant vaccine DP formulation? 2. Describe current and previous experience with formulation development of aluminum adjuvanted vaccines or comparable liquid suspension products. Experience with specific adjuvants and vaccines should be detailed. 3. Describe current and previous experience with compounding and aseptic filling of clinical/commercial liquid suspension product into vials. 4. Describe physiochemical analytical capabilities for characterization of an aluminum adjuvanted recombinant vaccine (i.e. purity, protein concentration, particulates, aluminum content, etc.). Task Area B - Process Development 1. What technical approaches and methods would be used to ultimately develop a commercial process that could be used to manufacture an aluminum adjuvanted recombinant vaccine DP according to cGMP requirements? 2. Describe current and previous experience with manufacturing process development. 3. Describe experience with development of clinical manufacturing processes that were successfully transitioned to commercial manufacturing. 4. Provide a description of analytical capabilities available for DP Critical Quality Attribute (CQA) analysis (i.e. strength, purity, identity, etc.). Task Area C - Clinical/Commercial DP Manufacturing 1. Provide a description of the cGMP manufacturing capabilities of your facility, including number of clinical and commercial products being manufactured, and a description of quality systems. 2. Describe current and previous experience with manufacturing of aluminum adjuvanted and/or liquid suspension products. 3. Provide cGMP manufacturing experience including experience with transitioning products from clinical to commercial stage. 4. Describe production design in regards to flexibility and operating capacity targeting 30,000 to 100,000 unit lot size. 5. Describe how your facility addresses trends and challenges within industry, particularly as related to visual inspection of parenteral products (i.e. elimination of subjectivity in the visual inspection process, addition/changes to the USP guidance on visual inspection, etc.) 6. Provide a description of analytical capabilities available for DP CQA analysis (i.e. strength, purity, identity, etc.). Additional Required Information The following information shall be provided: 1. DUNS and CAGE Code Number 2. Tax ID Number 3. Company name and address 4. Principal Point of Contact, phone number and email (both technical and administrative/business) 5. NAICS codes associated with this capability 6. Company size (i.e. small business, 8(a), veteran owned, etc) Contact Information: All responses to this RFI shall be submitted no later than Wednesday, 9 May 2018 4:00 PM, Eastern Standard Time (EST) via email to Alesha.Subasic@CSRA.com. Disclaimer: This notice does not obligate DVC to award a contract or otherwise pay for the information provided in response. Note that DVC will not entertain questions regarding this Market Research; however, general questions can be presented in your response. Confidentiality: No proprietary, classified, confidential or sensitive information should be included in your response.

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