SOURCES SOUGHT
A -- NIAID Process Development of Proteins for HIV Vaccines
- Notice Date
- 3/4/2015
- Notice Type
- Sources Sought
- NAICS
- 541712
— Research and Development in the Physical, Engineering, and Life Sciences (except Biotechnology)
- Contracting Office
- Department of Health and Human Services, National Institutes of Health, National Institute of Allergy and Infectious Diseases, Office of Acquisitions, 5601 Fishers Lane, 3rd Floor, MSC 9821, Bethesda, Maryland, 20892, United States
- ZIP Code
- 20892
- Solicitation Number
- HHS-NIH-NIAIDAI-SBSS-14013
- Archive Date
- 4/2/2015
- Point of Contact
- Craig D. Heggestad, Phone: 240-669-5158, Michelle L Scala, Phone: 240-669-5156
- E-Mail Address
-
heggestadcd@niaid.nih.gov, mscala@niaid.nih.gov
(heggestadcd@niaid.nih.gov, mscala@niaid.nih.gov)
- Small Business Set-Aside
- N/A
- Description
- Introduction This is a Small Business Sources Sought notice. This is NOT a solicitation for proposals, proposal abstracts, or quotations. The purpose of this notice is to obtain information regarding: (1) the availability and capability of qualified small business sources; (2) whether there are small businesses; HUBZone small businesses; service disabled, veteran-owned small businesses; 8(a) small businesses; veteran-owned small businesses; women-owned small businesses; or small disadvantaged businesses; and (3) their size classification relative to the North American Industry Classification System (NAICS) code for the proposed acquisition. Your responses to the information requested will assist the Government in determining the appropriate acquisition method, including whether a set-aside is possible. An organization that is not considered a small business under the applicable NAICS code should not submit a response to this notice. Background The development of vaccines to prevent the spread of HIV infection is among the National Institute of Allergy and Infectious Diseases (NIAID) highest priorities. In addition, vaccines administered to infected individuals have potential for inducing immune control of the infectious agent. While advances in immunology and molecular biology continue to offer an expanding array of approaches for the development of new vaccines/products, there is limited capacity and expertise to move promising concepts through the development process. Translational development activities, which are needed to bridge this gap, appear to be especially limited and thus have influenced the pace at which basic research findings can be evaluated in the clinic. To bridge the gap in translational development, NIAID specifically proposes to support two key critical components: process development and analytical characterization activities. This contract will provide targeted specialized expertise and facilities for process development or analytic characterization. We anticipate awarding an Indefinite Delivery Indefinite Quantity (IDIQ) contract to one organization that meets the overall qualifications needed to fulfill the technical requirements. The Contractor shall carry out, either directly or through subcontractors and/or consultants, tasks in the following areas: •Coordination and Technical Support (Central Functions) •Process Development •Analytical Characterization and Method Development Purpose and Objectives The purpose of the proposed contract is to provide NIAID with a wide range of capabilities that are required for the product development of proteins for evaluation in clinical trials as vaccines. These activities are initiated prior to filing an Investigational New Drug (IND) application and continue as part of product development during ongoing clinical trials (Phase 2 and 3 chemistry, manufacturing, and control (CMC) activities). Access to product development activities (manufacturing process development and optimization, analytical characterization and assay development) is intended to facilitate the advance of potential HIV protein vaccines in Phase 1, 2, and 3 clinical trials. The majority of the work performed under this contract will focus on HIV proteins as vaccine components. NIAID may issue task orders to support work of other vaccine components. Project Requirements Offerors should have the qualifications, experience and capability to perform this requirement. The Contractor will carry out tasks in the following three areas: A.Task Area 1: COORDINATION AND TECHNICAL SUPPORT (CENTRAL FUNCTIONS) 1.Scope of Task Area 1: Plan, initiate, implement, manage, and coordinate the activities of all Task Orders. Coordinate the management of all awarded Task Orders and monitor overall progress within each Task Order. Task Order-specific project management activities will be incorporated into the Statements of Work for each individual Task Order. 2.Requirements for Task Area 1: a.Provide general administration, project management, and coordination of all contract activities. Task Order-specific project management activities for other Task Orders are to be included under each individual Task Order, and not within Task Area 1; b.Provide quality assurance/quality control (QA/QC) oversight of all Task Order activities; c.Coordinate, organize and participate in Site Visits, ad hoc meetings and teleconferences; d.Prepare and submit reports and respond to requests for information; e.Conduct transition activities f.Coordinate and manage the receipt, storage, and shipping of compounds and reagents as needed. B. Task Area 2: ANALYTICAL CHARACTERIZATION AND METHOD DEVELOPMENT 1.Scope of Task Area 2: This Task Area will support activities required for development of analytical methods to be used for characterization, quality control and product release and stability through final formulation in combination with adjuvants. This task area includes performance of assays needed for product characterization. 2.Requirements for Task Area 2: a.Manage, develop and conduct analytical characterization methods to assess the physico-chemical structure and biological activity of HIV protein or other vaccine candidates. Methods may include but are not limited to cryo-electron microscopy, surface plasmon resonance (SPR) to measure affinity of protein antigens to monoclonal antibodies and/or CD4, analysis of glycosylation patterns, analysis of higher order structures by size-exclusion chromatography + multi angle light scattering (SEC-MALS), and mass spectrometry; b.Include methods that evaluate both the structure and function of the molecule, and assure that the HIV proteins or other products maintain the key product attributes through all stages of production (upstream and downstream) and through final formulation with an adjuvant; c.Develop and evaluate novel methods for suitability as characterization or quality control (QC) assays; d.Ensure methods developed for QC purposes have the required level of qualification/validation for the intended phase of development (see ICH Q6B ICH Harmonized Tripartite Guideline "Specifications: Test Procedure and Acceptance Criteria for Biotechnological/Biological Products" for guidance on developing and applying analytical methods for biological products); and e.Ensure assays are scientifically sound and appropriately documented. f.Arrange for receipt, storage, inventory, retrieval and shipping of compounds, reagents, specimens, and products in accordance with federal guidelines, as requested. C. Task Area 3: PROCESS DEVELOPMENT 1.Scope of Task Area 3: Provide overall oversight, management and conduct of process development activities that develop, evaluate, and establish manufacturing processes for HIV proteins that may be included in an HIV vaccine (e.g. Env proteins). The manufacturing process should be suitable for use in Phase 1/2 CGMP manufacturing with respect to efficiency and scalability and the materials and technologies employed. Examples of specific activities that may be requested under this task area include both upstream activities (cell line and clone development, optimization of cell growth and protein expression) and/or downstream activities (purification processes). Established and novel technologies shall be employed to improve product yields and purities. Parallel formulation activities shall be developed for adjuvant compatibility. As requested, arrange for receipt, storage, inventory, retrieval and shipping of compounds, reagents, specimens and products in accordance with federal guidelines. 2.Requirements for Task Area 3: a.Upstream Activities include but are not limited to Develop cell lines with high expression levels of Env protein, through use of current and novel technologies intended to improve recombinant protein production i.Prepare cell banks or appropriate research materials that can be used for subsequent GMP activities ii.Develop approaches for rapid screening and identification of mammalian cell lines expressing HIV Env protein iii.Develop alternative expression systems for high level expression of HIV Env protein candidates including the use of transient cell lines and cell-free protein production iv.Optimize bioreactor cultures to include improved yield and improved product stability b.Downstream Activities- include, but are not limited to i.Identify and optimize purification processes to achieve suitable purity, homogeneity, and yield of HIV Env proteins ii.Screen and select formulations suitable for use in clinical studies Performance Requirement and Anticipated Period of Performance The anticipated period of performance is for seven years beginning April 1, 2016 through March 31, 2023. Capability Statement/Information Sought Capability Statements should clearly convey information regarding the respondent's capabilities, including: (a) staff expertise, including their availability, experience, and formal and other training; (b) current in-house capability and capacity to perform the work; (c) prior completed projects of similar nature; (d) corporate experience and management capability; and (e) examples of prior completed Government contracts, references, and other related information. Interested contractors must submit a capability statement (ten page limitation, excluding resumes) describing their company's experience and ability to perform this effort that includes the following: (1) a summary list of similar work previously performed; (2) the professional qualifications and specific experience of staff who may be assigned to the requirement; (3) resumes for proposed key personnel, including the Principal Investigator, that reflect education, and previous work relevant to the proposed requirement; (4) a general description of the facilities and other resources needed to perform the work; and (5) demonstrated ability to carry out the work. Each response should include the following Business Information: a.DUNS number b.Company Name c.Company Address d.Company Points of Contact (both technical and administrative), including names, titles, addresses, telephone and fax numbers and Email addresses e.Current GSA Schedule appropriate to this Sources Sought f.Do you have a Government-approved accounting system? If so, please identify the agency that approved the system. g.Type of Company (i.e., small business, 8(a), woman owned, veteran owned, etc.) as validated via the System for Award Management (SAM). All offerors must be registered in the SAM, located at http://www.sam.gov/ Teaming Arrangements: All teaming arrangements should also include the above-cited information and certification for each entity on the proposed team. Teaming arrangements are encouraged. NIAID recognizes that no single organization or institution may have the expertise and facilities required to perform all of the tasks mentioned above. Therefore, the Contractor may need to utilize the expertise and resources of subcontractors and specialized consultants to provide the full spectrum of requested activities. The Contractor shall be responsible for ALL work performed under this contract including that performed by any subcontractors and consultants. The Contractor will ensure that any and all processes meet international, federal, local and state regulations to ensure the continuity and validity of the resulting product. Responses must be submitted no later than 4:00 PM, March 18, 2015 Capability statements will not be returned and will not be accepted after the due date. These statements must be submitted electronically by e-mail to Craig Heggestad, Contract Specialist, with a copy to Michelle Scala, Contracting Officer, at the email addresses indicated below.. Electronic submissions should be submitted in PDF format, however, Microsoft Word or Corel WordPerfect will be accepted. In the subject line, please reference: HHS-NIH-NIAID(AI)-SBSS-14013. Craig Heggestad Contract Specialist, Office of Acquisitions National Institute of Allergy and Infectious Diseases, NIH heggestadcd@niaid.nih.gov Michelle Scala Contracting Officer, Office of Acquisitions National Institute of Allergy and Infectious Diseases, NIH mscala@niaid.nih.gov Disclaimer and Important Notes This notice does not obligate the Government to award a contract or otherwise pay for the information provided in response. The Government reserves the right to use information provided by respondents for any purpose deemed necessary and legally appropriate. Any organization responding to this notice should ensure that its response is complete and sufficiently detailed to allow the Government to determine the organization's qualifications to perform the work. 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. After a review of the responses received, a Presolicitation synopsis and solicitation may be published in the Federal Business Opportunities. However, responses to this notice will not be considered adequate responses to a solicitation. The Government will not entertain questions regarding this Market Research; however, general questions may be emailed to the following addresses: Contract Specialist: Craig Heggestad Email Address: heggestadcd@niaid.nih.gov Contracting Officer: Michelle L. Scala Email Address: mscala@niaid.nih.gov Confidentiality No proprietary, classified, confidential, or sensitive information should be included in your response. The Government reserves the right to use any non-proprietary technical information in any resultant solicitation.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/NIH/NIAID/HHS-NIH-NIAIDAI-SBSS-14013/listing.html)
- Place of Performance
- Address: Place of performance is unknown at this time, United States
- Record
- SN03659176-W 20150306/150304235647-14379f82168de499d240edef9cce0cf5 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
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