SOURCES SOUGHT
68 -- Manufacture of an E-selectin Fragment using the BEVS Platform
- Notice Date
- 3/27/2014
- Notice Type
- Sources Sought
- NAICS
- 325412
— Pharmaceutical Preparation Manufacturing
- Contracting Office
- Department of Health and Human Services, National Institutes of Health, National Institute on Drug Abuse, Station Support/Simplified Acquisitions, 31 Center Drive, Room 1B59, Bethesda, Maryland, 20892
- ZIP Code
- 20892
- Solicitation Number
- HHS-NIH-NIDA-SSSA-SBSS-14-139
- Archive Date
- 9/30/2014
- Point of Contact
- Debra C. Hawkins, Phone: (301) 594-2178
- E-Mail Address
-
Debra.Hawkins@nih.gov
(Debra.Hawkins@nih.gov)
- Small Business Set-Aside
- N/A
- Description
- 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 they are small businesses; HUBZone small businesses; service-disabled, veteran-owned small businesses; 8(a) small businesses; veteran-owned small businesses; woman-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 small business social-economic set-aside, competitive or non-competitive method is possible, and to determine the availability of qualified companies technically capable of meeting the Government's requirement. An organization that is not considered a small business under the applicable NAICS code should not submit a response to this notice." 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. Background: The mission of National Institute of Neurological Disorders and Strokes (NINDS) is to seek fundamental knowledge about the brain and nervous system and to use that knowledge to reduce the burden of neurological disease. This entails bringing novel therapeutics, diagnostics, and other technologies to patients who need them. Despite the use of antithrombotic drugs for the prevention of recurrent strokes, 10% of patients who experience a cerebral ischemic event will go on to have a stroke within 90 days. The development of new treatment strategies for prevention of the various forms of recurrent stroke is an important issue for modern medicine. The principle for the use of E-selectin is the increasing evidence that a state of chronic, subtle immune dysregulation that leads to inflammation at the sites of endothelial activation plays an important role in the pathogenesis of strokes. Control of such molecular inflammation at the sites of endothelial activation can be achieved by induction of mucosal tolerance. This approach to stroke prevention differs from conventional measures. It will very likely synergize with existing clinical regimens for prevention of stroke and will stimulate a great deal of research in this under-explored area. Purpose and Objectives: This requirement is for the purchase of service for the creation and production of current Good Manufacturing Practice (cGMP) grade recombinant human E-selectin (rhE-selectin) drug substance using a Baculovirus Expression Vector System (BEVS) in an insect cell platform. Services include the creation, production and maintenance of a cGMP Master Virus Seed Bank, Master Cell Bank and optional Working Cell and Virus Seed Banks. Volume of final product will be enough to support toxicology and two clinical trials Project requirements: This requirement includes: a) Creation and maintenance of a cGMP Master Virus Seed Bank and possibly an optional Working Virus Seed; b) Creation and maintenance of a Master Cell Bank and optional Working Cell Bank; c) Creation and testing of End of Production Cell Bank d) Creation and maintenance of Reference Standard; e) Manufacturing scale up using proposed or newly optimized manufacturing plan; f) Procurement and receipt all necessary raw materials; maintenance of appropriate inventory control g) Qualification of all critical raw material vendors and any testing sub-contractors h) Production of cGMP grade recombinant E-selectin drug substance using a Baculovirus Expression Vector System (BEVS) in an insect cell platform in amounts to be specified; • The amount of rhE-selectin required will be presented in the final contract. The working estimates are that approximately 100 mg will be required from early batch for rodent model studies, approximately 2,000 mg for toxicology and additional research studies, and approximately 1,000 mg for clinical studies, • Specifically, the 282aa recombinant human E-selectin that (i) contains a secretory signal peptide, which is removed during secretion, (ii) has complete homology to the human E-Selectin sequence except for a signal peptide and the two amino acid residues (Arg-Ser) at the carboxy terminus, which are derived from the translation of linker sequence in the baculovirus expression vector and (iii) any c-myc, histidine or other tag sequences are eliminated. There are significant advantages in recombinant protein quality, productivity, post-translational processing and biological activity, and therefore we expressly require, that the expression be done in insect cells. Molecular mass specifications are the 282 amino acid sequence of the amino terminal of the extra membranous domain of human E-selectin comprised of lectin, epidermal growth factor, and complement regulatory factor repeats beginning with ‘WSYNT...' and ending with ‘....CKAVT'. i) Performance of fill and finish for vialed sterile drug product for use in clinical trials j) Development and qualification of analytical assays to support in process testing, release testing for drug substance, release testing for drug product, stability testing for drug substance and stability testing for drug product; k) Performance of product release and provision of Certificate of Analysis for rhE-selectin DS and DP, using tests and preliminary acceptance criteria specified Table 3 and Table 5; l) Performance of stability testing of drug substance and drug product with assays specified in Table 6; m) Provision of radiolabelled E-selectin, approximately 60-70 mg. n) Provision of experienced staff with to write CMC portions of IND and participate in any required written or verbal interaction with FDA. o) Provide deliverables that include human E-selectin product in a time frame allowing for production and the start of Good Laboratory Practice (GLP) toxicology and immunotoxicology testing in twelve to fifteen months from time of contract release; p) Capability to develop formulations of recombinant proteins for long-term stability and can perform accelerated and long term stability testing using appropriate assay testing; q) Assure the recombinant E-selectin shall be purified and tested for stability, sterility, purity, identity, strength and potency, and dose concentrations; r) Provide placebo, consisting of formulation without protein; s) Prepare and approve all necessary GMP documentation and maintain a Quality System necessary to support GMP manufacturing. Anticipated period of performance: The anticipated period of performance 24 months from the date of contract award. Capability statement /information sought. Interested parties are expected to review this notice to familiarize itself with the requirements of this project. Failure to do so will be at your firm's own risk. 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. Respondents must provide a general overview of the respondent's opinions about the difficulty and/or feasibility of the potential requirement, and any information regarding innovative ideas or concepts. In addition, the capability statement shall include: (1) the respondents' opinions about the difficulty and/or feasibility of the potential requirement or proposed acquisition, possible solutions and approaches that may currently exist in the marketplace, and information regarding innovative ideas or concepts; (2) information regarding respondent's prior experience and past performance on experience providing similar requirements. Response must include specific examples of prior completed Government contracts, references, and other related information. Response must include demonstrated expertise and experience in drug manufacturer. Specific examples of drug manufacturing must be provided; (3) information on the proposed key personnel combination of advanced education, board certifications, staff expertise, including their availability, experience, and formal and other training; and any other advanced expertise explicitly applicable to the requirement; (4) information on corporate experience and management capability of the respondent ability to manage the requirement of this type and magnitude; (5) information on respondents relationship with the United States Food and Drug Administration; and (6) any other information that may be helpful in determining the respondents capability and or developing or finalizing the acquisition requirements. The respondent must also provide their DUNS number, organization name, address, point of contact, and size and type of business (e.g., 8(a), HubZone, etc.) pursuant to the applicable NAICS code and any other information that may be helpful in developing or finalizing the acquisition requirements. One (1) copy of the response is required and must be in Microsoft Word or Adobe PDF format using 11-point or 12-point font, 8-1/2" x 11" paper size, with 1" top, bottom, left and right margins, and with single or double spacing. The information submitted must be must be in and outline format that addresses each of the elements of the project requirement and in the capability statement /information sought paragraphs stated herein. A cover page and an executive summary may be included but is not required. The response is limited to ten (10) page limit. The 10-page limit does not include the cover page, executive summary, or references, if requested. The response must include the respondents' technical and administrative points of contact, including names, titles, addresses, telephone and fax numbers, and e-mail addresses. All responses to this notice must be submitted electronically to the Contract Specialist and Contracting Officer. Facsimile responses are NOT accepted. The response must be submitted to Debra C. Hawkins, Contracting Officer, at e-mail address debra.hawkins@nih.gov. The response must be received on or before April 18, 2014, 12:00 noon, Eastern Time. "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 Federal Business Opportunities. However, responses to this notice will not be considered adequate responses to a solicitation. 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(s).
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- SN03322429-W 20140329/140327235005-861410b7d332f5af4058f8a828a2635e (fbodaily.com)
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