SOURCES SOUGHT
A -- Translational Research Chemistry, Manufacturing, and Control Program
- Notice Date
- 9/17/2015
- Notice Type
- Sources Sought
- NAICS
- 325411
— Medicinal and Botanical Manufacturing
- Contracting Office
- Department of Health and Human Services, National Institutes of Health, National Institute on Drug Abuse, 6001 Executive Boulevard, Room 4211 - MSC 9559, Bethesda, Maryland, 20892, United States
- ZIP Code
- 20892
- Solicitation Number
- HHS-NIH-NCATS-SBSS-16-001
- Archive Date
- 10/9/2015
- Point of Contact
- Jeffrey Schmidt, Phone: (301) 443-6677, Kirkland L. Davis, Phone: (301) 496-1813
- E-Mail Address
-
schmidtjr@mail.nih.gov, kd17c@nih.gov
(schmidtjr@mail.nih.gov, kd17c@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 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. Please note that to qualify as an eligible small business for purposes of a small business set-aside, at least 50% of the cost of contract performance incurred for personnel must be expended for employees of the small business awardee (see FAR 52.219-14 Limitations on Subcontracting). Background Researchers nationwide and across the globe face common barriers in translational research that can delay the development of new interventions for patients in need. The National Center for Advancing Translational Sciences (NCATS) at the National Institutes of Health (NIH) studies translation on a system-wide level as a scientific and operational problem to accelerate the development of treatments and preventive strategies for a wide range of diseases. Within NCATS, the Division of Pre-Clinical Innovation (DPI) plans, conducts and uses both internal and contract resources to advance collaborative research projects across the pre-clinical phases of the translational science spectrum. Contract research organizations (CROs) provide manufacturing, pharmacology, toxicology, regulatory, and clinical operations services to DPI to assist with probe and assay development, lead selection and optimization, and Investigational New Drug (IND)-directed studies. Purpose and Objectives The objective of the Translational Research Chemistry, Manufacturing, and Control (TRCMC) Program is to ensure the delivery of active pharmaceutical ingredients (API) and formulated drug product (DP) of identity, strength, and quality suitable for testing in preclinical and clinical studies (note: no human subject testing is to be performed under this contract). Project Requirements Written capability statements should demonstrate your organization's ability and related experience in one or more of the following separate Task Areas: (1) Small Molecules; (2) Synthetic Peptides and Oligonucleotides; and (3) Biopharmaceuticals (Biologics). If your organization has capabilities in more than one of the listed Task Areas, your response must separately describe the organization's ability and related experience for each separate Task Area. (1)Small Molecules Written capability statements should demonstrate your organization's ability and related experience in the following areas (Note: this Task Area does not include formulation development or manufacture of formulated drug product): Synthesis: -Process research and development to identify reliable, scalable and commercially viable processes -Process demonstration -Control of impurity profile and solid state form -Cost analysis -Manufacture of non-GMP Active Pharmaceutical ingredients (API) of sufficient quality and in quantities necessary to meet the needs of preclinical studies, typically 0.5 to 20 kg -Manufacture of API under current Good Manufacturing Practices (cGMP), of sufficient quality and in quantities to support IND-enabling and clinical studies, typically 0.5 to 20 kg; delivery of batch records, analytical methods, specifications and procedures -Synthesis and characterization of Reference Standard material -Characterization of solid state properties of API -Polymorph screening and selection of appropriate solid state form -Salt screening and selection of appropriate salt form Analytical: -Development and validation of analytical methods -Development and validation of stability-indicating methods -Identification, isolation, and characterization of impurities and degradation products -Development of specifications for API -Release testing of non-GMP and GMP API, delivery of COA -Evaluation of API stability per ICH guidelines Other: -Delivery of study reports, including CMC report in CTD format -Technology transfer when required -Storage of non-GMP and GMP lots of API -Compliance with cGMP -Maintain Quality systems to support cGMP activities (2)Synthetic Peptides and Oligonucleotides Written capability statements should demonstrate your organization's ability and related experience in the following areas (Note: this Task Area does not include formulation development or manufacture of formulated drug product): Synthesis: -Process research and development to identify reproducible synthesis and purification processes -Process demonstration -Control of impurity profile -Cost analysis -Manufacture of non-GMP Active Pharmaceutical ingredients (API) of sufficient quality and in quantities necessary to meet the needs of preclinical studies, typically 10 g to 1 kg -Manufacture of API under current Good Manufacturing Practices (cGMP), of sufficient quality and in quantities to support IND-enabling and clinical studies, typically 10 g to 1 kg; delivery of batch records, analytical methods, specifications and procedures -Synthesis and characterization of Reference Standard material Analytical: -Development and validation of analytical methods -Development and validation of stability-indicating methods -Identification, isolation, and characterization of impurities and degradation products -Development of specifications for API -Release testing of non-GMP and GMP API, delivery of COA -Evaluation of API stability per ICH guidelines Other: -Delivery of study reports, including CMC report in CTD format -Technology transfer when required -Storage of non-GMP and GMP lots of API -Compliance with cGMP -Maintain Quality systems to support cGMP activities (3)Biopharmaceuticals Written capability statements should demonstrate your organization's ability and related experience in the areas listed below. If your organization does not have capabilities in all areas listed below, you are still encouraged to respond and specify available areas of the organization's ability and related experience. Note: this Task Area does include formulation development and manufacture of formulated drug product. Scope of technical services for this Task Area includes development and manufacture of the following product types: recombinant proteins (bacterial or mammalian host), monoclonal antibodies, gene therapy or vaccine viruses, plasmids, cellular therapeutics. Desired capabilities include both manufacture of drug substance and aseptic fill finish of drug product. Required capabilities include items such as: -Construction of expression vectors (mammalian or microbial; specify capabilities) -Development of high-performance cell lines -Development of microbial strains -Production of Development Cell Bank (RCB) -Production of cGMP Master Cell Bank (MCB) -Production of Working Cell Bank (WCB) -Characterization of cell banks per ICH guidelines and other applicable regulatory guidelines (the offeror must provide examples of typical MCB characterization plans) -Cell culture media and feed optimization -Development of robust upstream processes -Development of scalable downstream purification processes -Determination of critical process parameters -Determination of stability of intermediates -Process optimization using DoE -Development of analytical methods, including stability-indicating methods, for In-Process Control (IPC), Bulk Drug Substance (BDS) release, Drug Product (DP) release and stability evaluation (provide a list of analytical methods typically developed at your organization's facility for each of the activities above, and list of methods typically used by the your organization but developed and executed at outsourced subcontractor facilities) -Qualification or validation of analytical methods, per ICH guidelines -Identification, isolation, and characterization of impurities and degradation products -Development of Specifications -Production of non-GMP lots of BDS (expected 10 g to 200 g) -Viral clearance validation -Manufacture of GMP lots of BDS (expected 10 g to 200 g) to support IND-enabling and clinical studies; delivery of batch records, analytical methods, specifications and procedures -Generation and characterization of Reference Standard (RS) material -Development of DP formulation for injectable products -Manufacture of cGMP DP (fill finish) of sufficient quality and in quantities to support IND-enabling and clinical studies; delivery of batch records, analytical methods, specifications and procedures -Manufacture and release of cGMP viral vectors / vaccines -Stability evaluation of RS, BDS and DP, per ICH guidelines -Tech transfer to a third party facility if necessary Other: -Delivery of study reports, including in CTD format -Technology transfer when required -Storage of non-GMP and GMP lots of BDS and DP -Compliance with cGMP -Maintain Quality systems to support cGMP activities Specify whether your organization uses any proprietary technology for any of the activities described for Task Areas I, II and III. If so, clarify whether NCATS and NCATS collaborators will have freedom to use the technology at a third party facility in case the project is later transferred to a third party. In addition, your organization's capability statement should: (1)Indicate how many staff members the small business would be able to dedicate to the program, and which of those would be available in-house; (2)Identify which requirements would be performed in-house versus those that would be performed outside your organization; and (3)Describe your organization's ability to rapidly scale staff capacity up or down to support the anticipated workload. Anticipated Period of Performance The Government anticipates making multiple Indefinite Delivery/Indefinite Quantity (ID/IQ) type contract awards under the future solicitation-each with a five year ordering period. The Government anticipates awards will be made in the fourth quarter of FY2016. Other Important Considerations Work performed under this program must be conducted in accordance with Current Good Manufacturing Practices regulations (cGMPs) and, as appropriate, Good Laboratory Practice regulations. In addition, data and documentation generated under this program must be prepared in a form acceptable to the FDA for inclusion in a Drug Master File (DMF), IND application, or New Drug Application (NDA). To enable Contributors to retain control of the intellectual property for compounds created through the TRCMC program, the Government has sought a Declaration of Exceptional Circumstances (DEC) to the Federal Acquisition Regulations (FAR) for this program. Required Information All capability statements must provide the following: (1) DUNS number; (2) organization name; (3) organization address; (4) point of contact; (5) point of contact title, address, telephone, and email address; and (6) size and type of business (e.g., 8(a), HUBZone, etc.) pursuant the applicable NAICS code. Submission Instructions and Due Date Written capability statements must be SUBMITTED NO LATER THAN OCTOBER 8, 2015 to the below Contracting Office Address, Attn: Jeffrey Schmidt. Electronic capability statements will be accepted by the primary point of contact. 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 pre-solicitation 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). Contracting Office Address NINDS R&D Contracts Management Branch NCATS Section 6001 Executive Boulevard Suite 3287, MSC 9531 Bethesda, Maryland 20892-9531* *Use Rockville, MD 20852 for Fed-Ex/USPS/Courier/Hand-Delivery
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/NIH/NIDA-01/HHS-NIH-NCATS-SBSS-16-001/listing.html)
- Record
- SN03892251-W 20150919/150918000726-517e0be18a5f24f20951d94eaf846d12 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
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