Inactive Total Small Business Set-Aside (FAR 19.5)

Chemistry, Manufacturing and Controls and Related Services for Development of Drug Substances Classification Code/Title: AN12 - Health R&D Services; Health care services; Applied Research NAICS Code/T... Chemistry, Manufacturing and Controls and Related Services for Development of Drug Substances Classification Code/Title: AN12 - Health R&D Services; Health care services; Applied Research NAICS Code/Title: 325411 - Medicinal and Botanical Manufacturing Related Notice: Presolicitation Notice ID PS75N95024R00094, Chemistry Manufacturing and Controls for Drug Development Programs, published June 21, 2024. Purpose of Notice: This is a Research and Development (R&D) 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 the availability and capability of Small Business sources to perform a potential R & D requirement. 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. 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. The Government will not entertain questions regarding the results of this market research. Background: The Division of Preclinical Innovation (DPI) at the National Center for Advancing Translational Sciences (NCATS) conducts translational research on human therapeutics development by moving small molecule and biologic drug candidates forward in the drug development pipeline. Upon reaching predetermined milestones, DPI hands off clinical candidates to external partners to bring these novel therapies to patients. In addition to developing new candidate drugs, DPI seeks to advance the entire field of drug discovery and development by encouraging scientific and technological innovations aimed at improving success rates in the crucial preclinical stage of drug development. DPI’s model is to operate as a comprehensive small molecule and biologics drug development organization, moving therapeutic candidates through each phase of the preclinical development process until an Investigational New Drug (IND) application is filed with the US Food and Drug Administration (FDA). For certain drug development campaigns, DPI will support studies up to human Phase IIb. DPI conducts drug development through collaborations, with therapeutic candidates originating from academia, industry, non-profit foundations, or internally from NCATS and other NIH institutes. DPI’s operational strategy is to combine the capabilities of in-house staff and collaborative partners, who may be the drug originators, with complementary support from contract research organizations (CROs). Each development program operates in a multi-disciplinary matrix team environment, with a DPI project officer (PO) responsible for overall planning, execution, and reporting. The NCATS has an existing multiple-award IDIQ contract for Drug Substance Development and Manufacture. This potential procurement would be a re-competition of this existing contract. Purpose and Objectives: The purpose of this Small Business Sources Sought is to obtain information about Small Business capabilities to support the DPI drug development programs by providing Chemistry, Manufacturing, and Control (CMC) services; specifically, the scale-up production of active pharmaceutical ingredients / drug substances. The goal of these support services is to ensure DPI receives Drug Substance (DS) of sufficient quality and quantity to support preclinical and IND-enabling studies. Product formats may include small molecules, short oligomeric compounds, biological (large) molecules, quaternary molecular assemblies (homogenous or heterogenous), and any of the above modified genetically, biologically, or chemically. Novel formats identified after this draft might also be needed. Formats could also include Devices or Combination Products. Project Requirements: The potential acquisition is anticipated to be a multiple-award Indefinite Delivery / Indefinite Quantity (IDIQ) contract for Chemistry Manufacturing and Controls for Drug Substances. The anticipated IDIQ contract(s) would have three separate technical areas: Process Development Manufacture and Analysis of Small Molecule Drug Substances; Process Development, Manufacture and Analysis of Synthetic Peptides, Oligonucleotides, and Related Drug Substances; and Process Development, Manufacture and Analysis of Biopharmaceutical Drug Substances. The anticipated IDIQ contract(s) may be awarded under one or more technical areas. The contractor shall be compliant with applicable domestic or international regulations. These may include, but are not limited to one or more of the following: US FDA current Good Manufacturing Practice (cGMP), Good Laboratory Practice (GLP) and Good Clinical Practice (GCP) regulations, and/or International Council for Harmonisation (ICH) and International Organization for Standardization (ISO) regulations. The contractor shall provide biohazard, environmental and occupational health safety, emergency management/preparedness, security, transportation and logistics services. All work with hazardous biological materials shall comply with all applicable regulations. Anticipated period of performance: The potential IDIQ contract(s) are expected to have a five-year ordering period. Task orders issued under the IDIQ contract(s) will have their own periods of performance that are based on the specific requirement. Information Requested: Vendors should provide a capability statement that addresses their capability and experience in one or more of the below technical areas AND the overall technical requirements. Vendors may provide a capability statement in one area, two areas, or all three areas. Capability statements should address the overall technical requirements as applied to each technical area in the capability statement. Vendors with prior, similar experience should clearly demonstrate that experience and include information on the size and scope of that experience. If prior experience was gained with the Government as a prime or subcontractor, describe the size and scope of the work and provide the contract number. Capability statements should address each point listed under the applicable technical area(s). Capability statements must address the specific technical area(s) and points in this Notice; general capability statements will not be reviewed. Vendors seeking to respond to this Notice as part of a teaming arrangement should include the requested information from each vendor in the proposed team. OVERALL TECHNICAL REQUIREMENTS Vendors must have the capability to perform the below activities for any and all of the technical areas in their capability statement. The below activities may be required under each technical area. Vendors should address their capability and experience with the following activities related to each technical area addressed in the capability statement. a. Performing technology transfer to / from the Government or a third party. b. Determining critical/key process parameters and optimize processes using Design of Experiments (DoE). c. Performing process demonstration runs. d. Synthesizing and characterizing Reference Standard material for Drug Substances under cGMP, of sufficient quality and in quantities to support IND-enabling and clinical studies (typically 0.5 to 20 kg). e. Developing, validating, and qualifying analytical methods. f. Developing and validating stability-indicating methods. g. Developing release specifications. h. Performing release testing of Drug Substance including a certificate of analysis (COA). i. Establishing stability protocols with proper specifications for Reference Standards and Drug Substances, and performing stability studies per guidelines published by the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). j. Storing non-GMP and GMP lots of Drug Substances. k. Ensuring compliance with Good Manufacturing Practices (GMP). TECHNICAL AREA 1: PROCESS DEVELOPMENT, MANUFACTURE AND ANALYSIS OF SMALL MOLECULES Vendors should address their capability and experience with the following activities related to the process development, manufacture, and analysis of small molecules: a. Conducting process research and development to identify reliable, scalable, and commercially viable processes. b. Performing route scouting. c. Optimizing synthetic steps. d. Conducting polymorph screening, selecting appropriate solid-state forms, and characterizing solid-state properties. e. Conducting salt screening and selecting appropriate salt forms. f. Synthesizing intermediate compounds. g. Characterizing, isolating, and synthesizing reference samples of process impurities. h. Conducting solvent screening for the selected solid-state. i. Ensuring control of impurity profile and solid-state form. j. Manufacturing non-GMP Drug Substances of sufficient quality and in quantities necessary to meet the needs of preclinical studies (typically 0.5 to 20 kg). k. Identifying, isolating, and characterizing impurities and degradation products. l. Developing necessary in process control (IPC) methods for Drug Substance manufacturing. TECHNICAL AREA 2: PROCESS DEVELOPMENT, MANUFACTURE AND ANALYSIS OF SYNTHETIC PEPTIDES, OLIGONUCLEOTIDES, AND RELATED SUBSTANCES Vendors should address their capability and experience with the following activities related to the manufacture and analysis of synthetic peptides, oligonucleotides, and related substances: a. Conducting process research and development to identify reproducible synthesis and purification processes. b. Ensuring control of impurity profile. c. Identifying, isolating, and characterizing impurities and degradation products. d. Manufacturing non-GMP Drug Substances of sufficient quality and in quantities necessary to meet the needs of preclinical studies (typically 10 g to 1 kg). e. Manufacturing cGMP Drug Substances of sufficient quality and in quantities to support IND-enabling and clinical studies (typically 0.5 kg to 20 kg). TECHNICAL AREA 3: PROCESS DEVELOPMENT, MANUFACTURE AND ANALYSIS OF BIOPHARMACEUTICAL DRUG SUBSTANCES Vendors should address their capability and experience with the following activities related to the manufacture and analysis of biopharmaceuticals: a. Developing Mammalian stable cell lines. b. Developing microbial strains. c. Performing lab scale process development using controlled bioreactors and purification skids to define clinical manufacturing process. d. Performing excipient screening, optimizing, and developing final formulation buffer. e. Performing characterization of Drug Substance for identity, content, purity and potency. f. Manufacturing non-GMP Drug Substances of sufficient quality and in quantities to support IND-enabling and clinical studies (typically 10 g to 300 g). g. Manufacturing cGMP Drug Substances of sufficient quality and in quantities to support IND-enabling and clinical studies (typically 0.5k g to 20 kg). Response Instructions: Responses are required no later than 10:00am Eastern Time on July 21, 2024. Responses must be submitted via email to samson.shifaraw@nih.gov and should include the following: a. Capability statement that addresses one or more technical areas AND the overall technical requirements as applied to each technical area in the capability statement. b. Cover Page that includes the following: • DUNS • Company Name • Company Address • Company Point of Contact, Phone, and Email address • NAICS code under which the company conducts business as a small business • Company Size / Socio Economic status (e.g., small business, 8(a), woman owned, veteran, etc.) - validated via SAM State whether your organization uses any proprietary technology for any of the activities described for Technical Areas 1, 2, or 3. If so, clarify whether NCATS and NCATS’ collaborators will have freedom to use the technology at a third-party facility in the event the project is later transferred to a third party. State whether there are any classes of scheduled compounds or hazardous reagents / reactions your organization is unable to handle due to regulation or safety limitations. Acknowledgment of compliance with FAR Clause 52.219-14. As noted below, FAR Clause 52.219-14 will apply to any portion of the acquisition that is set aside for Small Business. Respondents must acknowledge they will comply with this clause if they are awarded an IDIQ contract under a set-aside. Respondents who fail to acknowledge this will be deemed not capable for the purposes of this Small Business Sources Sought. 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 SAM. However, responses to this notice will not be considered adequate responses to a solicitation. If any portion of the potential acquisition is set aside for Small Business, FAR Clause 52.219-14, Limitations on Subcontracting, will apply to the portion that is set aside. This clause states the prime Small Business contractor cannot subcontract more than 50% of the work to a non-similarly situated entity. The full text of the clause is available at https://www.acquisition.gov/far/part-52#FAR_52_219_14. To enable Contributors to retain control of the intellectual property for compounds created under the anticipated IDIQ contracts, the Government is seeking a Declaration of Exceptional Circumstances (DEC) to the Federal Acquisition Regulations (FAR) for this program. 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).