The development of a safe and efficacious preventive HIV-1 vaccine is one of the highest priorities of the National Institute of Allergy and Infectious Diseases (NIAID). NIAID supports a portfolio of ... The development of a safe and efficacious preventive HIV-1 vaccine is one of the highest priorities of the National Institute of Allergy and Infectious Diseases (NIAID). NIAID supports a portfolio of preclinical, translational, and clinical research to advance HIV vaccine efforts. The Division of AIDS (DAIDS) supports research programs to discover novel vaccine strategies, assess correlates of immunogenicity and of protections elicited by experimental vaccines and provides an infrastructure for the manufacturing and testing of novel products. To achieve this goal, the Government anticipates awarding Indefinite Delivery/Indefinite Quantity (IDIQ) contracts to multiple Contractors that meet the overall qualifications for individual Task Areas. There are two current single-award IDIQ contracts that provide preclinical services for HIV Vaccine efforts ranging from initial product discovery through full current Good Manufacturing Practices (CGMP) manufacturing and readiness for clinical trials and/or product licensure. Contract No. HHSN272201700010I, with Advanced BioScience Laboratories, Inc. (ABL), entitled “NIAID Preclinical Development Support” was awarded in June 2017 as a single award IDIQ type contract for a period of seven years (6/10/2017 through 6/9/2024) and a maximum quantity of $318,500,000.00. Contract No. HHSN272201600011I, with the International AIDS Vaccine Initiative (IAVI), entitled “NIAID Process and Analytical Support for Development of HIV Vaccines” was awarded in July 2016 as a single-award IDIQ type contract for a period of seven years (7/15/2016 through 7/14/2023) and a maximum quantity of $98,587,183.00 The current Contractors have provided preclinical services including: manufacturing feasibility assessments, analytical characterization and method development, audits, regulatory documentation, process development and current Good Manufacturing Practices (CGMP) manufacturing, and safety and immunogenicity studies. Additional services have included project management, technical support, quality assurance, product shipping and storage, and document management. Changes to the contract requirements from previous IDIQ single-award competitions include use of the multiple award structure and incorporating activities currently found in the Essential Core Activities Task Area into each Task Order in the new awards. The purpose of this solicitation is to award multiple IDIQ contracts to support the full range of activities for preclinical and translational support services from initial product discovery through full (CGMP) manufacturing and readiness for clinical trials and/or product licensure. The contracts will support tasks in the following areas: • Research and Development Product Storage and Shipping (Task Area A) • Safety and Immunogenicity Studies (Task Area B) • Feasibility Studies and Early Manufacturability Assessments (Task Area C) • Analytical Characterization and Method Development (Task Area D) • Process Development, CGMP Manufacturing, and Stability (Task Area E) • Fill-Finish, Packaging, and Labeling (Task Area F) • Scientific, Quality, and Regulatory Support Services (Task Area G) NIAID anticipates Task Orders issued against the IDIQ contracts will be cost reimbursement and/or firm fixed price. While the Base IDIQ contracts will not have options, options may be included at the individual Task Order level. It is anticipated that NIAID will award Base contracts to one or multiple contractors for each of the Task Areas A, B, C, D, E, F, and G. Task Area G is set aside for small business concerns.
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PRECLINICAL AND TRANSLATIONAL VACCINE DEVELOPMENT FOR HIV AND OTHER CANDIDATE AGENTS Background The development of a safe and efficacious preventive HIV-1 vaccine is one of the highest priorities of t... PRECLINICAL AND TRANSLATIONAL VACCINE DEVELOPMENT FOR HIV AND OTHER CANDIDATE AGENTS Background The development of a safe and efficacious preventive HIV-1 vaccine is one of the highest priorities of the National Institute of Allergy and Infectious Diseases (NIAID). NIAID supports a portfolio of preclinical, translational, and clinical research to advance HIV vaccine efforts. The Division of AIDS (DAIDS) supports research programs to discover novel vaccine strategies, assess correlates of immunogenicity and of protections elicited by experimental vaccines and provides an infrastructure for the manufacturing and testing of novel products. To achieve this goal, the Government anticipates awarding Indefinite Delivery/Indefinite Quantity (IDIQ) contracts to multiple Contractors that meet the overall qualifications for individual Task Areas. There are two current single-award IDIQ contracts that provide preclinical services for HIV Vaccine efforts ranging from initial product discovery through full current Good Manufacturing Practices (CGMP) manufacturing and readiness for clinical trials and/or product licensure. Contract No. HHSN272201700010I, with Advanced BioScience Laboratories, Inc. (ABL), entitled “NIAID Preclinical Development Support” was awarded in June 2017 as a single award IDIQ type contract for a period of seven years (6/10/2017 through 6/9/2024) and a maximum quantity of $318,500,000.00. Contract No. HHSN272201600011I, with the International AIDS Vaccine Initiative (IAVI), entitled “NIAID Process and Analytical Support for Development of HIV Vaccines” was awarded in July 2016 as a single-award IDIQ type contract for a period of seven years (7/15/2016 through 7/14/2023) and a maximum quantity of $98,587,183.00 The current Contractors have provided preclinical services including: manufacturing feasibility assessments, analytical characterization and method development, audits, regulatory documentation, process development and current Good Manufacturing Practices (CGMP) manufacturing, and safety and immunogenicity studies. Additional services have included project management, technical support, quality assurance, product shipping and storage, and document management. NOTE: Task Area G, Scientific, Quality, And Regulatory Support Services, is set aside for small business concerns only. Proposals received from others will be considered non-responsive. The North American Industry Classification System (NAICS) code for this acquisition is 541715 with a size standard of 1,000 employees. Purpose and Objectives The purpose of this solicitation is to award multiple IDIQ contracts to support the full range of activities for preclinical and translational support services from initial product discovery through full (CGMP) manufacturing and readiness for clinical trials and/or product licensure. Changes to the contract requirements from previous IDIQ single-award competitions include use of the multiple award structure and incorporating activities currently found in the Essential Core Activities Task Area into each Task Order in the new awards. Project requirements The Contractor shall provide NIAID with a broad and flexible range of capabilities that are required for preclinical and translational development support for promising vaccines and related products for HIV and other candidate agents. The Contractor shall provide the support and services needed for all stages of process and product development, small-scale production, preclinical testing and documentation leading to Investigational New Drug (IND) submissions for Phase I, II, and III clinical testing. These capabilities will allow NIAID to rapidly and efficiently address development and production gaps. The contract will support tasks in the following areas: • Research and Development Product Storage and Shipping (Task Area A) • Safety and Immunogenicity Studies (Task Area B) • Feasibility Studies and Early Manufacturability Assessments (Task Area C) • Analytical Characterization and Method Development (Task Area D) • Process Development, CGMP Manufacturing, and Stability (Task Area E) • Fill-Finish, Packaging, and Labeling (Task Area F) • Scientific, Quality, and Regulatory Support Services (Task Area G) These contracts will be primarily used to support activities related to HIV vaccine (s) and other candidate agents. However, other NIAID programs may initiate Task Orders under these contracts as necessary to help accomplish the mission. A. GENERAL TASK ORDER REQUIREMENTS The following requirements shall apply to specific Task Orders, as needed. Individual Task Orders will include the requirements appropriate to the Task: 1. Within 30 calendar days of initiation of a Task Order, provide to the Contracting Officer’s Representative (COR): a. A Project Plan with key development objectives and milestones, proposed timelines for achieving Task Order objectives with milestones, task-linked budgets, and overall high-level steps necessary to define, prepare, coordinate, and integrate the various activities for successful execution of the Task Order; b. A plan to manage Intellectual Property (IP) that may pre-exist or will be developed during performance of the work, including the assignment of such IP rights, obtaining concurrence from the interested parties, and maintenance of security for confidential and/or proprietary data. The plan shall include coordination with third-party providers of proprietary products or data through the Task Order and Material Transfer Agreements (MTAs), if needed; c. The Contractor and all subcontractors/consultants will be required to provide access to any Subject Inventions made using third-party proprietary materials, reagents, specimens, products or data and to maintain the confidentiality of proprietary data provided to them as a result of the contract; d. A plan for disposition of data or products developed under Task Orders in consultation with the COR; and e. A Quality Management Plan consisting of, at a minimum, the following: acceptance criteria for each deliverable, procedures and process controls for each deliverable, roles and responsibilities of personnel involved, and assurance that the established procedures and processes are followed. 2. PROJECT MANAGEMENT The Contractor shall: a. Provide and implement overall project, technical, and quality management to successfully coordinate, communicate, integrate, and perform all activities. b. Assist with coordination of shipments as needed. Receive, retrieve, package, and ship products to various domestic and international locations under optimal shipping conditions to maintain product integrity and under CGMP conditions or as otherwise directed by the COR. Packaging and shipping shall adhere to U.S. and/or international standards as appropriate. Products should be stored prior to shipment at appropriate temperatures and conditions. c. Participate in meetings and provide support to organize and coordinate meetings. d. Subcontract Award and Management: Provide acquisition and management services related to the award and management of subcontracts and consultant services as follows: 1) Research and identify qualified consultants and contractors. 2) When required, develop solicitations to include a Statement of Work, milestones, deliverables and reporting requirements as well as evaluation criteria. 3) Upon receipt of proposals, perform cost and technical analyses of proposals received. Provide all of the information to support selection for award to the Contracting Officer (CO) and request to subcontract. The CO must consent to the subcontract prior to the Contractor entering into an agreement with the subcontractor. 4) Solicit, execute and manage subcontracts, including financial monitoring, tracking of deliverables and reporting requirements as well as subcontractor performance and achievement of milestones. Deliver monthly reports on progress and expenditures to the COR. 5) The period of performance of each subcontract cannot exceed the period of performance of the Task Orders. e. Provide operation and administration documents, such as meeting agendas, meeting minutes, and project timelines. The Contractor shall provide meeting agendas at least 1 business day in advance of meetings. The Contractor shall provide meeting minutes no more than 2 business days following a meeting. Meeting minutes shall include relevant information such as: key discussion points, decisions, and action items with corresponding due dates. f. Provide and upload to the NIAID electronic Report Deliverable Submission (eRDS) Site all electronic progress reports on a schedule specified in individual Task Orders and provide ad hoc reports as requested by the COR. 3. QUALITY ASSURANCE/QUALITY CONTROL. The Contractor shall: a. Provide a Quality Assurance Unit (QAU) that is independent of other operations of the Contractor, to assure that products and services are in compliance with U.S., Federal, State, and local government and International regulations, as applicable. b. Provide Quality Assurance/Quality Control (QA/QC) oversight for the activities at the Contractor’s site and/or Subcontractor’s sites. QA/QC infrastructure must include Standard Operating Procedures (SOPs) for establishing and maintaining the QA/QC processes and approaches/methods to document, identify the source (s) of and address QA/QC-related problems and deviations as they occur, as well as recommendations for the resolution, correction, and prevention of problems and deviations. 4. Provide support for a wide range of QA related document development, maintenance, and submission. 5. PERSONNEL AND PHYSICAL INFRASTRUCTURE. As required for all studies conducted under these Task Areas, the Contractor shall: a. Provide safe biocontainment facilities and resources and conduct work with hazardous biological materials in compliance with the Biosafety in Microbiological and Biomedical Laboratories (BMBL), 5th Edition. b. Where applicable, address conflicts between biosafety and clean facility requirements. 6. ACQUISITION, CARE, AND HOUSING OFANIMALS As required for all animal studies conducted under these Task Areas, the Contractor shall: a. Acquire, as necessary, sufficient numbers of animals to carry out the specific task order. The decision of which animal species, ages, and sexes to be used and any requirements for Specific-Pathogen Free (SPF) animals shall be made jointly by the COR and the Contractor, with the COR having final approval. b. House and maintain the animals in well-equipped facilities with Association for the Assessment and Accreditation of Laboratory Animal Care (AAALAC) International Accreditation or the equivalent. c. Comply with all applicable laws, policies, and guidelines regarding the care and use of laboratory animals, including the Public Health Policy (PHS) Policy on the Human Care and Use of Laboratory Animals. d. Provide to the COR and the Contracting Officer (CO) verification of Office of Laboratory Animal Welfare (OLAW) Assurance and Institutional Animal Care and Use Committee (IACUC) approval of protocols to be performed, prior to commencing any work involving laboratory animals. 1) All activities supporting specific regulatory requirements shall be conducted in compliance with Good Laboratory Practice (GLP; 21 CFR 58), CGMP; 21 CFR 210-22, International Conference on Harmonization (ICH) guidelines, or other local, state, federal, or non-U.S. product quality and development regulations, as required. For FDA submissions, this shall require performance of studies at a level of quality that is sufficient for incorporation into pre-Investigational New Drug (IND), IND, and New Drug Application (NDA) documents. Although studies that support product development outside of regulatory requirements (i.e. non-GLP or non-CGMP) may also be performed, the resulting data and processes shall be well-documented and of sufficient quality to be acceptable for inclusion in an IND or NDA filing. 2) The Contractor shall upload all project deliverables to NIAID’s electronic document repository on a monthly basis. NIAID will provide the Contractor with access to a central document storage and retrieval system to upload all documents. 7. TECHNICAL REPORTS AND DELIVERABLES Deliver to the Government or its designee as requested by the COR the following upon completion of a study under each Task Order as applicable: a. Any initial product of the Task Order, such as vaccine, adjuvant, assay, or other deliverable, including product associated data; b. All products and candidate agents, including master cell banks, Bulk Drug Substance (BDS), Drug Product (DP), such as CGMP quality pilot lots, and any other products made under the Task Order; c. Labeled and inventoried paper files and electronic files covering all aspects of process development and detailed manufacturing information for all product(s) made under the Task Order; d. All data obtained from efficacy studies, including all non-proprietary animal model data; e. A complete list of accurate and updated information regarding design, development and production (including pertinent Contractor activities, computerized data files, original data), and any related information such as the Chemistry, Manufacturing and Controls (CMC) section for IND, cross-reference to Biologic Master File (BMF); f. A complete list of accurate and updated information on subcontract activities; and g. Government-owned equipment and property, as requested by the COR. B. DESCRIPTION FOR INDIVIDUAL TASK AREAS Independently and not as an agent of the Government, the Contractor shall furnish all the necessary services, qualified personnel, materials, equipment, and facilities, not otherwise provided by the Government, as needed to perform the activities outlined in each of the following Task Areas and to carry out all requirements of the contract at the time of contract award. TASK AREA A: RESEARCH AND DEVELOPMENT PRODUCT STORAGE AND SHIPPING 1. Scope of Task Area A: This Task Area includes shipment and storage of research and development products such as CGMP and non-CGMP preclinical, nonclinical, and clinical products and agents. 2. Requirements for Task Area A: The Contractor shall: a. Manage and perform the receipt, storage, retrieval, packaging and shipping of research and development products, in compliance with CGMP regulations for clinical material. Store quarantined material. The Contractor also shall manage and perform receipt, storage, retrieval, packaging and shipping of non-CGMP products as required. b. Retrieve, receive, package, and ship research and development products to various domestic and international locations under optimum shipping conditions to maintain CGMP-product integrity. Packaging and shipping shall adhere to U.S. and international standards as required. c. Provide primary or secondary labeling or label overwrapping or related activities as requested by the COR. TASK AREA B: SAFETY AND IMMUNOGENICITY STUDIES 1. Scope of Task Area B: The purpose of this Task Area is to provide support for testing HIV products or other candidate agents in clinical studies. Support may include in vitro, ex vivo, or in vivo studies in small animal models and, if necessary, in Non-Human Primates (NHP). Assays may include testing safety and immunogenicity. 2. Requirements for Task Area B: The Contractor shall: a. Manage and perform safety and immunogenicity studies and conduct tasks in accordance with all applicable and current international, federal, state, and local laws, codes, ordinances and regulations, as well as all U.S. Public Health Service Safety and Health provisions. All studies shall be performed with appropriate quality oversight to meet all applicable regulatory requirements. b. Test product(s), for safety, potency and immunogenicity (both cellular and humoral) using in vitro, ex vivo (e.g. explant tissue assays), and/or in vivo studies in small animals and, if necessary, in NHP. Conduct reproductive toxicology testing as needed. Integrate production and testing activities and perform all tests as required by regulatory agencies, or as requested by the COR, prior to clinical use and IND or Master File submission. As required, all studies shall be performed in accordance with GLP regulations (21 CFR 58) and ICH guidelines, unless otherwise specified by the COR. Although NIAID anticipates that animal studies may not necessarily be conducted under GLP, the processes and resulting data must be well- documented and of appropriate quality to be included in regulatory filings. c. Develop and perform analytical methods to support in vitro, ex vivo, and/or in vivo safety, pharmacokinetic (PK) and pharmacodynamic (PD) studies, and other preclinical and toxicological evaluations. Produce or acquire reagents as needed. All assays and processes used shall be validated and implemented with appropriate QA and QC standards. d. Perform preclinical immunogenicity evaluation of products and other agents. e. Evaluate the data resulting from the studies and provide technical project updates at intervals and in formats designated by the COR or in the Task Order SOW. Perform preclinical safety evaluation for products to be tested, including: 1) Systemic toxicity. Preclinical studies shall include dose-ranging studies of systemic toxicity as well as toxicity to potential target organs, including hematopoietic and immune systems; 2) Local site reactivity studies to include detailed clinical observations and histological evaluation of tissue at the injection or application site, or other visible lesions from biopsies or term necropsy samples; 3) Biodistribution and Integration. In the case of DNA and some vector-borne vaccines, studies may have to be performed to determine the biodistribution of the product. An integration analysis shall be performed, if the product persists above threshold levels in a tissue; 4) Genetic toxicity. In the case of DNA and vector-borne vaccine candidates or other products, pivotal GLP preclinical studies shall focus on assessment for the potential of the nucleic acid vaccine to recombine with endogenous host DNA sequences and integrate into host chromosomes. Studies designed to address the potential for integration shall use the most sensitive methods available; 5) Tumorigenicity studies. May be appropriate under certain conditions; for example, if the preclinical genetic testing demonstrates evidence of integration activity and/or broad tissue distribution; 6) Reproduction toxicity studies. Shall be performed prior to the use of products in pregnant women. Such studies shall include fertility, general reproductive performance, teratogenicity and developmental toxicity; 7) Evaluation of the safety of adjuvants included in product formulation; and 8) Any other studies as required by regulatory requirements. f. Provide to the COR or to a COR-designated third party, all data, information and reports required for the writing and submission of the Chemistry, Manufacturing and Controls (CMC) information, ICH Quality documents, Master File, and all other documents related to pre-IND and IND submissions or for submission to regulatory authorities. Provide a CMC section for pre-IND and IND documentation as directed by the COR. Provide documentation for all regulatory submissions using appropriate formats for submission to Regulatory Agencies such as the FDA or other non-U.S. regulatory authorities. g. Retain and appropriately store records and specimens that were analyzed to prepare the reports per GLP guidance TASK AREA C: FEASIBILITY STUDIES AND EARLY MANUFACTURABILITY ASSESSMENTS 1. Scope of Task Area C: The purpose of this Task Area is to assess and provide recommendations on products and processes developed for testing HIV products and other candidate agents or specimens for the following attributes, such as: feasibility of design, development, support and assessment of early manufacturability, transfer of product attributes and characteristics, development of potency assays, and short-term stability. 2. Requirements for Task Area C: The Contractor shall perform Feasibility Studies and Early Manufacturability Assessments for the development of products to test HIV vaccine and other candidate agents in clinical trials. Specifically, the Contractor shall: a. Assess the current status and overall scientific feasibility of the studies to be performed under a Task Order. b. Review all relevant documents related to the project’s history, including current scientific documents related to the project, such as laboratory notebooks, publications, and any ancillary documentation, including regulatory documentation. c. Assess early manufacturability. Support transfer of product attributes activities and perform pilot studies when needed. d. Assess the traceability of all reagents and the requirements for QA, as needed. e. Assess and advise on the current status and overall scientific feasibility of the project by performing the following: 1) After review, provide the product development history, including current scientific documents related to the project, laboratory notebooks, publications, and any ancillary documentation and regulatory documentation; 2) Provide the manufacturing feasibility and traceability of all study reagents; 3) Complete, provide guidance, and/or assist with transfer activities for product attributes and characteristics; 4) Provide the financial feasibility of the proposed project; and 5) Provide gap analysis and risk assessments. f. Develop Product Development Plans (PDP) and/or feasibility studies for candidate products as directed by the COR. Plans shall, at a minimum, include regulatory, pre-clinical, non- clinical, clinical, and manufacturing activities to be undertaken for a product. g. Provide other feasibility study details as included in specific Task Orders. h. Perform additional requirements related to the PDP as described in specific Task Orders. i. Manufacture feasibility lots of each formulation in quantities appropriate to confirm the third- party formulation methods. The feasibility lots shall be prepared at a scale appropriate for scale-up to the target batch size. j. Before completion of the Task Order, and prior to a date that has been discussed and determined with the COR, the Contractor shall deliver all manufactured feasibility lots and target batches of each formulation and all related documentation. TASK AREA D: ANALYTICAL CHARACTERIZATION AND METHOD DEVELOPMENT 1. Scope of Task Area D: This Task Area will support activities for the development of analytical methods for product characterization and optimization, QC, from product release and stability program through final formulation, with or without adjuvants. This Task Area includes performance of assays needed for product characterization, to support all phases of product development and to fulfill regulatory requirements as directed by the Task Order. 2. Technical Requirements for Task Area D: These services include analytical method development, method transfer and validation, and/or performance of the method with appropriate QA oversight to meet all applicable regulatory requirements. Specifically, the Contractor shall: a. Develop or acquire methods to evaluate both the structure and function of HIV vaccine or other candidate agents, and assure that products maintain the key product attributes through all stages of production, including upstream, downstream and through final formulation with or without adjuvant (s); b. Manage, develop and conduct analytical characterization methods to assess the physicochemical structure and biological activity of HIV immunogens or other vaccine candidates or agents. Methods may include cryo-electron microscopy, Surface Plasmon Resonance (SPR) and/or Biolayer Interferometry (BLI) 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 (MS); c. Develop and evaluate novel methods for suitability as product characterization or QC assays: 1) Ensure all methods developed for QC purposes have the required level of qualification/validation for the intended phase of development (see International Council for Harmonization (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); 2) Ensure assays are supported by appropriate scientific rationale and are appropriately documented based on guidance by FDA and other regulatory agencies; d. Develop and/or provide assays and reagents: 1) Develop and/or provide assays for evaluation of products with cells and/or tissues from relevant models/species. 2) Develop relevant diagnostic or immunological assays that may include the following: a) Quality testing of reagents and animal model parameters, as appropriate; b) Development of positive, negative, and sham control samples; c) Optimization of assays; d) Qualify and/or validate, as requested by the COR, assays and reagents; e) Other studies to explore whether new assays or procedures are meaningful for the intended purpose as directed by the COR; f) Acquire, produce or expand reagents as needed to support in vivo, ex vivo and in vitro assays after receiving approval by the COR. The Contractor may develop or produce necessary reagents either de novo or from pre-existing reagents. e. For Method Development, specifically, the Contractor shall: 1) Develop protocols for all in vitro, ex vivo, or in vivo studies, as needed; 2) Develop and perform analytical methods to support in vitro, ex vivo and in vivo safety, pharmacokinetic and pharmacodynamic studies, and other preclinical and clinical evaluations; 3) Provide all analytical services required for performance of in vitro, ex vivo, and in vivo safety and efficacy studies; 4) Develop and perform analytical methods to characterize formulatory components and proposed formulations in support of manufacturing process development, product characterization, release, stability, identity, homogeneity, and other preclinical and clinical evaluations. TASK AREA E: PROCESS DEVELOPMENT, CGMP MANUFACTURING, AND STABILITY 1. Scope of Task Area E: The Contractor shall provide NIAID with a broad and flexible range of feasibility studies to determine manufacturability of products, process and product development, product characterization, CGMP manufacturing, and optimization services for HIV vaccine candidates and other agents that support preclinical, nonclinical, and clinical studies. These services will range from initial product discovery to production and activities required to support clinical trials and/or product licensure. 2. Requirements for Task Area E: Specifically, the Contractor shall carry out tasks in the following areas: • Feasibility Studies and Process Development • Generate materials suitable for IND-enabling studies • CGMP Manufacture with or without Fill-Finish • Stability Program a. PROCESS DEVELOPMENT The Contractor shall conduct the following types of activities to support process development and fulfill regulatory requirements as directed in the Task Order SOW: 1) Process development, process transfer and validation, and/or performance of the process. 2) Analytical method development and/or performance of the method. 3) Other specific activities in support of this task area as required by relevant regulatory agencies to advance products into clinical testing. 4) The Contractor shall: a) Perform full process and product development of the candidate product: scalable upstream and downstream production and purification activities, product characterization, optimization and testing, formulation activities, stability studies and technology transfer. These may be at pilot scale, engineering scale, or CGMP manufacturing; b) Construct, screen, and optimize various products for enhanced stability, immunogenicity, and expression as well as other characteristics as directed in specific Task Orders; c) Produce or establish Master Cell Banks (MCB) and Working Cell Banks (WCB) and Master Viral Bank (MVB) from well-characterized Research Cell Banks (RCB) and Research Viral Banks (RVB), respectively, as directed; d) Characterize vaccine products, viral vectors, and other candidate agents; e) Design and develop protocols for all in vitro, ex vivo, or in vivo studies and provide to the COR, as directed; f) Develop and perform analytical methods to characterize vaccine products or other products, and other preclinical and clinical evaluations. Develop and provide QA/QC assays for in-process products; g) Provide all analytical services required for performance of in vitro, ex vivo, and in vivo safety and efficacy studies; h) Generate reagents and reference standards, develop assays, and perform analytics needed for in-process testing or release products such as potency and immunogenicity; Evaluate adjuvants, delivery vehicles, and routes of administration of candidate vaccines, as needed; i) Provide technology transfer packages. Manage successful technology transfer at least at pilot or engineering scale. Develop and provide a detailed project plan, budget, and Gantt chart for early-to-late-stage process development and manufacture of products prior to undertaking reagent-grade or pilot-lot CGMP production. The project plan shall include written SOPs for all steps in the production and purification process that are used in pilot production. 5) Although NIAID anticipates that all these studies may not necessarily be conducted under GLP, the processes and resulting data shall be well-documented and of sufficient quality to be acceptable for inclusion in regulatory filings (IND/NDA). b. CGMP MANUFACTURING AND FILL-FINISH OPERATIONS The Contractor shall perform CGMP product manufacturing, analytical support of CGMP operations, and fill-finish of Bulk Drug Substance (BDS) for HIV products and other candidate agents to produce preclinical and clinical trial material, and fulfill regulatory requirements as directed by the Task Order SOW. Specifically, the Contractor shall: 1) Manufacture products under CGMP conditions at suitable scale to include consistency lots when needed, for conducting preclinical, stability, toxicity, biodistribution, or clinical studies with verifiable safety, purity or potency of the product; 2) Provide analytical services in support of product manufacture; 3) Qualify or validate processes and assays and implement appropriate QA and QC standards for all services provided; 4) Perform audits of subcontractors or vendors, to assure facilities and all planned procedures meet the FDA-required GLP and CGMP standards; Host NIAID participants of these audits, and/or host NIAID-led audits as needed or as requested by the COR; 5) Provide all the necessary documentation and guidance required to assemble a CMC section for an IND submission; 6) Retrieve, receive, store, ship and record products and any other materials associated with the products; 7) Perform fill-finish operations of CGMP manufactured candidates including vialing, packaging and labeling, in compliance with FDA, EMA, or other regulatory agency regulations. Perform all release testing and provide a Certificate of Analysis (CoA) and Certificate of Compliance (CoC) as needed. Establish, implement and oversee product- specific stability programs that comply with FDA, ICH or other non-U.S. regulatory guidelines for CGMP-manufactured products and other candidate agents intended for human use; 8) Develop a detailed project plan and budget, in consultation with the COR, for the manufacture for each product prior to undertaking CGMP production. The project plan shall include written SOPs, list(s) of SOPs, a...
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