National Institute of Allergy and Infectious Diseases (NIAID)
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.
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.
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:
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. 5. 5) 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 OF ANIMALS
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:
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, and protocols that are established and followed for all steps in the sterile or aseptic production and purification process for CGMP manufacture as well as the fill-finish of the product;
9) Provide information pertaining to the composition, manufacture, and quality control of the product, as appropriate, for particular investigations carried out under an IND;
10) Retain all records, samples, and histology/microscopy slides, as indicated under GLP and CGMP guidelines, and provide them to the COR upon request;
11) Produce or acquire any reagents necessary for testing or evaluating the immune responses to products;
12) Establish, implement and oversee formulation studies for manufactured vaccines and/or products as requested by the COR;
13) Deliver to the Government, upon request, any initial product of the Task Order, such as a vaccine, adjuvant, assay, or other deliverable, including the product’s associated data.
c. STABILITY PROGRAM
1) Design and perform stability testing program on BDS and or Drug Products (DP), and if needed, conduct pre-formulation and/or formulation studies or tests on vaccine candidates or drug product-adjuvant interactions, or combinations thereof.
2) The Contractor shall perform stability testing of BDS and DP based on long-term, real-time and real-conditions of storage. This stability testing will help establish recommended storage conditions, retest periods, and shelf life of the candidate products.
TASK AREA F: FILL-FINISH, PACKAGING, AND LABELING
1. Scope of Task Area F: The purpose of this Task Area is to perform fill and finish including packaging and labeling of products and other agents.
2. Requirements for Task Area F:
Specifically, the Contractor shall:
a. Perform fill-finish operations, packaging and labeling: Conduct aseptic fill-finish of candidate products for pre-clinical, stability, and clinical studies. Fill-finish operations shall include all necessary in-process and release testing, qualified assays, appropriate components, formulation, vialing, labeling, packaging, and storage. Final fill-finish operations may be preceded by Contractor’s assistance in the design and execution of pre-formulation and formulation development studies and/or supporting media fills when needed. All these operations shall take place at CGMP-compliant facilities by methods that meet standards for products appropriate for use in clinical trials, as described in the Code of Federal Regulations (CFR) “Sterile Drug Products Produced by Aseptic Processing—Current Good Manufacturing Practice”, “Current Good Manufacturing Practice for Finished Pharmaceuticals” 2l CFR parts 210 and 211, or other non-U.S. regulatory agencies.
b. Ensure feasibility and appropriateness of the proposed plans and operating procedures for receipt, storage at designated temperature, custom blending, and/or formulation studies using BDS, vialing, labeling, retrieval, packaging, and shipping of filled products, materials, and specimens required to fulfill the SOW.
c. Provide formal, written procedures, SOPs, draft and final batch records related to fill-finish,
any bridging or qualification studies, DP testing, product release specifications, facilities- compliance, validated sterilization of components or processes, and container-attributes or container-closure information.
d. Perform labeling of CGMP-filled candidate vaccine products as needed, in accordance with CFR Title 21, Vol 5, Part 312.
e. Perform all release testing and provide a CoC and CoA, as needed.
f. Conduct other specific activities related to fill-finish, packaging and labeling to advance products into clinical testing per FDA or other non-US regulatory guidance.
TASK AREA G: SCIENTIFIC, QUALITY, AND REGULATORY SUPPORT SERVICES
THIS TASK AREA IS SET ASIDE FOR SMALL BUSINESS CONCERNS (see above)
1. Scope of Task Area G: The scope of this Task Area is to provide broad scientific/technical, QA/QC, Regulatory, and other clinical or related research support for products and other candidate agents as directed by the COR.
2. Requirements for Task Area G:
Specifically, the Contractor shall:
a. SCIENTIFIC AND TECHNICAL SUPPORT
1) Provide scientific and technical support for areas such as: temperature excursions during shipping and storage, product integrity, Out-of-Specification (OOS) test results, Compliance Events (CE), reports of particulate matter in BDS, DP or other materials including adjuvants, and evaluation and interpretation of data, or as requested by the COR.
2) Provide subject matter expertise when requested by the COR for strategic technical planning in other Task Areas such as cell line development, harvest and yield optimization, purification, stabilization, formulation, adjuvants, process refinement, existing, novel and emerging platform and technology development, and compliance issues.
b. QUALITY ASSURANCE/QUALITY CONTROL (QA/QC) SUPPORT
1) Provide Audit Support:
a) Conduct and manage facility audits and/or technical audits of foreign and domestic vendors. Audits shall consider compliance with:
i. Domestic and non-domestic laws and regulations,
ii. FDA/European Medicines Agency (EMA) regulations and guidance, including those required to meet CGMP, GLP guidance, GCP standards and/or other applicable guidance, and
iii. NIAID policies and the terms of the contract.
b) Specifically, the scope of the audit may include activities such as: organization and personnel, buildings and facilities, equipment, control of components and BDS Substance and DP containers and closures, production and process systems and controls, packaging and labeling control, holding and distribution, laboratory controls, returned and salvaged drug products, testing facilities operation, test and control articles, protocols for and conduct of a non-clinical laboratory or toxicity study, records and reports, and disqualification of testing facilities.
c) Provide to the COR an audit plan within ten (10) business days of a request for an audit. Provide to the COR a draft of the audit report within ten (10) business days of audit completion. The Contractor shall submit the final audit report to the COR within twenty-one (21) business days of audit completion and provide prioritized recommendations to address observations and/or deficiencies identified in the report. Upon approval of the report by the COR, the Contractor shall provide a copy to the audited organization’s representative.
d) Establish and maintain a Conflict of Interest (COI) policy and SOP that addresses reporting chain independence of auditors from other contract related staff and independence from the sites to be audited. The COR will review the draft COI SOP and provide comments to the Contractor within ten (10) business days of receipt. Provide the final COI SOP within twenty (21) business days of Task Order award date. Report any identified conflicts of interest prior to any site visit or audit.
2) Provide other quality support and guidance as requested by the COR.
c. REGULATORY SUPPORT
Document preparation and submission: In consultation with the COR, obtain and compile information necessary for submission of regulatory documents to the U.S. or non-domestic regulatory authorities.
1) Compile and assemble all documentation required for the pre-IND, IND and other regulatory submissions, in a format appropriate for submission to the FDA, EMA, or other regulatory agencies, upon request from the COR. Compile and provide a CMC section for pre-IND and IND documentation as requested by the COR. Participate in discussions with the FDA or non-U.S. regulatory agencies when required.
2) Provide additional submissions and amendments to the COR or to a third-party designated by the COR, as necessary for successful filing of the IND, or comparable non-
U.S. approval documents. Prepare an environmental assessment as described in 21 CFR 25.31, if required.
3) Review documentation as requested by the COR, and provide regulatory support related to all aspects of the product pathway for vaccine candidates or other agents: safety and immunogenicity studies, process and product development, manufacturing, fill/finish, and stability.
4) Provide other regulatory support services as directed by the COR.
Anticipated Period of Performance
NIAID anticipates that multiple Indefinite Delivery/Indefinite Quantity (IDIQ) contract awards for the Base contracts will be on or about June 9, 2021. The ordering period for these contracts will be from June 9, 2021 through June 8, 2028. Contractors will not be required to make any deliveries under the contracts after June 8, 2031.
The Government anticipates awarding the following number of Task Orders each year. This list is provided to indicate the general scope of the work to be performed and should be considered an estimate only.
Estimated No. of
Task Orders Per Year
Research and Development Product Storage and Shipping
2 awards will be made for a 7 year period of
Safety and Immunogenicity Studies
Feasibility Studies & Early Manufacturability
Analytical Characterization and Method Development
Process Development, CGMP Manufacturing and Stability
Fill-Finish and Labeling
Scientific, Quality and Regulatory Support Services
Immediately, upon award of the Base contracts for this multiple award IDIQ, the Government anticipates awarding two Task Orders as follows:
Task Order #A -1, Research and Development Product Shipping and Storage
We anticipate awarding a cost-reimbursement, level of effort/term type Task Order. The period of performance of this Task Order will be June 9, 2021 through June 8, 2022. The requirement will be the delivery of 1.45 Full Time Equivalents (FTEs) for the base period (Year 1). Options to extend the term of the Task Order will be included in the Task Order award. Assume that the scope and types of activities as outlined herein (i.e., for year one of the Task Order) would be continued for each succeeding annual Task Order period up to 7 total years. If Options to extend the term are exercised, the Contractor shall provide
1.45 FTEs per year for Options 1 and 6. Please note that the number of FTEs is inclusive of subcontractor and consultant effort.
Level of Effort: Below is the level of effort required for this Task Order. The level of effort is stated in terms of FTEs. The labor mix is provided as an estimate and is not meant to be restrictive. The Contractor may propose a different labor mix for carrying out the SOW of the Task Order but must meet the total FTE requirement.
Offerors may respond to one Task Area only, to several Task Areas, or to all Task Areas. Task Area G, Scientific, Quality and Regulatory Support Services, is set aside for small business concerns only.
Any responsible offeror may submit a proposal which will be considered by the Agency. This RFP will be available electronically on/about April 10, 2020 and may be accessed through beta.SAM.gov. This notice does not commit the Government to award a contract or Task Order. No collect calls will be accepted. No facsimile transmissions will be accepted.
For this solicitation, the NIAID requires proposals to be submitted via the NIAID electronic Contract Proposal Submission (eCPS) website. For directions on using eCPS, go to the website at https://ecps.nih.gov and then click on “How to Submit.” Submission of proposals by facsimile or e-mail is not acceptable.
AIDS Research Contracts Branch, Office of Acquisitions
Division of Extramural Activities
National Institute of Allergy and Infectious Diseases
National Institutes of Health, DHHS
5601 Fishers Lane, Room 3C29, MSC 9821
Bethesda, MD 20892-9821
For Express Mail, change zip code to 20852
John R. Manouelian
AIDS Research Contracts Branch, Office of Acquisitions
Division of Extramural Activities
National Institute of Allergy and Infectious Diseases
National Institutes of Health, DHHS
5601 Fishers Lane, Room 3C31, MSC 9821
Bethesda, MD 20892-9821
For Express Mail, change zip code to 20852