Call for capabilities: Establishment of a good manufacturing practice human amniotic fluid cell seed bank

Disruptive Technology Solutions for Cell and Gene Therapy Challenge program

  1. 1. Program details
  2. 2. Objectives
  3. 3. Eligible projects and teams
  4. 4. Costs
  5. 5. Funding and support
  6. 6. Application process and timelines
  7. 7. Projects and funding agreements
  8. 8. Contact information
  9. Annex A. Proposal evaluation criteria

1. Program details

The National Research Council of Canada's (NRC) Disruptive Technology Solutions for Cell and Gene Therapy Challenge program is launching a call for proposals to create collaboration opportunities between the NRC and the broader research community. Collaborations would unify the value chain for engineered cell and gene therapies, from discovery to commercialization.

In 2018, the NRC launched the challenge program to develop a collaborative framework by aligning with multiple partners and collaborators from various sectors, to address critical health challenges facing Canadians.

1.1 Vision and mission

The program's vision is to transform health outcomes for Canadians with cancer and genetic diseases. Our researchers use synthetic biology-driven innovations in engineered cell and gene therapies to bring this vision to life.

The program's mission is to develop technologies, platforms, cell lines and collaborative models that will speed up development and enable the delivery of safe, accessible and affordable cell and gene therapies in Canada.

Considering the many barriers to the cost-effective development and clinical delivery of personalized cell and gene therapies to Canadian patients, the program will collaborate with the Canadian cell therapy and regenerative medicine community to establish a human amniotic fluid cell (hAFC) seed bank. This will be done under good practices compliance for use as starting material for therapeutic product development.

2. Objectives

The primary objective for this funding opportunity within the Disruptive Technology Solutions for Cell and Gene Therapy Challenge program is to harness the potential of human induced pluripotent stem cells (iPSCs) as a renewable and scalable cell source to develop cell-based therapeutic products for regenerative medicine and immunotherapy applications.

Human amniotic fluid derived cells (hAFCs) provide a unique opportunity to access fetal derived cells with potential unique properties and stem-cell like attributes, making these cells more responsive to reprogramming into iPSCs compared to adult donor sources.

The NRC is interested in leveraging this unique fetal donor cell source, acquired during routine amniocentesis, to establish good manufacturing practices (GMP)-compliant seed stock biobanks for future use in the development and commercialization of regulatory compliant hAFC and hAFC-iPSC based therapeutics.

We have a long history and expertise in working with hAFCs and hAFC-derived iPSCs, demonstrating their robust differentiation capabilities into a number of clinically relevant cell types (i.e. neurons, natural killer cells, endothelial cells, cardiomyocytes).

We will work collaboratively with the successful applicant to establish a good practices compliant hAFC seed stocks as a source of donor cells for the future development of high-quality human iPSCs for use in research development, clinical and commercial applications.

Providing the Canadian and international life science research ecosystem with access to such a hAFC seed stock biobank will help overcome the prohibitive accessibility and affordability barriers that limit translational research and promote the development of made-in-Canada stem-cell based therapeutics.

3. Eligible projects and teams

Collaborators working with the NRC who are eligible for funding under this call:

  • Canadian small and medium-sized enterprises (those with fewer than 500 employees)
  • Not-for-profit research organizations
  • Research institutions
  • Academic institutions

Requirements:

Note: Un-funded collaborators and subcontractors from across the technology ecosystem may also collaborate on projects.

3.1 Commitment to EDI and GBA+

Project teams must clearly demonstrate their commitment to equity, diversity and inclusion (EDI) and gender-based analysis plus (GBA+) in their research applications, including composition of their project teams, research methods, analysis and knowledge-mobilization plans. Undertaking GBA+ and critically considering factors related to EDI adds valuable dimensions in research and improves the quality, social relevance and impact of the research.

In addition, it may contribute to taking the research in a new direction. EDI and GBA+ considerations should influence all stages of research or development processes, from establishing priorities and building theory to formulating questions, designing methodologies and interpreting data. Applicants are invited to consult the guide to best practices in equity, diversity and inclusion in research practice and design.

4. Costs

Eligible costs:

  • Salaries for highly qualified personnel working on the project activities
  • Research support costs (direct costs incurred in the project implementation phase), including:
    • consumable materials
    • supplies
    • equipment rentals
    • facility rentals
  • Costs for on-duty travel required to execute the project and limited conference travel (for highly qualified personnel)
  • Amounts invoiced to the applicant by a contractor for services rendered relating directly to the project (professional services fees)
  • Indirect costs that are not directly applicable to carrying out the project but are necessary to conduct the recipient's general business, up to a maximum of 10% of total eligible costs
  • Equipment costs
    • Laboratory equipment and other components, generally between $10k and $50k

Equipment costs must not exceed 25% of the Collaborative Science, Technology, and Innovation Programs supported project funding. Applicants must demonstrate that the project objective may not be achieved without this equipment and that equipment can be procured in a reasonable timeframe.

Costs not covered:

  • Purchase of land
  • Leasehold interest
  • Property taxes
  • Any portion of costs subject to refunds, rebates or credits, including HST, GST and PST
  • Costs paid by the NRC

5. Funding and support

Funding provided by the National Program Office follows the terms and conditions of the Collaborative Science, Technology and Innovation program. This program is intended to position the NRC as a collaborative platform that uses science excellence to respond to Canada's most pressing challenges.

As such, projects supported under this initiative benefit from NRC assets in place (special-purpose research facilities, scientific expertise and networks) and financial assistance in the form of non-repayable grants or contributions.

For more information on available funding, consult the grant and contribution funding for collaborators webpage.

The program is planning to make $250,000 available to support 1 project under this call with a 1:1 matching contribution (cash or in-kind) from the selected collaborator.

All deliverables must be addressed and the funding must be spent by the end of the program on March 31, 2026. There will be no project extensions beyond this date.

5.1 Stacking provisions

The stacking provisions for projects are as follows:

  • The maximum limit of the total Canadian government assistance (federal, provincial, territorial and municipal assistance for the same eligible costs) cannot exceed 100% of the total eligible project costs
  • The maximum NRC cost share will not exceed 50% of total eligible project costs

6. Application process and timelines

The NRC is committed to a consistent, fair and transparent selection process to identify, select and approve the allocation of funding to projects that best fit the objectives of the collaborative call.

Proposals will be assessed based on the following technical requirements and the criteria provided in Annex A.

6.1 Technical requirements

Applicants must clearly demonstrate in their proposal how they meet each of the following requirements:

  • Expertise to collect, expand, store and manage the inventory of the human amniotic fluid cell (hAFC) seed stocks from a hospital where routine amniocentesis is performed as standard of care for expectant mothers
    • This includes acquiring all the necessary hospital permissions and informed consent forms to access medically suitable donors, adhering to all ethical and legal guidelines related to the collection and banking of hAFCs, especially regarding the potential future uses of the hAFCs, including but not limited to commercial use
      • The applicant may subcontract hAFCs collection and related processes and approvals to a partner tissue recovery agency, if desired
    • The informed consent must be reviewed and approved by the NRC prior to initiating collections
  • Expertise to collect, expand, store and manage the inventory hAFC seed stocks under strict good practices compliant processes to satisfy future GMP-compatible cell therapy development in accordance with the regulatory standards and guidelines set forth by Health Canada (as well as other regulatory standards and guidelines from other regulatory agencies such as, but not limited to, the FDA, EMA, MHRA and PMDA)
  • Expertise to perform all required testing as set forth by Health Canada regulations including, but not limited to, microbial and adventitious agents and viral safety (hepatitis B and C, HIV, HTLV, CMV and EBV) on the established hAFC seed stocks
  • Expertise to establish 2 healthy female and 2 healthy male hAFC seed stocks using the following criteria:
    • The hAFCs have a normal genetic karyotype screening analysis
    • The hAFCs are proliferative (doubling time approximately 30 to 40 hours) and can be passaged in culture (up to minimum 5 passages)
    • The banked hAFCs are viable post-thaw (≥50% viability) with recoverable attachment 24 hours after plating and successful growth to confluency
    • The hAFCs are negative for bacterial, fungal and mycoplasma contamination
  • Acknowledgement that multiple hAFC collections, expansion and banking attempts may be required, from different donors, before 2 healthy female and 2 healthy male hAFC seed stock are successfully established, as per the above criteria
  • Expertise to expand the hAFCs and establish a minimum of 10 vials (1 million cells each) to generate an hAFC seed stock
  • Ensure that 3 vials of the hAFC seed stock are kept in reserve to ensure sustainability of stocks
  • Expertise to reprogram a minimum of 1 male and 1 female hAFC seed stock to induced pluripotent stem cells (iPSC) to generate a research grade iPSC line for broad distribution to the Canadian research ecosystem
  • Expertise to store and manage the hAFC seed stocks at a site in Canada, under adequate storage and management to ensure traceability
  • Expertise to provide access to hAFC seed stock vials to interested parties for future product development upon formal request and written consent from the NRC

6.2 Key dates and deadlines

  • November 15, 2023: Call opens
  • December 8, 2023: Q&A with the NRC research team (requires registration)
  • January 22, 2024: Full proposal submission deadline
  • April 2024: Successful projects move to the next stage

6.3 Registration

Register for this call and the Q&A session by sending an email to NRC.HealthProgram-ProgrammeSante.CNRC@nrc-cnrc.gc.ca.

7. Project and funding agreements

After receiving the notice of project approval, applicants must enter into a collaborative research agreement with all project collaborators or a funding agreement (non-repayable transfer payment) with the NRC. If an agreement cannot be finalized within a reasonable timeframe, funding may be cancelled.

8. Contact information

For more information on this specific collaboration opportunity with the Disruptive Technology Solutions for Cell and Gene Therapy Challenge program, please send an email to: NRC.HealthProgram-ProgrammeSante.CNRC@nrc-cnrc.gc.ca

Annex A. Proposal evaluation criteria

The proposals will be assessed using the following criteria.

Team composition

  • The project team has an applicant principal investigator from an organization that is eligible to receive funding from the NRC
  • The project team includes an eligible hospital or partner tissue recovery agency collaborator
  • Principal investigators are identified from each collaborating organization and their role in meeting the project deliverables is clearly defined
  • The project team clearly demonstrates, with supporting evidence, good manufacturing practice cell banking expertise and experience under compliant processes in accordance with the regulatory standards and guidelines set forth by Health Canada (as well as other regulatory standards and guidelines from other regulatory agencies; see section 6.1)
  • The project team clearly demonstrates, with supporting evidence, expertise in induced pluripotent stem cell reprogramming

NRC collaboration

  • The project aligns with the NRC's key research areas, such as human amniotic fluid cells, human induced pluripotent stem cells and engineered cell-based therapies
  • The collaboration leverages the NRC's assets and resources, including scientific expertise, networks and research facilities
  • The collaboration is feasible in terms of implementing the NRC's technologies and expertise towards achieving the project's objectives

Alignment

  • The project aligns with the objectives of the Disruptive Technology Solutions for Cell and Gene Therapy Challenge program, particularly in terms of overcoming the prohibitive accessibility and affordability barriers that are limiting translational research
  • The project has a sound research approach and rigorous good manufacturing practice documentation
  • The project description fits within the available timeline
  • The project supports the attainment of benefits for Canada

Quality

  • There is a proposed pathway to therapeutic development and commercialization or widespread public utility and impact of the HAF seed stock or derivatives thereof

Eligibility

Funding

  • Adequate rationale is provided for financial assistance of the recipient
  • The funding recipients are eligible based on the Collaborative Science, Technology and Innovation program guidelines
  • The applicant team can commit a minimum of 1:1 matching funds (cash or in-kind)
  • The project costs are eligible

From: National Research Council Canada

 
 
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