Accelerating Inline Sensing for Cell Therapy Biomanufacturing Solicitation FAQs
General
What is the purpose of this program?
The program seeks inline sensing systems that provide real-time, non-destructive measurements of critical quality attributes (CQAs) from within the cell therapy manufacturing process. The goal is to support earlier detection of process deviations and generate continuous biological data that can improve manufacturing consistency and support future automation.
Is this an NIH grant application?
Operating under a contract with the NIH, solicitation, review, and oversight of the program is coordinated by the Cimit as the RADx Coordination Center with award contracts issued by the RADx Award Management Center.Awards comply with NIH policies, but this application does not count toward the NIH application limit.
Is this a standard NIH R01?
No. This program operates through the RADx Innovation Funnel. The solicitation specifies the funding instrument used by NIH. Deep Dive due diligence precedes award finalization.
What is the “Deep Dive”?
The Deep Dive is a hands-on, interactive due diligence stage and the final stage of review before funding decisions. Applicants work with an RADx mentor to:
- Assess the prototype technology across the evaluation criteria.
- Identify key risk factors and establish ways to mitigate them.
- Finalize a milestone work package and budget with objective go/no-go criteria across technology, clinical use context, regulatory, and market/manufacturing domains.
Who do I contact if my question isn’t addressed in the FAQ?
Please send an email to TBD.org
Submission
Do you have any accessibility accommodations for applications?
Please email cimitcommunications@partners.org for instructions if your input devices are having trouble with the submission system. No material can be submitted directly to program staff, but staff can provide assistance.
Where and when do I submit?
Submit through the Cimit online system at [add submission portal link] by 5 PM Eastern, January 25, 2027. Applications open on December 8, 2026. The program will use a single posted submission deadline and reserves the option to extend it to ensure a competitive pool.
Can I submit a video?
Yes. You may submit an optional ≤3-minute video link. It must complement (not replace) the 3-page supporting PDF(s). The video must support the technical and data requirement and not be a marketing video.
May I include references?
You can include as many references as you would like.
Should I submit copies of relevant publications?
No. Do not submit copies of relevant publications. All cited references should be readily available to reviewers through usual search mechanisms. Please do not submit copies of relevant publications. Standard citation of publications is acceptable.
Will I get feedback?
Limited feedback may be given if your application is not selected. Detailed feedback will be provided during Deep Dive if your application advances.
What other guidance is there for submission?
We will not consider applications that are either substantially developed by AI, or contain sections substantially developed by AI. Submissions should include original ideas of applicants. For more information see the notice “Supporting Fairness and Originality in NIH Research Applications”.
Eligibility
Who is eligible to apply?
Eligible applicants include for-profit (small or large business) entities, non-profit organizations, public or private institutions of higher education, and consortia thereof. Applicants must be domestic (U.S.) entities with a permanent U.S. address; non-domestic (non-U.S.) entities are not eligible to apply as the prime applicant.
Is concurrent SBIR/STTR or other federal funding for the same work allowed?
An applicant may have multiple applications and/or awards involving the same underlying technology, provided the proposed work does not constitute scientific, budgetary, or commitment overlap.
Can one organization or PI submit more than one application?
Yes. However, the applications must be scientifically distinct. Duplicate or highly overlapping applications will not be accepted. Each application must represent a distinct project.
What stage of development should the technology have achieved at the time of submission?
Prototype stage or beyond. Applicants should provide an existing evidence base demonstrating sensor performance in a biologically-relevant context. This program is not intended to support concept-stage development; proposals should present prior data that substantiates the feasibility of the proposed sensing approach under conditions representative of cell therapy manufacturing, rather than relying on simplified model systems, synthetic matrices, or buffer solutions as the primary validation context.
What are the minimum entry requirements for a responsive application?
An application must meet all five requirements: propose an inline sensing approach that operates within the cell therapy manufacturing process; identify at least one defined CQA as the primary target; present prior experimental performance data in a biologically relevant context; describe compatibility with cell therapy manufacturing; and define a work plan with measurable targets, deliverables, and a milestone-based timeline. Applications missing any of these requirements will be returned without review.
What is considered non-responsive?
Applications are considered non-responsive if they:
- Represent basic discovery or early-stage research without a credible path toward translation and deployment in a cell therapy or biomanufacturing environment.
- Rely on simplified model systems, synthetic matrices, or buffer solutions as the primary validation context rather than cell therapy manufacturing–relevant conditions.
- Lack a credible validation plan against established offline reference methods for the target CQA.
- Lack a credible pathway toward commercial adoption and manufacturability.
- Include the usage of human fetal tissue or human embryonic stem cells as a cell source.
- Do not include an Authentication of Key Biological and/or Chemical Resources plan.
- Target critical process parameters (e.g., pH, dissolved oxygen, temperature, glucose) for which mature inline sensing solutions already exist.
What criteria will reviewers use?
Reviewers will evaluate sensitivity and specificity of CQA detection; temporal resolution; non-destructive measurement and biocompatibility; concordance with offline reference methods; measurement stability and reproducibility; process and integration compatibility; technical maturity and feasibility; and commercialization and adoption potential.
What are the cell sourcing requirements, for both human and non-human sources?
Applicants must include an Authentication of Key Biological and/or Chemical Resources plan addressing the identity, quality, and purity of all cells and key resources used in performance data; applications that do not include this plan will be considered non-responsive.
Established, commercially available cell lines (human or non-human) are allowable; non-commercial cell sources require the applicable determination and approvals must be in place by time of award: IRB for human material, IACUC for non-human. Applications involving human fetal tissue or human embryonic stem cells are not allowed. Applicants without required approvals at the time of application should describe their plan and timeline for obtaining them prior to award.
Does automated online sampling count as inline?
Automation alone does not establish eligibility. We require sensing from within the manufacturing process that is continuous and non-destructive. Applicants using automated sampling should confirm responsiveness with the program office and explain where measurement occurs and how product integrity is preserved.
Intellectual Property
Who retains the rights to any intellectual property generated by a proposal?
Management of intellectual property will be determined by the institutional policies of the proposing entity. This should be addressed prior to submission.
Should I disclose any unprotected proprietary information in the submission?
Protecting proprietary information is the responsibility of the applicant and the applicant institution. Consistent with NIH policy, applicants are discouraged from submitting information considered proprietary unless it is deemed essential for proper evaluation of the application. However, when the application contains information that constitutes trade secrets, or information that is commercial or financial, or information that is confidential or privileged, identify the pages in the application that contain this information by marking those paragraphs or lines with an asterisk (*) at the beginning of the paragraph or line. See more detail for the full proposal in the section below.
Budget, Awards, and Contracts
Are there salary limitations for these awards?
Yes. The current NIH guidance sets the cap at $227,000. Please see https://grants.nih.gov/policy-and-compliance/policy-topics/nih-fiscal-policies/salary-cap-summary for additional info.
What are my reporting responsibilities if I receive an award?
An annual report will be required in accordance with the terms and conditions of the award. Continuous interactions with contracted Project Leads will be required.
In addition to funding, what types of support is included in this program?
Awardees will also receive ongoing, specialized support from mentors experienced in commercializing biomanufacturing tools and/or process technologies. The mentors will work with awardees throughout the project to focus on business, regulatory, clinical, and technical factors necessary for commercialization. Additional resources and support services may also be provided as appropriate.
Application Deadline
January 25, 2027