DARPA SBIR DPA26BZ05-DV020: Universal Cell Culture Platform for Rapid Establishment of Species-Agnostic Cell Lines and Autonomous Culture Operations

Below is a brief summary. Please check the full solicitation before applying (link in resources section).

Quick Answer

DPA26BZ05-DV020 is a DARPA Direct to Phase II SBIR topic seeking a universal cell culture platform that can rapidly establish viable cell lines from non-model species and automate the culture optimization process that normally takes years. The award is worth up to 2,000,000 dollars over an 18 month period of performance, with no option period. Proposals are due September 23. This topic carries a lower CMMC Level 1 requirement and no ITAR restriction is listed.

What This Topic Is Looking For

Cell culture protocols today exist almost exclusively for well-characterized model organisms like human, mouse, and rat. For most other species, especially ones of interest for defense, biosecurity, agriculture, and public health, there is no established culture baseline, and building one from scratch normally takes years of manual, trial-and-error optimization that does not transfer well between labs. DARPA wants a platform that breaks this bottleneck, in part because it currently blocks gene-drive research in non-model invasive species.

Proposers must address two required components and are encouraged to address a third optional one.

Component 1 asks for species-agnostic biological methods, meaning universal or rapidly tunable media and substrate formulations, generalizable approaches to primary cell isolation, immortalization, or induced pluripotent stem cell reprogramming, and a structured, design-of-experiments framework for converging on viable culture conditions for a species that has never been cultured before.

Component 2 asks for autonomous, closed-loop culture automation, meaning independent environmental control per vessel or well so many optimization experiments can run in parallel, automated feeding, passaging, imaging, and sampling, and a closed-loop system where automated imaging and analysis feed directly into the next round of experimental conditions.

Component 3, which is optional but favorably reviewed, asks for the cellular substrate and workflows needed to characterize gene-drive and genetic biocontrol technologies in non-model species, strictly limited to in vitro and cellular work. No environmental release and no creation of a gene-drive-competent whole organism is permitted under this effort, and proposers addressing this component must explicitly address biosafety, biosecurity, and institutional oversight.

A proposer may only submit one proposal to this topic.

DP2 Feasibility and Phase II Structure

This is a Direct to Phase II topic, so no Phase I award will be made. Feasibility must already be demonstrated through prior work. For Component 1, that means showing established or maintained cell lines, or successful iPSC derivation, from at least two non-model species, ideally spanning more than one taxonomic class. For Component 2, that means showing prior operation of automated or closed-loop culture functionality with supporting performance data. For Component 3, if addressed, that means showing prior genome editing or construct delivery in a non-model cell line with documented biosafety practices.

Phase II is an 18 month effort aimed at advancing the platform from TRL 3 to 4 up to TRL 6 by program end. Performers stand up and validate the integrated platform against a reference species, then launch optimization campaigns on at least four new, non-model species not used in the feasibility demonstration, at least one of which must be vertebrate.

DARPA has set specific program metrics performers are expected to meet or exceed: less than 90 days to a validated cell line for a previously uncharacterized species, greater than 85 percent cross-run reproducibility with demonstrated cross-operator success, coverage of more than 4 species spanning more than 2 taxonomic classes, and genomic stability across more than 20 passages, equivalent to at least 5 generations. If Component 3 is addressed, performers also need to demonstrate in vitro construct delivery and gene-drive characterization with a functioning safeguard or containment mechanism.

Fixed milestones run from a Month 2 requirements analysis and biosafety baseline through a Month 17 capability demonstration across the required species set and a Month 18 final report.

Phase III Outlook

On the defense side, DARPA points to biosecurity and genetic biocontrol countermeasures, protecting force health from disease vectors, defending against invasive or pest species threatening installations and agriculture, and resilient, expeditionary biomanufacturing. Commercially, the platform applies to public health vector control, agricultural pest management, cellular agriculture and cultivated foods, biopharmaceutical and vaccine host line development, regenerative medicine, species conservation and biobanking, veterinary biotechnology, and contract research bioprocess development.

Funding and Timeline

Award amount: up to 2,000,000 dollars for the base period of performance.

Period of performance: 18 months, with no option period.

TABA: up to 25,000 dollars per Phase II project, reviewed at time of award.

Proposal deadline: September 23. Technical questions must be submitted by September 16, since DARPA does not answer questions submitted within 7 calendar days of the closing date.

Proposal Format

This topic uses the white paper and slide deck Technical Volume format. The white paper cannot exceed 20 pages and needs to cover goals and impact, Phase I equivalent feasibility, a technical plan with milestones no more than a month apart, management and capabilities including any biosafety and IBC oversight arrangements, and a transition and commercialization plan. The slide deck cannot exceed 15 slides and covers the same ground in pitch format, including cost, schedule, and DARPA's required quad chart templates.

All proposals go through DSIP and require the standard seven volumes: cover sheet, technical volume, cost volume, Company Commercialization Report, supporting documents, Fraud Waste and Abuse training, and the Disclosures of Foreign Affiliations webform, which must be completed as a webform and will not be accepted as a PDF upload.

Frequently Asked Questions

What is the deadline for DPA26BZ05-DV020? September 23. Technical questions must be submitted by September 16.

Is this a Phase I or Phase II award? Phase II only. No Phase I award will be made under this topic. Proposers must document feasibility equivalent to Phase I through prior work.

Are both required components mandatory? Yes. Component 1, species-agnostic culture methods, and Component 2, closed-loop automation, must both be addressed. Component 3, gene-drive enablement, is optional but favorably reviewed if included.

Does this topic allow whole-organism gene-drive work? No. Any Component 3 work is strictly limited to in vitro and cellular research. No environmental release and no creation of a gene-drive-competent whole organism is contemplated or permitted under this effort.

How many species does Phase II need to demonstrate? At least four new, non-model species not used in the original feasibility demonstration, with at least one of them vertebrate, and preference given to proposals covering a greater number of vertebrate or long-life-cycle species.

Can only one proposal be submitted per company? Yes. A proposer may submit only one proposal to this topic.

Is this topic export controlled? The topic sheet does not list ITAR or EAR restrictions the way several other Release 5 DARPA topics do, and it carries a lower CMMC Level 1 requirement, but companies should still confirm export control status for their specific technical approach before proposing.

Can venture capital or private equity backed companies apply? Yes. DARPA topics under this BAA explicitly accept proposals from companies more than 50 percent owned by venture capital operating companies, hedge funds, or private equity firms, provided the company registers with the SBA Company Registry Database and submits the required VC certification.

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DARPA SBIR DPA26BZ05-DV019: Semantically-Aware ISR