A proposal for MADE Scientific to operate the Mayo Clinic Discovery & Innovation GMP facility in Jacksonville — preserving on-campus manufacturing for Mayo investigators, and giving every program a governed path from first-in-human to commercial supply.
We won't have site manufacturing… when they hear about it, it's going to be concerning, because they know we were right there manufacturing the product, handing the product to them.Dr. Julie Allickson — Chief Technology Officer, Biotherapeutics, Mayo Clinic · 4 August 2026
That sentence is the whole problem, and it is a manufacturing problem before it is a commercial one. Mayo's investigators did not choose a CDMO — they chose Mayo. Their programs were built around a facility down the hall, a quality unit they know by name, and a release path they could walk. Replacing that with a vendor relationship is a real loss of adjacency, and every PI on the list will feel it.
Programs are mid-flight. Trials are accruing. A DC vaccine study has 25 of 78 patients enrolled; a licensed CAR T program has 4 of 18. Any transition that interrupts supply interrupts treatment.
The cartilage program needs its manufacturing partner named within roughly three months to satisfy RMAT expectations ahead of its FDA meetings. Several other programs are on similar regulatory cadences.
Even a well-run transfer to an off-site CDMO solves early phase and leaves the harder question open: who carries these products through pivotal and commercial, and on whose facility?
There is a version of this that isn't a loss. Mayo keeps manufacturing on the Jacksonville campus, keeps the adjacency its investigators depend on, and stops carrying the operating burden of a GMP facility that is not Mayo's core business. That is what this document proposes.
Not a hand-off to a vendor. A single operating spine where each stage has a named owner, and the transitions between them are designed rather than negotiated later.
The campus adjacency. The investigator relationship. The IRB, the tissue sourcing, the physician-sponsored trial machinery that no CDMO can replicate. Manufacturing stays in the building.
The operating burden. Staffing, quality systems, environmental monitoring, equipment lifecycle, audit readiness, and the fixed cost of a GMP facility running below capacity.
A defined graduation path. A program that succeeds in Jacksonville moves to Princeton for pivotal and commercial without re-tendering, re-transferring, or re-validating from zero.
Floor 2 is operational today. Floor 3 is 8,100 sq ft of new construction. Together they give six ISO 7 processing rooms with dedicated air handling, on-site QC, and cold chain — enough to run Mayo's current pipeline and take external work alongside it.
To be precise about the numbers below: 12,486 sq ft is the total D&I footprint across both floors. Of that, 3,579 sq ft is GMP manufacturing space (784 on floor 2, 2,795 on floor 3), with a further 3,752 sq ft of classified GMP support. The balance is QC, cold chain, offices and mechanical.
| Space | ISO | Sq Ft |
|---|---|---|
| GMP 1 · rm 224 | ISO 7 | 272 |
| GMP 2 · rm 225 | ISO 7 | 280 |
| GMP 3 · rm 226 | ISO 7 | 232 |
| GMP support — airlocks, gowning, MAL/PAL, corridors | ISO 7/8 | 1,077 |
| General — lab, freezer, storage, package inspection | — | 2,525 |
| Total | 4,386 | |
| Space | ISO | Sq Ft |
|---|---|---|
| cGMP 1 · rm 331 | ISO 7 | 510 |
| cGMP 2 · rm 332 | ISO 7 | 310 |
| cGMP 3 · rm 333 | ISO 7 | 310 |
| GMP released storage · rm 335 | ISO 7 | 380 |
| QC lab · rm 338 | — | 820 |
| Sterility lab, tissue & receiving, freezer, tanks | — | 985 |
| Corridors, airlocks, gowning, de-gowning | ISO 7/8/CNC | 1,215 |
| Total new construction | 8,100 | |
Source: CRB Facilities Overview — Florida, 18 June 2026. Room-level areas and ISO classifications as issued. MADE has completed a site walk of the 2nd floor.
Every figure below is drawn from Mayo's own facility overview and the 4 August 2026 discussion. Nothing here is a MADE estimate. It is the reason an operating partnership is viable on day one rather than year three.
Three GXP cell lines. Jun 2027 → Sep 2029. Program-level funding estimate for cell line work.
GMP master cell bank programme. Jun 2027 → Dec 2028.
Started Jan 2026. Process development complete Q1 2027, target completion Jul 2027.
| Program | Trial size | Accrued | Funding basis |
|---|---|---|---|
| DC vaccine program | 78 | 25 | ~$60K per run |
| Licensed CAR T program | 18 | 4 | ~$98K per patient |
| DC vaccine program (2) | 12 | 2 | $28K per product |
| Neo-antigen vaccine program | 36 | 12 | ~$12K per patient |
| Cryopreserved product program | 18 | 4 | ~$32K per patient |
| DC vaccine program (3) | 85 | 27 | ~$86K per patient |
| Six active studies | 247 | 74 | 173 patients still to treat |
programs across the enterprise are being prepared as CDMO RFPs — mostly Rochester investigators, with two anticipated from Florida. The Jacksonville facility is the natural landing site for the Florida programmes and a credible one for others.
MADE – Mayo discussion, 4 August 2026This is not a cold start. Four Mayo programmes are already live in MADE's commercial pipeline, two of them with proposals delivered.
| Programme | Stage | Proposal value | MADE lead |
|---|---|---|---|
| Hepatic-derived, kidney-targeted MSC | Proposal delivered | $1,898,500 | Simona Jusyte |
| XIAP HSC gene editing | Proposal delivered | $1,189,100 | Simona Jusyte |
| Phase III MSC master & working cell bank manufacturing | Engaged | — | Simona Jusyte |
| Extracellular vesicle manufacturing | Engaged | — | Simona Jusyte |
| Delivered to date | $3,087,600 | ||
REcycled CartiLage Auto/Allo IMplantation for the Treatment and Repair of Focal Knee Cartilage Defects. Phase I, 25 participants, Mayo Clinic sponsor. Primary completion May 2024.
Autologous chondrocytes in their pericellular matrix (chondrons) co-implanted with allogeneic adipose-derived MSCs in a fibrin glue carrier. Phase I, 15 participants, active. Primary completion December 2026.
The adipose-derived allogeneic MSC that RECLAIM depends on is precisely the bank that is running out of dating — and precisely the bank MADE is set up to re-establish, characterise and release.
Mayo pipeline figures as presented by Mayo Clinic in the CRB Facilities Overview. Trial totals are arithmetic sums of the stated per-study values, shown for convenience rather than as a revenue forecast. Programme and proposal values are MADE's own commercial records. Trial identifiers from ClinicalTrials.gov, retrieved 9 August 2026.
The partnerships below are announced and on the record. Each maps to a program Mayo described on 4 August.
MADE is in active tech transfer and PPQ for a recently approved commercial cell therapy, with an anticipated US FDA facility inspection as part of the post-approval supplement pathway no later than Q1 2027 — which would place MADE among a very small number of US CDMOs manufacturing an approved cell therapy. Client name withheld pending public disclosure.
60,000 sq ft, five Grade B cleanroom suites, FDA and EMA Annex 1 compliant. Around 120 staff running roughly 20 active customer programs.
These are not mutually exclusive endpoints — they are entry points. The structures below are ordered by how much balance sheet each party carries, and how quickly the arrangement can be stood up.
Mayo retains the asset and the lease. MADE operates the facility under a management agreement.
MADE assumes operation of the D&I GMP space and runs it as a MADE site. Mayo commits its pipeline as anchor demand at agreed rates; MADE fills residual capacity with external programs.
A shared operating entity with shared capital, shared economics, and shared upside on the 3rd-floor expansion.
Begin with Option 1 or a short Option 2 pilot scoped to a defined set of programs — the MSC master bank and one clinical program are the obvious candidates. Use that period to establish the quality interface, prove the release path, and build a real cost base. Convert to full anchor-tenant once the 3rd floor comes online, and revisit a joint venture only when both parties are operating from evidence rather than projection.
Commercial structures are presented for discussion. No pricing, fee level, or term is proposed in this document; those follow the RFP and a joint costing exercise.
Seventy-four patients are already accrued across six active studies. Continuity is the governing constraint on every decision below.
No active trial changes process, site, or release path during transition. Improvements come after continuity is proven, not during.
Each program keeps a named technical owner through the transition. PIs should notice better responsiveness, not a new vendor process.
Joint governance with Mayo quality and biotherapeutics leadership, with agreed escalation and audit rights from day one.
Joined September 2024 to rebuild and refocus the organisation on cell therapy. EY Entrepreneur of the Year 2026 finalist, New Jersey.
Fifteen years in the CDMO industry. Leading the Jacksonville due diligence and the Mayo relationship.
joseph.sinclair@madescientific.comFifteen years in CDMO cell therapy; doctorate in cell therapy manufacturing. Three and a half years at MADE.
Supporting the East Coast and European commercial territories.