MADE has read eighteen Mayo cell therapy programs and written a technical evaluation of each one. This briefing is what we found, what we would recommend, and the ways a partnership could be structured — giving every program a governed path from first-in-human to commercial supply.
Founded 2016 out of the New Jersey Institute of Technology; majority-owned by GC Corporation since 2021. Headquarters at Princeton, New Jersey — 60,000 sq ft, five Grade B cleanroom suites, FDA and EMA Annex 1 compliant. Around 120 staff running over 20 active customer programs across CAR T, NK, iPSC-derived and MSC modalities.
On the floor and in the quality system — over 1,000 asset records in the Blue Mountain CMMS register, 400+ of them on a calibration or maintenance schedule. A Jacksonville fit-out starts from platforms MADE has already procured, validated and run. See the platform capability list, by unit operation and modality →
From MADE's Blue Mountain asset register and the February 2026 analytical instrument list. Asset counts are managed-equipment counts at Princeton, not capacity commitments.
Over 20 active client programs span CAR T and engineered T cell, allogeneic MSC, tissue and regenerative, iPSC-derived and platform work — plus a graduate bioprocessing curriculum built with NJIT to grow the workforce the sector is short of. The publicly announced partnerships appear in Track Record, each mapped to a need on Mayo's own list; the remainder are under confidentiality.
Conventional cell therapy process development takes 12+ months to reach clinical readiness. MADE's platform approach runs it in six, using pre-validated processes, equipment, documentation and pre-existing master banks — a reduction of up to 70% in development and scale-up time. Platforms exist for T cells, NK cells and MSCs.
Relevant to Mayo's clock: a partner must be named within roughly three months of 4 August to satisfy RMAT expectations. A six-month path to GMP readiness is the difference between meeting that and missing it.
A named practice with active MSC programs spanning early clinical development, GMP execution and commercial readiness — not an adjacent capability.
MADE's stated view of the risk profile — donor variability, sensitivity to handling, and scale-dependent shifts in cell behavior that surface late and cost time — is the same one behind Mayo's banks reaching end of dating.
Not a roadmap. These run today, and are what a MADE-operated Jacksonville would inherit on day one rather than build from scratch.
Qualified raw-material, single-use consumable and analytical supply chains; large-scale reverse-centrifugation harvest for allogeneic bioreactor processes; AI-driven robotic automation with Streamline Bio. The clinical and technology partnerships — MSC and EV supply, iPSC lines, vector and delivery platforms — are shown in Track Record, mapped against Mayo's needs.
MADE Scientific is majority-owned by GC Corporation of South Korea, a global leader in the pharmaceutical and biotechnology sectors. GC acquired the business in 2021 and is described in MADE's own filings as a long-term strategic shareholder providing stability, global perspective and sustained investment.
That matters for an operating partnership specifically. Standing behind a client's programs for years is a multi-year commitment with real capital behind it — staffing, quality systems, equipment lifecycle, and the build-out a growing program needs. MADE is not a venture-funded operator that needs the next round to honor year three of an agreement. GC has already funded a five-year business plan built on doubling down in cell therapy in the US market.
Six technology partnerships sitting behind the modalities in Mayo’s pipeline — starting material, vector, automation and process enhancement. Each is available to a Mayo program through MADE rather than through a separate negotiation.
MSC & extracellular vesicles
iPSC and iPSC derivatives
Vector and transduction
Automation and robotics
Process enhancement
Viral vector supply
The automation partnership is the one that bears directly on the Jacksonville operating question — a single day shift, three rooms that cannot run open concurrently, and a workforce we intend to keep. This is the platform in a live manufacturing setting.
39 photographs of the operating facility — campus, GMP suites, QC and analytical laboratories, development and MSC labs. Select a category, then any image to open it full screen.
MADE Scientific, 201 College Road East, Princeton, New Jersey. Photographed 2025–2026.
The partnerships below are announced and on the record. Each maps to a program Mayo described on 4 August.
One-stage cartilage repair — chondrons mixed with allogeneic MSCs, single surgical procedure Commercial-grade allogeneic MSC master bank, adipose-derived MSC-derived extracellular vesicles from placental chorionic-plate cells Engineered, differentiated iPSC program — three GXP cell lines CAR T process development and a licensed CAR T program in trial Allogeneic Phase I/II supply and first-in-human programsMADE is building its clinical-to-commercial network deliberately, one site at a time, so capacity is added while existing client programs remain undisrupted — a further regional manufacturing facility, and a second Princeton building of roughly another 60,000 sq ft, as set out to the Mayo team on 4 August. Jacksonville is the next step in that plan, and the first where the capacity arrives with a clinical partner already attached.
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.
Mayo's own biomanufacturing model is explicit: accelerate discoveries into early stage clinical trials, then work with industry to bring them to patients. The Center for Regenerative Biotherapeutics describes 50,000 square feet and fifteen ISO-classified cleanrooms across three campuses, qualified for phase 1 and phase 2. That is a deliberate design, and it works. It also means the handoff is a planned part of the model rather than an afterthought — and the handoff is what MADE does.
Before being asked to quote, MADE assessed eighteen Mayo cell therapy programs and wrote a technical evaluation of each — process, analytics, comparability, regulatory position. Every one is in the Programs tab. Nothing in them is priced.
Programs are mid-flight and trials are accruing. Any transfer has to be designed backwards from a dosing schedule, a radiotherapy calendar or an operating room date — not from a manufacturing slot. Several of the assessments say exactly where that bites.
The cartilage program needs a manufacturing partner named within roughly three months to satisfy RMAT documentation ahead of its FDA meetings. Other programs sit on their own regulatory cadences. Those dates are the reason to talk now rather than later.
What MADE is proposing is not a vendor relationship. It is a partner that takes the programs Mayo has built through pivotal and commercial manufacture, on a defined path, without asking any investigator to change what they have already shown works.
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 — sized for Mayo's current pipeline with room for 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 GMP support space. 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 |
| Corridors, airlocks, gowning, de-gowning, closet | ISO 7/8/CNC | 1,285 |
| Sterility lab, tissue & receiving, freezer, tanks | — | 985 |
| Lab storage & product release | — | 870 |
| cGMP workspaces & mechanical | — | 2,080 |
| Process development space | — | 550 |
| 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 input below is Mayo's own — the facility overview of 18 June and the 4 August discussion. The arithmetic on top of it is ours, and it is shown in full at the foot of this section. 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 program. Jun 2027 → Dec 2028.
Started Jan 2026. Process development complete Q1 2027, target completion Jul 2027.
| Program | Trial size | Accrued | To treat | Funding basis | Value remaining |
|---|---|---|---|---|---|
| DC vaccine program | 78 | 25 | 53 | ~$60K per run | $3.18M |
| Licensed CAR T program | 18 | 4 | 14 | ~$98K per patient | $1.37M |
| DC vaccine program (2) | 12 | 2 | 10 | $28K per product | $0.28M |
| Neo-antigen vaccine program | 36 | 12 | 24 | ~$12K per patient | $0.29M |
| Cryopreserved product program | 18 | 4 | 14 | ~$32K per patient | $0.45M |
| DC vaccine program (3) | 85 | 27 | 58 | ~$86K per patient | $4.99M |
| Six active studies | 247 | 74 | 173 | still to treat | $10.56M |
Scroll the table sideways for the remaining columns.
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 programs and a credible one for others.
MADE – Mayo discussion, 4 August 2026The 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, characterize and release.
This is not a cold start. Four Mayo programs are already live in MADE's commercial pipeline, two of them with proposals delivered.
| Program | Mayo investigator | Stage | Proposal value | MADE lead |
|---|---|---|---|---|
| Hepatic-derived, kidney-targeted MSC | Dr. Timucin Taner · Transplant Surgery, Rochester | 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 | Dr. Daniel B. F. Saris · RECLAIM (likely) | Engaged | — | Simona Jusyte |
| Extracellular vesicle manufacturing | — | Engaged | — | Simona Jusyte |
| Delivered to date | $3,087,600 | |||
Scroll the table sideways for the remaining columns.
Mayo investigator attributions are MADE's read of its own engagement records and the public registry, offered for correction.
Total identified pipeline including work already delivered: $22.78M. Cumulative across each program's stated timeline — the preclinical programs run to 2028–29 — not an annual figure.
How this is calculated. Every input is Mayo's own, from the CRB Facilities Overview of 18 June 2026; value remaining is (trial size − accrued) × the stated funding basis. Three caveats, stated plainly: the DC vaccine lines are quoted per run and per product, treated here as one-to-one with patients; funding bases indicate scale, not CDMO pricing; and the $7.68M is funding currently available, with remaining need sought through grants or development funding. This excludes entirely the roughly nine programs being prepared as CDMO RFPs across the enterprise. Trial identifiers from ClinicalTrials.gov, retrieved 9 August 2026.
Mayo's cell-therapy work is public science with names on it. These are the investigators MADE has read, what each one is building, and where a manufacturing partner would matter to them. Drawn from ClinicalTrials.gov and Mayo's own public pages. The portfolio tables follow in the next two sections.
It is absolutely essential to our research to have biomanufacturing facilities on-site, near the patient…Keith L. Knutson, PhD — Professor of Immunology, Mayo Clinic in Florida · Center for Regenerative Biotherapeutics, mayo.edu
Director, Blood & Marrow Transplant and Cellular Therapy, Mayo Clinic in Florida
BAFF-R CAR T (MC10029) for relapsed/refractory B-cell malignancies, including patients who have failed CD19 CAR T. Developed at Mayo Florida; Jacksonville is the sole trial site. Every dose is a per-patient autologous GMP manufacture.
Scientific developer, FRαDC vaccine — Professor of Immunology; Leader, Grohne Cancer Immunology & Immunotherapeutics Research Program
FRαDC dendritic-cell vaccine (FAROUT) — maintenance immunotherapy for stage III/IV ovarian cancer, 78-patient target, recruiting at all three Mayo campuses including Jacksonville. PI of record Matthew S. Block, MD, PhD; Jacksonville site investigator Gerardo Colon-Otero, MD. A companion Phase 1/2 with pembrolizumab (FRAPPE, NCT05920798) runs alongside.
Consultant, Neurologic Surgery, Mayo Clinic in Florida (Chair, 2016–2024)
Allogeneic adipose-derived MSCs delivered into the resection cavity for recurrent glioblastoma — a Jacksonville-only trial built on allogeneic MSC banks.
Bacardi Associate Director, Center for Regenerative Biotherapeutics in Florida
CELLKINE — allogeneic bone-marrow MSCs for lumbar facet arthropathy, run at Jacksonville. Also PI of record on CELLTOP II (NCT04520373), intrathecal MSC therapy for spinal cord injury.
Chair, Division of Vascular Surgery, Mayo Clinic in Florida
Allogeneic adipose MSCs applied at fistula creation to improve dialysis-access maturation for patients in kidney failure — sponsor-investigator, Jacksonville.
Professor of Orthopedic Surgery and Regenerative Medicine; Co-Chair, Sports Medicine
One-stage cartilage restoration — autologous chondrons with allogeneic adipose-derived MSCs. Knee Phase 1 complete (NCT03672825, 25 patients); Hip RECLAIM active (NCT05553132, trial PI Aaron J. Krych, MD). The program depends on the allogeneic MSC bank this proposal re-establishes.
Neurology, Mayo Clinic
Intrathecal autologous adipose MSCs for multiple system atrophy — randomized, placebo-controlled, 71 patients enrolled.
Hematology, Mayo Clinic
CD19 CAR T (IC19/1563), manufactured in-house at Mayo under a point-of-care model — the enterprise's own proof that on-campus manufacturing matters.
Mayo's own development-stage snapshot, read across the manufacturing question: what each program is, who is named on it in the public record, and where a manufacturing partner would fit.
Mayo's own development-stage snapshot of 6 August, read across the manufacturing question: what each program is, who is named on it in the public record, what it needs made, and where it sits against enrollment. The counts and funding notes are Mayo's own and carry Mayo's caveat that they be validated before external use — the manufacturing column is MADE's read, offered for correction.
| Program | Stage | Named in the public record | What it is | What it needs made | Enrollment |
|---|---|---|---|---|---|
| Phase 2 · active enrollment | |||||
| FRαDC (ENT) | Phase 2 | Matthew S. Block, MD, PhD (PI of record) · Keith L. Knutson, PhD (developer) · Gerardo Colon-Otero, MD (Jacksonville) | Folate-receptor DC vaccine vs placebo, advanced epithelial ovarian cancer; apheresis stability study | Autologous monocyte-derived DC per run — apheresis, differentiation, antigen loading, cryopreserved doses | 17 / 61 44 to treat ~$38K per run |
| DC liver cancer | Phase 2 | — | Cholangiocarcinoma and hepatocellular carcinoma; apheresis stability study | Autologous DC on the same platform as FRαDC — shared process and release panel | 27 / 58 27 to treat ~$37K per patient |
| IND · Phase 1 | |||||
| BAFF-R CAR T (JAX) | Phase 1 | Mohamed A. Kharfan-Dabaja, MD, MBA — NCT06191887 | B-cell malignancies, dose escalation. Jacksonville is the sole site | Autologous CAR T per patient — selection, activation, transduction, expansion, plus vector supply | 18 planned ~14 to treat ~$98K per patient |
| TX-103 | Phase 1 | Wendy J. Sherman, MD (Jacksonville site) · sponsor Tcelltech — NCT06482905 | Anti-B7-H3 CAR T, intraventricular delivery, grade 4 glioma. Moving to Florida | Sponsor-supplied product; Mayo-side handling, dose preparation and administration support | 4 / 13 ~$21K per process |
| Neoantigen (PHX) | Phase 1 | — | Solid-tumor dendritic-cell vaccine with personalized neoantigen loading | Autologous DC with per-patient antigen preparation — the most bespoke of the DC set | 12 / 36 24 left to treat ~$12K per process |
| IND-enabling · manufacturing readiness | |||||
| TSHR CAR T | IND-enabling | — | TSH-receptor CAR T; goal to submit IND by October | Process lock, engineering runs and IND CMC on the tightest clock on the board | Projected 20 |
| Neonatal EV (Skoll) | IND-enabling | — | Extracellular vesicles; Skoll-funded ~$3.4M; IND targeted by October | EV drug substance and product from a qualified bank — bioreactor expansion, TFF, fill, stability | Projected 20 |
| Neonatal bank | Qualified | — | MCB/WCB storage supporting EV production | Cell banking, characterization and release — straightforward scope, and the enabler for the EV program above | — |
| Process and analytical development | |||||
| Dual CAR / oncolytic virus | PAD | — | Expected to finish PAD in Q4 2026, then IND / Phase 1 | Combination cell and viral product — two manufacturing trains and a combined release strategy | ~$500K to Phase 1 |
| Pleural sealant | PAD | — | PD engineering run in Arizona by December; tech transfer to a GMP CDMO already planned | The most immediately actionable program here — Mayo has already named a CDMO transfer as the next step | — |
| Platform · early planning | |||||
| LiVE platform (PRINT) | Early planning | Julie G. Allickson, PhD — Mayo lead PI, ARPA-H award | Bioprinted liver; starts in approximately one year | cGMP iPSC-derived hepatocytes, hepatic stellate and endothelial cells including hypoimmune lines, at scale | ~$2.7M |
| EASE platform | Early planning | — | Needs an FDA INTERACT meeting | Pre-IND CMC strategy and a manufacturing plan to take into INTERACT | ~$4.5M |
| Liver progenitor cells (HepaTX) | Early planning | — | STTR submitted; earmarked for process and analytical development | PAD scope — process definition and analytical method development | — |
Stages, counts and funding notes from Mayo's CRB selected product portfolio snapshot of 6 August 2026. Investigator attributions come from ClinicalTrials.gov and Mayo public pages only — a dash means no public record was found, not that none exists. The manufacturing column is MADE's assessment.
Beyond Mayo's own trials, a wider portfolio Mayo originated, co-founded or licensed out is advancing in partner and spin-out hands. It is the clearest evidence of what the discovery engine produces — and of what a manufacturing partner would be asked to carry.
Beyond the trials above, GlobalData ties a wider cell & gene therapy portfolio to Mayo Clinic — programs Mayo originated, co-founded or licensed out, now advancing in partner and spin-out hands. The science starts on campus; this is where it goes.
| Program | Modality | Lead indication | Stage | Developer | Mayo role | FDA designations |
|---|---|---|---|---|---|---|
| AVB-114 | Cell therapy | Anal Fistula | Phase II | Avobis Bio | Originator · JV with W L Gore & Associates (UK) | RMAT · FT |
| Cellular Immunotherapy 1 for Oncology | Cell therapy | Metastatic Melanoma +4 more | Phase II | Mayo Clinic | Developer | — |
| Cellular Immunotherapy for Hepatocellular Carcinoma and Bile Duct Cancer | Cell therapy | Bile Duct Cancer (Cholangiocarcinoma) +1 more | Phase II | Mayo Clinic | Developer | — |
| MB-106 | Gene-modified cell | Follicular Lymphoma +13 more | Phase II | Mustang Bio | License ended | RMAT · ODD |
| Autologous DC Vaccine | Cell therapy | Recurrent Respiratory Papillomatosis (Juvenile Laryngeal Papilloma or Laryngeal Papilloma) | Phase I | Mayo Clinic | Developer | — |
| IC-19/1563 | Gene-modified cell | B-Cell Non-Hodgkin Lymphoma +2 more | Phase I | Mayo Clinic | Developer | — |
| MB-105 | Gene-modified cell | Metastatic Castration-Resistant Prostate Cancer (mCRPC) +3 more | Phase I | City of Hope | License ended | — |
| MB_101 | Gene-modified cell | Anaplastic Astrocytoma +5 more | Phase I | Mustang Bio | License ended | ODD |
| MC-10029 | Gene-modified cell | B-Cell Chronic Lymphocytic Leukemia +3 more | Phase I | Mayo Clinic | Developer | — |
| Mesenchymal Stem Cells | Cell therapy | End-Stage Kidney Disease (End-Stage Renal Disease or ESRD) | Phase I | Mayo Clinic | Developer | — |
| MUC1-Activated T-Cells | Cell therapy | Epithelial Ovarian Cancer +4 more | Phase I | Mayo Clinic | Developer | — |
| Cellular Immunotherapy for Oncology | Cell therapy | Astrocytoma +3 more | Phase 0 | Mayo Clinic | Developer | — |
| AMPA-CAR-MSC | Gene-modified cell | Alzheimer's Disease | Preclinical | Mesoblast | Technology licensed to Mesoblast | — |
| CAR-MSC-CCN1 | Gene-modified cell | Wounds | Preclinical | Mesoblast | Technology licensed to Mesoblast | — |
| CD19-CAR-MSC | Gene-modified cell | Lupus Nephritis | Preclinical | Mesoblast | Technology licensed to Mesoblast | — |
| Cell Therapy Program | Cell therapy | Liver Diseases | Preclinical | Cytotheryx | Technology licensed to Cytotheryx | — |
| COL2A1-CAR-MSC | Gene-modified cell | Rheumatoid Arthritis | Preclinical | Mesoblast | Technology licensed to Mesoblast | — |
| ECAD-CAR-MSC | Gene-modified cell | Crohn's Disease (Regional Enteritis) +1 more | Preclinical | Mesoblast | Technology licensed to Mesoblast | — |
| MC-9999 | Gene-modified cell | Glioblastoma Multiforme (GBM) | Preclinical | Mayo Clinic | Developer | — |
| MOG-CAR-MSC | Gene-modified cell | Multiple Sclerosis | Preclinical | Mesoblast | Technology licensed to Mesoblast | — |
| SC-451 | Cell therapy | Type 1 Diabetes (Juvenile Diabetes) | Preclinical | Sana Biotechnology | Affiliated† | — |
| CCB-001 | Gene-modified cell | Osteogenesis Imperfecta | Discovery | Castle Creek Biosciences | Affiliated† | — |
| CCB-003 | Gene-modified cell | Ehlers-Danlos Syndrome Hypermobility Type (Type III) | Discovery | Castle Creek Biosciences | Affiliated† | — |
| CCB-005 | Gene-modified cell | Ehlers-Danlos Syndrome (Cutis Hyperelastica) | Discovery | Castle Creek Biosciences | Affiliated† | — |
| Pancreatic Beta Cell Therapy | Cell therapy | Type 1 Diabetes (Juvenile Diabetes) | Discovery | Syntax Bio | Affiliated† | — |
| Allogeneic Tumor Cells + Cellular Immunotherapy for Prostate Cancer | Cell therapy | Prostate Cancer | Inactive | Mayo Clinic | Developer | — |
| ATIP | Cell therapy | Congestive Heart Failure (Heart Failure) | Inactive | Celyad Oncology SA | Technology licensed to Celyad SA | — |
| C-Cure | Cell therapy | Congestive Heart Failure (Heart Failure) | Inactive | Celyad Oncology SA | Originator · licensed to Celyad SA | FT |
| C-Cure2 | Cell therapy | Congestive Heart Failure (Heart Failure) | Inactive | Celyad Oncology SA | Technology licensed to Celyad SA | — |
| C3BSAQR-1 | Cell therapy | Myocardial Infarction | Inactive | Celyad Oncology SA | Technology licensed to Celyad SA | — |
| C3BSCQR-2 | Cell therapy | Congestive Heart Failure (Heart Failure) | Inactive | Celyad Oncology SA | Technology licensed to Celyad SA | — |
| FAH | Gene-modified cell | Tyrosinemia | Inactive | Castle Creek Biosciences | Originator | ODD |
| Gene Therapy to Target EMR1 for Eosinophilic Leukemia | Gene-modified cell | Leukemia | Inactive | Humanigen | Technology licensed to Humanigen | — |
| Gene Therapy to Target EPHA3 for Blood Cancer and Solid Tumor | Gene-modified cell | Blood Cancer +1 more | Inactive | Humanigen | Technology licensed to Humanigen | — |
| MB-102 | Gene-modified cell | Blastic Plasmacytoid Dendritic Cell Neoplasm (BPDCN) +3 more | Discontinued | Mustang Bio | License ended | ODD |
| MB-103 | Gene-modified cell | Brain Cancer +2 more | Discontinued | Mustang Bio | License ended | — |
| MB-104 | Gene-modified cell | Multiple Myeloma (Kahler Disease) | Discontinued | Mustang Bio | License ended | — |
Source: GlobalData Pharma Intelligence, drug and investigator exports extracted 11 August 2026 · 37 unique programs with Mayo Clinic as parent, originator or partner · stages, designations and partnering as recorded by GlobalData, offered for correction. † Mayo Clinic parent-company tag per GlobalData; no agreement row in the export.
Trial identifiers, phases, statuses and investigators as listed on ClinicalTrials.gov, retrieved 9 August 2026; titles from Mayo Clinic public pages. The Center for Regenerative Biotherapeutics — W. A. Faubion Jr., MD, Executive Medical Director; Julie G. Allickson, PhD, Chief Technology Officer; Abba C. Zubair, MD, PhD, Medical Director, Transfusion Medicine and Stem Cell Therapy in Florida, two decades leading the campus stem-cell laboratory. Any pairing of registry entries with the programs in Mayo's own overview is MADE's read of the public record, offered for correction.
The section above is Mayo’s public science. This one is the working record: what has reached MADE, what stage it is at, and what we have written about it. It is reconciled from Salesforce, PandaDoc, the RFPs Mayo has sent, and the meetings of 4 and 12 August — and it is deliberately honest about how little has yet been formally proposed.
MADE has written a technical evaluation and CDMO frame for every actively discussed program, and a longer technical deep dive behind each one. The deep dives are built on six modality cores — autologous CAR-T, MSC, dendritic cell, extracellular vesicles, gene-modified HSC, and encapsulated allogeneic cell therapy — so a reader moving between two programs on the same modality sees the same chapter numbers mean the same things.
| Investigator | Program | Modality | RFP | Status with MADE |
|---|---|---|---|---|
| Rochester | ||||
| Alexander Revzin, PhD | TT + GMP of HEK-293 based Biologics Factory 806 | Encapsulated allogeneic | — | New |
| Daniel B. F. Saris, MD, PhD | Phase III MSC MCB & WCB manufacturing 23555-2026 | MSC | — | Engaged |
| Jian L. Campian, MD, PhD | Neuro-oncology cell therapy — recurrent glioblastoma | Autologous CAR-T | — | No opportunity opened |
| Julie K. Heimbach, MD and Robert C. Huebert, MD | Autologous Adipose-MSC 23735-2026 | MSC | Received 08.18.26 | Technical Appraisal |
| Laura J. Lambert, PhD | XIAP HSC Gene Editing 23155-2026 | Gene-modified HSC | Received 20JUL2026 | Proposal delivered 2026-07-29 · PandaDoc viewed |
| Lewis R. Roberts, MB, ChB, PhD | TT + GMP Autologous DC for Liver Cancer 23745-2026 | Dendritic cell | Received 18Aug26 | New |
| Matthew S. Block, MD, PhD | FRαDC dendritic-cell vaccine (FAROUT) — NCT06639074 | Dendritic cell | — | No opportunity opened |
| Richard G. Vile, PhD | Program not yet defined with MADE | Not yet established | — | No opportunity opened |
| Saad J. Kenderian, MB, ChB | TT Comparability and GMP Manufacture of TSHR CAR-T 23725-2026 | Autologous CAR-T | — | Technical Appraisal |
| Saranya Wyles, MD, PhD | Allogeneic MSC-derived extracellular vesicle (EV) 23785-2026 | Extracellular vesicles | Received 08.04.26 | Engaged |
| Timucin Taner, MD, PhD | Mayo Clinic-Hepatic-derived, Kidney Targeted MSC Program 22345-2026 | MSC | Received | Proposal delivered 2026-03-26 · PandaDoc voided |
| Wenchun Qu, MD, PhD | Autologous adipose MSC — spinal cord injury | MSC | — | Phase 2 recruitment and injection complete |
| Jacksonville | ||||
| Hong Qin, MD | BAFF-R CAR-T (MC10029) — relapsed/refractory B-cell malignancies | Autologous CAR-T | — | Phase 1/2 |
| Keith L. Knutson, PhD | Cancer vaccine portfolio — dendritic cell, DNA, RNA, peptide, nanoparticle | Dendritic cell | — | Roughly 7 clinical trials running |
| Mohamed A. Kharfan-Dabaja, MD, MBA | BAFF-R CAR-T (MC10029) — NCT06191887 | Autologous CAR-T | — | No opportunity opened |
| Wenchun Qu, MD, PhD | CELLKINE — allogeneic bone-marrow MSC, lumbar facet arthropathy | MSC | — | Phase 2 active |
| Wenchun Qu, MD, PhD | mRNA-engineered MSC-EV — IL-1RA-EV and GH1-EV, intradiscal | Extracellular vesicles | — | Pre-IND |
| Yanyan Lou, MD, PhD | Thoracic and medical oncology — allogeneic cell therapy | Not yet established | — | No opportunity opened |
Reconciled 2026-08-24 across Salesforce, the MADE reporting mirror, PandaDoc, the Mayo client folder, and the record of meetings held on 4 and 12 August 2026. Stage and value come from Salesforce; proposal status comes from PandaDoc. Of the 2 proposals MADE has delivered to Mayo, 1 is now voided and its fees have expired — every other program below is pre-proposal. Programs shown without an opportunity are ones MADE is tracking, not ones Mayo has asked us to quote.
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.
Jacksonville is the first choice for a Mayo program — it keeps the work on campus and next to the investigator. But routing follows the science: where program fit, equipment or specific expertise point elsewhere, Princeton can take a program from the start, and a second US site is coming online for scale-up. Either way both paths converge on the MADE network for Phase II/III and commercial supply.
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 facility whose utilization Mayo does not control.
A defined graduation path. Wherever a program starts, it moves onto the MADE network for pivotal and commercial without re-tendering, re-transferring, or re-validating from zero.
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.
Option 2 is the destination. It is the only structure where Mayo's fixed cost becomes variable, MADE's utilization is solved by Mayo's own pipeline, the 3rd-floor build-out gains a business case — and investigators keep the campus adjacency they care about.
Start where Mayo prefers: a management agreement, 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. Either establishes the quality interface, proves the release path, and builds 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.
Jacksonville keeps the program on campus and next to the investigator. When a program outgrows it — scale, schedule, or a modality better matched elsewhere — these are the sites it graduates onto, without re-tendering or re-validating from zero.
Princeton, New Jersey
MADE’s active GMP campus and the site every Mayo program can reach today. Five Grade B cleanrooms, each with its own air handling unit, running autologous and allogeneic cell therapy across MSC, EV, iPSC, CAR-T, NK and TIL.
Greater Philadelphia, Pennsylvania
The nearer-term expansion, commissioning through the back half of 2026. Fitted cleanroom suites and QC laboratory space that take pressure off Princeton as Mayo programs ramp, and give the network a second qualified US location.
Princeton, New Jersey
The commercial-scale building on the Princeton campus, a clear-span shell being fitted out as seven manufacturing suites on a Grade B core with Grade C supply and Grade D return corridors. This is where a Mayo program goes for pivotal and commercial supply.
Ten investigator and leadership sessions between 9:30 and 17:00 in Siebens 4-05A. Each row opens the technical evaluation MADE has already written for that program. Where a session has no evaluation yet, it says so rather than leave a gap.
| Time | Session | Mayo presenters | Package |
|---|---|---|---|
| 9:30 | Welcome & IntroductionsBreakfast, coffee and beverages available | Julie Allickson, PhD | |
| 10:00 | Project Overview & CollaborationBoth joining remotely | Julie K. Heimbach, MD · Robert C. Huebert, MD | Autologous Adipose-MSC |
| 10:30 | Research Executive Leadership TeamExecutive Dean of Research; Chair and Associate Administrator, Research Administration | Vijay Shah, MD · Heidi Dieter · Jolene Summer Bolster | |
| 11:05 | MADE Scientific Overview & CollaborationClinical Genomics — joining remotely | David Deyle, MD | Gene-corrected cells for osteogenesis imperfecta |
| 11:30 | Project Overview & Collaboration | Saranya P. Wyles, MD, PhD | Allogeneic MSC-derived extracellular vesicle (EV) |
| 12:00 | LunchSiebens 4 Café open 11:00–13:00 | ||
| 12:30 | Project Overview & CollaborationDr. Knutson and Dr. Gustafson joining remotely | Matthew S. Block, MD, PhD · Keith L. Knutson, PhD · Michael P. Gustafson, PhD | FRαDC dendritic-cell vaccine (FAROUT) — NCT06639074Cancer vaccine portfolio — dendritic cell, DNA, RNA, |
| 13:00 | MADE Scientific Overview & CollaborationMedical Director, Regenerative Biotherapeutics (RST) | Wen Lu, MD | assessment in preparation |
| 13:30 | MADE Scientific Overview & CollaborationDivision Chair, Hematology (RST) | Stephen M. Ansell, MD, PhD | assessment in preparation |
| 14:00 | Open time | ||
| 14:30 | Open time | ||
| 15:00 | Project Overview & CollaborationDr. Revzin joining remotely | Alexander Revzin, PhD · Michael Slama, MS | TT + GMP of HEK-293 based Biologics Factory |
| 15:30 | Project Overview & Collaboration | Daniel Saris, MD, PhD | Phase III MSC MCB & WCB manufacturing |
| 16:00 | Project Overview & CollaborationDr. Park joining remotely | Yi Lin, MD, PhD · Jonas Paludo, MD · Lewis Roberts, MB, ChB, PhD · Sean S. Park, MD, PhD | TT + GMP Autologous DC for Liver Cancer |
| 16:45 | Wrap-up & Next Steps | Julie Allickson, PhD | |
| 17:00 | Adjourn |
Running order, presenters and attendance, sent on 1 September.
The full index by site and investigator, each opening its technical evaluation and deep dive.
Eighteen programs mapped, fourteen with a technical evaluation and sixteen with a deep dive. Five of Thursday's sessions are with colleagues whose own work we have not scoped — research leadership, and Dr. Lu and Dr. Ansell.
74 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.
The MADE leadership team. An operating partnership is not a sales relationship — quality, technical operations, people and finance all carry a piece of it from day one.
In Jacksonville on 11–12 August: Syed Husain, David Smith, Kenneth Warrington and Joe Sinclair. Irving Ford (Quality) and Jill Gliem (Technical Operations) join the quality and operations sessions on request — they would carry the D&I quality system and the suites respectively.
Joined September 2024 to refocus MADE on cell therapy. EY Entrepreneur of the Year 2026 finalist, NJ.
Leads the Jacksonville due diligence and the Mayo relationship. Fifteen years scaling CDMO operations.
Leads MS&T, process and analytical development. Would own the MSC master bank and every transferred process.
Would assume the D&I quality system and own inspection readiness. Led quality for the TECELRA® BLA; supported ABECMA®, BREYANZI® and KYMRIAH®.
Would take day-to-day responsibility for the Jacksonville suites. Twenty years in biopharmaceutical manufacturing.
Would own the transition plan and the named per-program owner each Mayo investigator keeps.
Transferring the existing Mayo team is an HR question first. Has run M&A people integration from diligence to close.
Would stand up whichever commercial structure Mayo chooses, and own the cost base after transfer.
On the Mayo account since the first session. Simona leads all proposal programs — the RFP response runs through her.
Would cover Mayo's Arizona campus alongside Florida. Internal depth on the iPSC market.
Announced August 2025. The board shapes MADE's scientific and technology roadmap, with a standing brief to lower cost of goods for cell therapy manufacture.
Former CEO of Bone Therapeutics and Zelluna Immunotherapy; CMO/COO at TxCell. Served at the European Medicines Agency and holds leadership roles with the Alliance for Regenerative Medicine.
Board member at Vericel and Cynata Therapeutics. Previously CEO of Obsidian Therapeutics, Sigilon (acquired by Eli Lilly), Ocata Therapeutics (acquired by Astellas) and Antares Pharma.
Former Head of Technical Operations at Cargo Therapeutics and Global Head of Cell Therapy MS&T at Juno Therapeutics, where he helped launch two commercial CAR T therapies. Earlier at Genentech and Roche.
Site principal investigator for adoptive cellular therapy trials in melanoma, head and neck, and non-small cell lung cancer — a practicing physician-investigator, which is the model Mayo runs.
Strengthened in 2026 to support scale-up and commercial readiness, with GC Corporation represented on the board.
Forty years in CDMO operations across drug substance, drug product and analytical testing. Most recently Chief Operating Officer of BioVectra.
Twenty-three years of strategic advisory in bio-healthcare, from multinationals to emerging enterprises.
Twenty-five years across life sciences, healthcare delivery and digital health, bridging commercial strategy with emerging platforms.
Global investment management and corporate finance; previously Director of Finance and Accounting at GCAM.
