Syed T. Husain
Chairman & Chief Executive Officer
Previously
Start here
The program on one page
Where STM-01 stands, what Made Scientific proposes, and how the move is de-risked. Each panel links to the detail.
Where STM-01 is
Phase 2 in DMD cardiomyopathy
THRIVE-2 opened on 29 September 2026. Phase 3 will need 6 to 10 batches from a locked 50 L process with a potency assay on the CoA.
What we propose
11 work orders in 3 milestones
Technology transfer and process confirmation, GMP readiness, then GMP manufacture at East Norriton. Proposal 23645-2026, issued 2 October 2026.
Proof first
Two full 50 L runs on STM-01 cells
Milestone 1 ends with a feasibility run and a confirmation run at full working volume, the second filled on the ARES X20+. The rest of the program commits once Secretome has seen them.
Capital
No equipment purchase for Secretome
Made Scientific buys, installs and qualifies two Xiogenix ARES X20+ fillers and the wash and concentration platform at its own expense.
Where
East Norriton, Pennsylvania
An STM-01 suite with seed and culture around the Sartorius BIOSTAT STR 50 L, a Grade B fill and finish room, controlled-rate freezing and staging.
When
About eight months to GMP manufacture
The representative timeline in the proposal, in months from program start. Calendar dates are set at contract execution; durations start when client-supplied materials and approvals are in.
STM-01 today
Where the program stands
What the public record and Secretome's answers to our questionnaire tell us about STM-01, and what Phase 3 asks of the manufacturing site.
Phase 2THRIVE-2 in DMD cardiomyopathy, opened 29 September 2026
50 Lstirred-tank microcarrier process developed with RoosterBio
6–10Phase 3 batches Secretome anticipates
INDactive, amended in 2025 to describe this process
STM-01 in brief
- Allogeneic neonatal cardiac progenitor cells, given by intravenous infusion. The effect is attributed to what the cells secrete, with anti-inflammatory and anti-fibrotic activity.
- Duchenne muscular dystrophy cardiomyopathy: THRIVE-2, a multicenter, multi-dose, open-label Phase 2, opened on 29 September 2026.
- Heart failure with preserved ejection fraction: Phase 1 data presented at HFSA on 11 October 2026, with FDA Fast Track designation since March 2025.
- Dilated cardiomyopathy: an investigator-sponsored Phase 1 at Emory University.
Manufacturing so far
- RoosterBio took the process from 2D flasks to a 50 L stirred-tank microcarrier process and completed a full-scale run in 2025.
- Cellipont, part of Kincellis since September 2026, manufactured the master cell bank and is making Phase 2 material.
- The seed train runs 7 days in T-225 flasks and HYPERflasks, expansion 5 days in the Sartorius BIOSTAT STR 50 L, then a 1-day harvest and fill into OriGen CS250 bags.
- The process is not yet locked. Secretome plans to lock it before Phase 3, and the potency assay is in development.
What Phase 3 asks of the manufacturing site
- A locked process, with the potency assay transferred and on the certificate of analysis.
- Comparability between Phase 2 and Phase 3 material, planned before the first GMP lot rather than after it.
- Capacity for 6 to 10 batches, and automated fill and finish at full batch scale.
- Stability data that supports the shelf life, and a site that can carry the program into commercial supply.
Transfer plan
How we de-risk bringing STM-01 to East Norriton
Whether East Norriton becomes a second Phase 3 site or the primary one, the transfer has to be proven before it is relied on. The plan is built so Secretome sees evidence before it commits, Phase 2 supply continues undisturbed, and Phase 3 material is comparable by design.
Evidence first
Proof before commitment
Two full-scale 50 L runs on STM-01 cells in Milestone 1, the confirmation run filled on the ARES X20+ and reported for Secretome's approval. The proposed commitment structure follows.
Capital
No equipment purchase for Secretome
Made Scientific buys, installs and qualifies the two ARES X20+ fillers and the Unifuge Pilot. The fillers carry a vendor-confirmed lead time of about 12 weeks and are ordered at contract execution, so they stay off the critical path.
Continuity
A direct line to the process developer
RoosterBio developed the 50 L process, and Made Scientific works with RoosterBio under a technology and supply partnership. Secretome contracts with Made Scientific directly and decides what is shared.
Comparability
Planned from the first run
The Technology Transfer Plan sets the comparison to Phase 2 material from the start: the same release panel and characterization on Made Scientific's runs and on Phase 2 retains, with the potency method added when Secretome transfers it. Scope agreed with Secretome.
Yield
Recovery measured at every step
The feasibility and confirmation runs record cell recovery from harvest through the mesh, the Unifuge wash and formulation, so any change rests on data. Our development team works with the Unifuge and can support Secretome's parameter work now.
Communication
One team, visible every week
A dedicated program manager; weekly program calls, a biweekly Joint Project Team and a quarterly Joint Steering Committee; person-in-plant in both directions. Program management fees are waived through technology transfer.
Transfer plan
The transfer package, and how we make it easy
What moves from Secretome and its current manufacturer to East Norriton, and how our team gets first-hand knowledge of the process before the first run.
Process
Documents at current scale
Process description, batch records, process development reports and critical process parameters; the sampling plan and an example CoA; the bill of materials and equipment.
Methods and materials
What the laboratories need
Method protocols, historical performance and reference standards; Phase 2 retains for comparability; master cell bank vials supplied by Secretome.
People
Person-in-plant, both ways
Our process development and MSAT specialists can observe a run at Secretome's current manufacturer during transfer planning, or host Secretome's team at East Norriton for a workshop and the development runs.
Proposed commitment structure
Proof first: Milestone 1 as the first commitment
Secretome has said it will sign once Made Scientific has executed the entire batch process at full scale on STM-01 cells. Milestone 1 is built to do exactly that, so we propose to make it the first commitment.
Milestone 1 as issued
Work Orders 4.0 and 5.0 both run at full 50 L working volume. The confirmation run takes STM-01 to filled drug product on the ARES X20+ and ends with a report for Secretome's approval.
How the commitment would work
- Commit to Milestone 1 now, at , invoiced per work order: half at initiation, half on deliverables.
- Two full-scale runs on STM-01 cells: feasibility, then confirmation through fill and finish, with the data shared as they come.
- Stage Gate 1.1 becomes Secretome's decision point. The initial deposit of and Milestones 2 and 3 commit there.
- If the data show the process is not ready to lock, optimization work is scoped and priced before anyone proceeds, as the proposal already provides.
Fees are unchanged from the proposal. This moves the deposit from execution of the first agreement to Stage Gate 1.1, and is subject to the definitive agreement.
Process
The STM-01 process at East Norriton
Eight unit operations as set out in Appendix A of the proposal, with the critical materials, the in-process controls and the room each runs in.
Durations are representative estimates pending MSAT confirmation. The wash and concentration device is shown as the Unifuge Pilot per the current transfer assumption; the final device is confirmed at Technology Transfer Planning (WO 2.0). Chain of identity and chain of custody are maintained across all steps.
Analytics and release
Release testing, method transfer and stability
The release panel as proposed, executed on cryopreserved drug product, and the work orders that transfer and qualify each method.
WO 3.0
Method transfer
Secretome's methods come into Analytical Development first and are confirmed on STM-01 material from the development runs. Adventitious virus testing is outsourced to a qualified laboratory.
WO 8.0
Method qualification
Quality Control qualifies each method on STM-01 material for GMP release, phase-appropriately under ICH Q2(R2): viable cell count, immunophenotype, sterility, mycoplasma, endotoxin, appearance and extractable volume.
Potency
Transferred from Secretome
The potency assay is in development at Secretome and will be locked for Phase 3. Its transfer and qualification are scoped by change order once the method details are shared.
WO 10.0
Stability
A real-time study to 36 months on engineering-run material, seven timepoints, with T=0 taken from release data. Post-thaw in-use stability is performed elsewhere.
Site
East Norriton, Pennsylvania
Made Scientific's clinical-to-commercial facility outside Philadelphia, at 2900 Potshop Lane, where the STM-01 suite would sit.
85,000square feet, from development to commercial supply
8Grade B/C cleanroom suites
1Grade C closed-system ballroom
1dedicated Grade B fill and finish suite
The STM-01 suite
- Seed and culture roomSartorius BIOSTAT STR 50 L and tower, Unifuge, seed train in biosafety cabinets and stacked incubators, NC-200, scales.
- Fill and finish roomTwo Xiogenix ARES X20+ fillers flanked by two biosafety cabinets. Grade B.
- Cryopreservation roomThree controlled-rate freezers, −80 and −20 °C freezers, 2–8 °C storage, LN2, cryo cart.
- Material and staging roomFlexible staging and support work surfaces.
Representative suite model from the proposal (layout Rev 1, 2 October 2026). Final room assignment and equipment placement are confirmed at Technology Transfer Planning (WO 2.0) and the site visit. A 3D fit-out of the bioreactor and fill and finish rooms is in preparation.
2900 Potshop Lane, East Norriton
Cleanroom suite
Biosafety cabinet and incubators
Proposal 23645-2026 · Version 01
Scope and service fees
The work orders and fees as issued on 2 October 2026. Materials and third-party services are passed through at cost plus 15% and estimated separately.
total service fees (fixed)
Milestone 1: technology transfer and process confirmation
Milestone 2: GMP readiness
Milestone 3: GMP manufacture, batches at
Milestones 1 and 2
Per work order
Half of each work order at initiation and half on submission of its deliverables.
Milestone 3
Per GMP batch
Half at initiation, 30% after completion of manufacture and 20% on issue of the final CoA. Pass-through costs at cost plus 15%.
Initial deposit
Due on execution of the first governing agreement as issued; under the proof-first structure it moves to Stage Gate 1.1. Net 30, with 2% for payment in 10 days.
Payment schedule in full
Additional service fees
Stage Gate 1.1 follows WO 5.0 and Stage Gate 2.1 follows WO 10.0. Program management is waived through technology transfer. Services are governed by the definitive agreements between the parties.
Proposal 23645-2026 · Version 01
Work orders and fees
Timeline
Representative program timeline
As issued in the proposal, in months from program start. Calendar dates are set at contract execution, and durations start when client-supplied materials, inputs and approvals are in.
Timeline
Paths to an earlier first lot
The proposal's timeline is representative. These are the places where time can come out, and the inputs that set the pace.
Paths to an earlier first lot
Where time can come out
- Start analytical method transfer as soon as Secretome's method documents arrive, alongside transfer planning.
- Observe a run at the current manufacturer in the first month, so the feasibility run starts from first-hand knowledge.
- Order long-lead materials as soon as scope is agreed, so the development runs start on time.
- Run aseptic process qualification and QC method qualification alongside the engineering runs, as planned.
What sets the pace
Inputs the later work orders depend on
- A complete transfer package and master cell bank vials at the start.
- The formulation and the wash and concentration device, settled before the confirmation run.
- The potency method, transferred in time for qualification and release.
- The process lock decision, and any optimization it calls for, ahead of the engineering runs.
Team
Made Scientific team
The leadership and business development team for the STM-01 program, with the organizations each person worked for before joining Made Scientific.
Joseph Sinclair
Vice President & Head of Commercial
Previously
David Smith, PhD
Vice President & Head of Development
Previously
Irving Ford
Vice President & Head of Quality and Compliance
Previously
Jill Gliem
Vice President & Head of Technical Operations
Previously
Michelle Ng
Vice President & Head of Portfolio and Program Management
Previously
Karen Wu
Associate Director, Sales & Business Development
Previously
Open questions
Questions to settle together
Inputs that shape scope, price or timing. Most are Secretome's to answer; a few are joint.
- FormulationThe proposal assumes CryoStor CS10; confirm against the 2% DMSO, 5% HSA in Plasma-Lyte formulation discussed in August.Secretome
- Wash and concentrationUnifuge Pilot parameters and the decision date; our development team can help now.Joint
- Potency assayMethod, lock date and transfer timing.Secretome
- Process lockTarget date, and whether any optimization comes first.Joint
- ComparabilityPhase 2 reference lots and retains for side-by-side testing.Joint
- Transfer packageBatch records, development reports, process data, sampling plan, example CoA, bill of materials and equipment.Secretome
- Master cell bankVials, certificate and shipment to East Norriton.Secretome
- Phase 3 demandNumber and timing of batches, cells per bag, and bags per batch.Secretome
- Phase 3 supply modelEast Norriton as a second qualified site or the primary one, and the split of batches.Secretome
- StabilityOne study as proposed, or a study on each of the first three lots.Joint
- Materials estimateBill of materials pricing for development and GMP runs.Made Scientific
- Site visitA date for Secretome's team at East Norriton.Joint
Next steps
Next steps
What it takes to start Milestone 1.