Workshop hub · Monday 28 September 2026 · 10:00 to 17:00 ET · MADE Scientific, East Norriton
RTX-001 Pivotal Process Workshop
The CP-2 (Ruby) process and its eight changes, MADE's capacity model, the facility options, the analytical
and development work, the comparability design and the technology-transfer plan, prepared by MADE Scientific for
Resolution Therapeutics, with the record of what the room decides.
Resolution Therapeutics × MADE Scientific · Confidential
The development team, MADE ScientificManufacturing operators in a cleanroom suite, MADE Scientific
Monday 28 September 2026
The day: 10:00 to 17:00 at East Norriton
Resolution presents the CP-2 (Ruby) process; MADE brings the process wall, the live capacity model,
the analytical and development plans and the transfer timeline. Each block closes on a decision, an action and an owner,
captured in the workshop record.
VenueMADE Scientific, 2900 Potshop Lane, East Norriton, PA 19403. Visitor parking on site.
RemoteA Microsoft Teams link for UK-based Resolution staff; the analytical block is timed so the UK analytical team can join in their afternoon.
FormatHorseshoe tables, the printed process wall with the eight change cards, the working canvas on the TV, the live capacity model, and the unit-operation worksheets.
Flow, clocks and sampling, unit operation by unit operation
Resolution's pivotal process flow redrawn from the September 2026 process document and the Workshop Briefing
Pack: starting material, unit operation with its clock and grade, in-process samples, key equipment, and the change
marker against CP-1. Select a unit operation on the diagram or in the strip below it to open its card.
Resolution-stated clocksMADE working estimates, rehearsal to confirmC1 to C8 change markersOpen as imagePDF leave-behind
Day 4 elapsed time is not a fact until it is rehearsed.
Sources: Resolution "US CDMO - Pivotal Process Detailed" document (3 to 4 Sep 2026); Resolution Workshop Briefing Pack
slides 4 to 9 (4 Sep 2026); Resolution and MADE pre-briefing call (21 Sep 2026); MADE working estimates (September 2026).
Equipment named is the CP-2 process equipment as stated by Resolution. Flowfect, Ares X20, FACSLyric and ELLA are to be procured by MADE;
MADE has demonstrated the Ares X20 and has staff with prior Kytopen experience.
CP-1 to CP-2
The eight changes, and the mRNA supply change beside them
What changes, why Resolution is making the change, MADE's position of record, the risk MADE sees, the study
that closes it and the question MADE brings back to the room. Process lock is December 2026, with every change subject
to Resolution's final data review.
Sources: Resolution Workshop Briefing Pack slides 4 to 9; Resolution process document unit-operation table;
pre-briefing call 21 Sep 2026; MADE response deck. Risk ratings are MADE's working view for discussion.
Manufacturability
Live capacity model: Day 4 choreography, equipment, incubators, staffing, facilities, ramp
Every number in the model is computed from the process data: a hold-constrained Day 4 scheduler, incubator
occupancy, QC load, the five facility options and the commercial ramp. Change an input and the whole picture recomputes.
The basis is stated on every figure: MADE working durations or Resolution-stated durations, a 250- or 336-operating-day year.
Day 0 to Day 5 lanes for staggered starts, drawn from the process data with a simple back-to-back chain. The live model above is
the source for any figure quoted; this drawing shows the shape of a pivotal week.
Illustrative only. Durations from the process data; MADE working estimates for Day 4 are not confirmed until rehearsed.
Model figures used on this page
Where a figure on this page comes from the model it is marked with a dotted underline and an asterisk; hover for its basis. The table
lists each figure, its basis and where in the model output it comes from.
Where it runs
Five facility options, one process
The CP-2 workstation is a Prodigy, a Rotea, an electroporator and an Ares, with incubators sized to the
starts in culture. Each option below is read two ways in the model: one start per workstation per day, and 24-hour
processing. East Norriton is the option that scales without moving; the choice is Resolution's.
Existing · option 1
Princeton 201, Suites 1 to 4
201 College Road East, Princeton, NJ
Existing cleanroom suites at MADE's Princeton site, about 300 sq ft each; QC laboratories for environmental, microbial, in-process and release testing on site.
Rated at 2 starts per week and 100 batches per year per suite; the model reads two suites assigned to the program with one workstation and three incubators each.
On the model's incubator math the pair sustains about 1 start per day; a five-start week needs 6 to 8 incubators in culture at once.
300sq ft per suite
2 / wkstarts per suite, rated
100 / yrbatches per suite, rated
Planned · option 2
Princeton 201, Suite 8 ballroom
201 College Road East, Princeton, NJ
A 1,292 sq ft ballroom suite in the same building, rated at 25 starts per week and 1,250 batches per year with 5 Prodigy, 25 incubators, 10 Rotea and 5 electroporators.
The model reads five workstations and the rated incubator count: 4 starts per day, incubator-bound, 1,000 batches per year on a 250-day basis (1,344 on 336 days).
Covers the first two years of the V3 ramp (343 and 1,000 patients per year); 2,500 per year needs about 10 starts per day and moves past it.
1,292sq ft
25 / wkstarts, rated
4 / daystarts, model, incubator-bound
Build · option 3
Princeton 307
307 College Road East, Princeton, NJ · adjacent to 201, same campus
A 46,000 sq ft clear-span shell with room for up to 8 ballrooms; 10 to 40 starts per day depending on the fit-out; the commercial-scale option on the Princeton campus.
The model reads 4 of 8 ballrooms fitted at 10 workstations each: 40 starts per day on the one-start-per-workstation rule, 10,000 batches per year on a 250-day basis; no source incubator count, so the model reports the requirement (207).
Same site team, quality system and QC laboratories as 201, a short walk away.
46,000sq ft shell
up to 8ballrooms
10 to 40starts per day
Existing, dedicated · option 4 · the option that scales without moving
East Norriton Grade C ballroom with Grade B side rooms
2900 Potshop Lane, East Norriton, PA · today's venue
About 8,900 sq ft with 5 biosafety cabinets, on the 85,000 sq ft site MADE acquired on 19 September 2026 (145 GMP batches to date; 8 Grade B/C cleanrooms, 1 Grade C ballroom, 1 Grade B fill-finish suite, 30,000 sq ft of expansion space).
Rated at 36 to 72 starts per week, 1,800 to 3,600 batches per year. The model reads 8 workstation columns: 8 starts per day on the one-start-per-workstation rule, 15 per day with 24-hour processing under MADE working durations, 4 per day under Resolution-stated durations.
2,000 batches per year at 8 per day on a 250-day basis (2,688 on 336 days). Covers the V3 ramp to 2,500 patients per year on the 24-hour reading; standing second and third shifts are planned here.
Prodigies, Rotea, electroporator and Ares stations sit in the ballroom; the Grade B side rooms take the open steps.
2900 Potshop Lane, East Norriton, PA · on the same site as option 4
Up to 8 ballroom suites, designed EU Annex 1-ready, about 15 months from go. No rated throughput exists in any source.
The model's planning assumption: each suite matches the existing ballroom (8 workstations), 64 starts per day on the rule reading, which covers 10,000 patients per year (40 starts per day on a 250-day basis) with headroom for the longer Resolution-stated Day 4.
The path from option 4 to option 5 is an expansion on one site, with one quality system and one team, not a move.
Sources: MADE facility summaries and the V3 proposal for rated figures; the capacity model (06_model) for the rule and 24-hour readings; Contract Pharma, 21 Sep 2026, for the East Norriton acquisition facts. Suite-level readings without a source incubator count show the incubators the option would need.
Analytical and sampling plan
In-process controls, release, characterization, hold points and the gaps to close
Sixteen sample points from the process data, the ten-test release panel with its turnaround, the characterization
and potency candidates, and the seven hold points that need windows. No sample volume, specification or action limit has
been shared yet, so every volume reads "TBD" and every limit shown is a literature precedent or a patent target, labeled as such.
Release panel and critical path
Release samples are drawn at formulation on Day 4 into 5. Sterility at 7 days sets the earliest release at about Day 11 to 12 after start;
the product is cryopreserved, so release gates shipment to the collection-and-thaw network, not infusion timing. A validated rapid
sterility method would move the critical path to the 2 to 3 day tests.
Extended characterization and potency candidates
Three tiers: release, for-information during the pivotal (building potency assurance), and an extended-characterization
comparability suite. Phagocytosis is proposed as a kinetic readout with an engineered-versus-non-engineered contrast, because bead
uptake alone did not separate monocytes from Day 7 macrophages in the MATCH GMP process (Fraser et al. 2017).
Hold points that need windows
Hold point
Condition
Readouts
Design
Data status
mRNA after thaw
Weldable pouch, Day -15 to -1
Integrity, concentration
Hold to maximum pre-use time
None shared
Incoming leukapheresis
Transit and hold before selection; receipt within 48 h of collection
Viability, CD14+ count
Shortest and longest transit, at least 3 donors
None shared
Pre-electroporation
Post-Rotea in electroporation buffer
Viability, downstream transfection efficiency
Longest Day 4 queue
None
Post-electroporation rest
2 to 6 h window
Viability, transgene mRNA, IL-10
Freeze at 2, 4, 6 h (Study 1)
Small-scale healthy-donor data at Resolution
Drug product before freeze
CryoStor CS10; 10 mL bags and 1 mL vials
Post-thaw viability, potency
Maximum DMSO exposure, bag and vial
None
Drug product long term
LN2 vapor
Viability, count, identity, potency, sterility
Engineering and PPQ lots, 5 time points
Schedule only (0, 3, 6, 12, 18, 24 months)
Post-thaw and shipping
Thaw to dose; dry shipper
Viability, count, potency
Maximum in-use time (2 to 8 C, 0 to 8 h); simulated shipment
Precedent only (Transfusion 2003)
Sources: MADE response deck s28 (hold points), V3 appendix C (stability schedule), Resolution Workshop Briefing Pack s9 (recovery data), Fraser et al. 2017, Transfusion 2003 (PMID 12631303).
Gaps named in the source documents
QC fill and retains for an autologous product
About 20 x 1 mL QC vials are filled on the Ares after the bags, from the same formulated bulk. Vials and bags are frozen in the same
controlled-rate freezer runs with product probes in both, and paired on at least 3 runs for viability, recovery, identity and potency.
Use
Vials
Post-thaw release tests
6
For-information potency tier
4
Retest reserve
4
Retain
4
Investigation spare
2
Illustrative allocation (MADE response deck s37), adjusted once the tiered assay list and validated sample volumes are confirmed. Stability pulls come from engineering and PPQ lots only.
Development work packages
How MADE would run the development work, and the packages it proposes
A development work package at MADE is a gated study: a one-page charter agreed with Resolution, a protocol with
pre-registered acceptance criteria and a decision rule, a design sized to the decision, execution in MADE's development
laboratories with Resolution staff embedded where useful, interim data at two weeks, a report at four weeks, under the program
governance (dedicated project manager, weekly 1:1, bi-weekly joint project team, quarterly joint steering committee, RAID log).
The eight one-page DOE plans (D-1 to D-8) are in the work-packages and DOE plans PDF. Durations in the plans are MADE planning figures except where a Resolution figure exists.
Opportunities MADE sees in the process map
Beyond the packages Resolution asked about, the published record and the process data point to a set of unlocks worth discussing.
Each is stated with its evidence and its risk; none is a commitment.
Comparability and regulatory
Resolution's Studies 1 to 4, and what MADE would add
The exercise runs from the EMERALD process (CP-1, UK, MS-1 mRNA) to the pivotal process (CP-2, MADE, MS-2 mRNA)
with three confounded change areas and no feasible direct site-to-site comparison. The package that carries it is a
characterization-heavy, statistically pre-registered comparability protocol agreed with FDA at pre-IND, with a site-and-scale
bridge added to the four studies.
Resolution's studies
What MADE would add
Working with FDA. Agree the protocol, the run count, the statistics and the tiered assay strategy at pre-IND on the back of the
positive Type D meeting; frame the changes with a totality-of-changes characterization set; anchor to the FDA draft guidance on
manufacturing changes and comparability for cellular and gene therapy products (July 2023), the draft potency assurance guidance
(December 2023) and ICH Q5E. The BLA rests on pivotal efficacy only, so the comparability package must stand on its own.
Technology transfer
A front-loaded transfer that finishes by the end of 2027
Analytical transfer from January 2027, purchase orders before April, operator training and unit-operation
repetitions at the Resolution site before April, then practice runs, one verification run, and comparability runs that double
as the IND-enabling engineering runs. Move the levers to see the knock-on to the IND readiness date.
Resolution plans 4 to 5 at pre-IND and would like an N of 10.
Each run occupies one workstation for a planning placeholder of 4 weeks including release testing.
Resolution's ask is not before April 2027; analytical transfer stays at January 2027.
A failed verification run costs 4 to 5 weeks or more; this shows where that lands.
IND readinessDec 2027reports, statistics and IND authoring complete
Against a start-of-2028 INDon planResolution: US IND at the start of 2028; pivotal Q1 2028
Comparability block16 wk4 runs, 1 in parallel
Runs at MADE before comparability3practice and verification runs (up to 7 end-to-end runs observed or performed counting the Resolution-site runs)
Risks and mitigations
Resolution's four questions
MADE's responses to Q1 to Q4
Resolution asked four questions in the Workshop Briefing Pack. The responses below are MADE's draft positions for
the room, with the evidence behind each; the full text is in the leave-behind after the workshop.
Questions for Resolution
What MADE needs to know to plan with confidence
Thirty-five questions from the process data, grouped roughly in process order. Tick each one as it is answered
in the room; the ticks stay in this browser and the answers go in the action log.
Workshop record
Decisions, actions and owners
One row per decision or action: block, item, decision or action, owner, date and who said it. Rows are kept in this
browser; export the log as CSV at each break and at close. Wall photographs are posted at each break; the leave-behind list is
below.
Action log
Stored in this browser only (localStorage). Export before closing the day.
Photo wall
Wall photographsPhotographs of the process wall and the eight change cards are taken at each break (12:30, 14:50 and 17:00) and posted to the Teams chat within five minutes; they are added here with the leave-behind.
Leave-behind within 24 hours
All via this hub's Documents section and by email to Resolution by 17:00 on Tuesday 29 September.
The team
Who Resolution is working with
Development, technical operations, quality, regulatory, MSAT, analytical, manufacturing, program management and
commercial each carry a piece of the program from the first work package. The people below are the ones who would carry it.
Resolution Therapeutics attending
Documents
The leave-behind
Documents open behind a second sign-in with the same credential. The action log, wall photographs, worksheets and the
agreed model inputs are added within 24 hours of the workshop.
