Commercial Manufacturing
of AB-101

Confidential · Updated 14 August 2026

Overview

Overview & Docs

Made Scientific's Princeton campus at 307 College Road East, with the supporting documentation for this proposal.

Aerial view of 307 College Road East, Princeton
307 College Road East, Princeton — the commercial manufacturing campus
Exterior of 307 College Road East, Princeton
The building — single-storey brick construction on a 10.74-acre site
Clear-span interior of the available space at 307 College Road East
Available floor plate — clear-span shell to be fitted out as the seven suites
Made Scientific staff in a Princeton GMP cleanroom corridor
Existing Made Scientific GMP cleanroom, Princeton
57,184ft² building Single-storey, on a 10.74-acre site
46,735ft² available Across three contiguous suites
2025renovation New roof, HVAC and electrical gear
Q4 2027target Made Scientific to establish and build — initial build-out completes Q4 2027 to Q1 2028

Princeton Forrestal Center. Zoned PMOD, which permits laboratories and product development, and the building is already served by HVAC configured for once-through lab air — both material to a cleanroom fit-out. Parking at 4 spaces per 1,000 ft², on-site property management, and minutes from the New Jersey Transit station. Building data as published by the leasing agent; to be confirmed in diligence.

Summary

Responses to your questions

Lead time to seven commercially-licensed GMP suites Technology transfer starts 2027 at 201 College Road East or East Norriton, bridging to Princeton 307 for GMP, PPQ and commercial readiness. Made Scientific’s initial build-out at 307 — cleanrooms, laboratories, warehousing and cold storage — completes Q4 2027 – Q1 2028. The Artiva suite build runs 15–18 months from signature of the commercial agreement.
Cost through Technology Transfer and PLI / first commercial batch, 2027–2030 $10.10M – $17.20M, with program initiation and GMP readiness fee-waived.
Cost per batch at 200 L, 20 batches per suite per year $380K – $430K all-in — $864 to $977 per vial, inside your <$1,000 target.
Suite reservation fee $0, against an agreed minimum annual batch commitment.
StaffingDedicated, not shared. Included in the batch fee.
Raw materials$200K per batch, your assumption, passed through at cost.
Other — semi-annual APVs, stability, storageIncluded in the batch fee.
Made Scientific versus other CDMOs We fund and equip the suites — roughly $85M of build that a standard CDMO charges to you.

Additional finding: the same seven rooms can support approximately 24% more output than the current plan assumes. The supporting analysis follows.

Lead time

Starting now, bridging to 307

The program does not wait on the 307 build. Technology transfer and engineering activities begin in existing licensed space — 201 College Road East in Princeton, or East Norriton in Pennsylvania — and bridge into 307 College Road East as each suite comes ready, carrying the process into GMP readiness, PPQ and commercial supply. Consolidating eFeeder production into 307 on the same path is a proposed move — options remain open, and would give a single-site regulatory footprint. Transfer site and suite configuration are both under joint review; see the supporting documents above.

Site topology — Princeton 307, eFeeder consolidating in
2027Tech transfer starts 201 College Road East or East Norriton, in licensed space
2027–28Initial build-out complete Cleanrooms, labs, warehousing and cold storage — Q4 2027 to Q1 2028
12–15 moArtiva build to GMP ready From signature of the commercial agreement, through fit-out and qualification
2030First commercial batch PLI-ready, on the dates you set

Throughput

Increasing throughput within the same seven rooms

The eFeeder suite achieves approximately 60 batches per year from a 24-day campaign, as only the nine-day bioreactor step occupies the room. Applying the same principle to drug product — converting one DP suite into a seed room serving the other four — raises output from 107 to 133 batches per year within the same seven rooms. An eighth room raises this to 166.

Suite occupancy, seed train in-suite versus decoupled

Sensitivity model

Adjust the assumptions

Every figure in this proposal rests on assumptions that are stated explicitly. The model opens at Artiva's current configuration — five suites with the seed train in-suite. Setting “batches per suite” to 33 reflects a decoupled seed train.

105batches / year
46,200vials / year
5,775patients / year
$898all-in cost / vial within your <$1,000 target
$7,182drug product cost / patient against the $8,000 in your own materials
coversyour commercial reach 250 clinics at 1–2 patients a month = 3,000–6,000 a year

Cost

Program cost

Through tech transfer, PPQ and PLI · 2027–2030

$10.10M – $17.20M

Program initiation and GMP readiness are fee-waived. At a standard CDMO both would be billed.

Technology transfer — ICB, drug product, fill/finish2027
Analytical method transfer, qualification and validation2027–28
Engineering runs and GMP readiness2028
Aseptic process simulation and PPQ campaign2029
BLA support, PLI readiness, first commercial batch2030

Per batch at 200 L · tiered on volume

Annual volumeConversionMaterialsAll-inPer vial
up to 60 batches$230K$200K$430K$977
61 – 120 batches$210K$200K$410K$932
121 – 180 batches$195K$200K$395K$898
over 180 batches$180K$200K$380K$864

Every tier sits within the <$1,000 per vial commercial COGS target Artiva has stated publicly. At eight vials per patient this equates to $6,909 – $7,818 per patient, against the $8,000 in Artiva's own materials.

Suite reservation fee: $0

Charged instead as an agreed minimum annual batch commitment, aligning payment with output rather than with reserved capacity.

Work package breakdown

The same total, by milestone and work order

The identical $10.10M – $17.20M from the previous section, decomposed to work-order granularity through Pre-License Inspection to commercial manufacturing. The splits below allocate the combined lines above across their constituent work orders — they do not add cost.

M1–M8 total: $10.10M – $17.20M. M9 — commercial manufacturing — carries no fixed fee; it is priced per batch under the volume-tiered schedule above, and forecast by configuration below.

Assumption stated explicitly: the technology-transfer-versus-engineering-run split within M2/M4, and the ICB/DP/fill-finish split within M6 PPQ, are Made Scientific's own allocation of an already-stated combined range — not independently estimated line items. Each work order can be requoted independently once the process points in the Technical Points of Clarification document are confirmed.

Commercial forecast

Volume-based discount, by configuration

Structured as a volume-discount schedule: as committed volume increases, the batch fee steps down. The schedule is anchored to Made Scientific's throughput options rather than to an Artiva demand forecast, as drug product volumes have not been shared. It therefore models cost against a rising share of each configuration's capacity.

Illustrative yearConfigurationCeiling CommitmentCommitted batchesBatch fee Minimum annual fee$/vial
2030 (PLI & launch)Option 110750%54 $230K$12.42M$977
2031Option 213365%86$210K $18.06M$932
2032Option 316680%133$195K $25.93M$898
2033+Option 426590%238$180K $42.84M$864

The fee steps down as committed volume scales — $230K → $210K → $195K → $180K per batch — and every step remains inside your own <$1,000/vial commercial COGS target. Materials pass-through is additional at $200K/batch and is not part of the minimum fee.

Assumptions stated explicitly, not implied
  • The year mapping (2030→2033+) is Made Scientific's proposed adoption sequence, not a commitment you have made or a demand forecast you have provided.
  • Commitment levels (50% / 65% / 80% / 90%) are illustrative, structured to rise as the relationship matures — not yet negotiated with you.
  • Batch fees are read from the tier schedule at each year's committed volume, not at the configuration's ceiling — pricing reflects what you actually commit to, not the capacity available. Matches the methodology of the ramp slider below.
  • Real adoption timing depends on your actual demand, which has not been shared with Made Scientific as of this estimate.

Five-year volume ramp

Each year's volume can be set independently; no ramp shape is assumed. Fee per batch follows the tier schedule applied throughout this proposal.

Commercial model

Commercial model comparison

A standard CDMOMade Scientific
Facility build-outCharged to you — est. $30M–$40MAbsorbed
Suite fit-out and process equipmentCharged to you — est. $45M–$55MAbsorbed
FTEs / laborHire and manage your own — est. $7M–$11M/yr for a dedicated ~45–55 FTE teamIncluded in the batch fee — no separate hire
Suite reservation feeCharged, non-refundable$0 against a volume commitment
Program initiationChargedWaived
GMP readiness (APQ, CQV, equipment maintenance & calibration, EMPQ, etc.)ChargedWaived
Dedicated program managementCharged — est. $15K/monthIncluded
CapacityShared, multi-clientDedicated suites

A seven-suite build is roughly $85M — our own estimate of $30M–$40M facility shell plus $45M–$55M suite fit-out and process equipment. Made Scientific funds both. FTEs are dedicated and not billed separately; their cost sits within the per-batch fee shown under Program cost, not in this comparison. Artiva commits to volume rather than to capital.

Appendix

Assumed Process Flow

Assumed process flow, feeder production through drug product

eFeeder is consumed at every expansion step — the ICB bag phase, the seed train, and the 200 L top-ups. It is not one of the seven rooms as originally specified. Consolidating production into Princeton 307 alongside the rest of the process is a proposed move — options TBD, with the specific suite arrangement under joint review (see Documents).

Facility

Facility Layout Concept

Princeton — 307 College Road East. EwingCole / EC Build's cleanroom concept for the seven-suite expansion, with Grade B cores inside Grade C shells and unidirectional Annex 1 flow already designed in. Open the source PDF →

307 College Road East cleanroom layout concept — EwingCole / EC Build

Seven uniform manufacturing suites along a Grade C supply corridor (top) feeding each suite's MAL/PAL IN, and a Grade D return corridor (bottom) taking MAL/PAL OUT — each suite drawn with a Grade B core inside the Grade C shell, accommodating either grade as the production standard. CNC support (warehouse, shipping & receiving, visual inspection) sits north of the supply corridor; QC and administrative space to the south.

Appendix

Suite floor plan and equipment

Suite floor plan, decoupled configuration, Princeton 307

Schematic, not to scale, based on the 307 layout — the decoupled configuration, with suite 2 converted from drug product to a shared seed room. Equipment fit-out remains an open item; this reflects Made Scientific's modeling assumptions pending confirmation.

Appendix

Key equipment

Process equipment referenced throughout this proposal, funded and absorbed by Made Scientific.

Sartorius Biostat STR 50 L single-use bioreactor
Sartorius Biostat STR 50 L
Single-use bioreactor — feeder and ICB expansion
Sartorius Biostat STR 200 L single-use bioreactor
Sartorius Biostat STR 200 L
Single-use bioreactor — drug product expansion
CARR UniFuge Pilot centrifuge
CARR UniFuge Pilot
Continuous centrifugation — harvest and volume reduction
Rad Source RS 1800-Q X-ray irradiator
Rad Source RS 1800-Q
X-ray irradiator, 100 Gy — transfers from Artiva
Aseptic Technologies Crystal Pure M1 fill line
AT Crystal Pure M1
Closed-vial fill line — Grade B isolator, 3.0–5 mL AT-Closed Vial
PCBI incubator
PCBI Incubator
Controlled-atmosphere culture support

The team

Program team

Made Scientific leadership, business development, Scientific Advisory Board and Board of Directors. The engagement is structured as an operating relationship rather than a supplier arrangement.

Leadership

Syed T. Husain
Syed T. HusainChairman & Chief Executive Officer
Joseph Sinclair
Joseph SinclairVice President & Head of Commercial
David Smith, PhD
David Smith, PhDVice President & Head of Development
Irving Ford
Irving FordVice President & Head of Quality and Compliance
Jill Gliem
Jill GliemVice President & Head of Technical Operations
Michelle Ng
Michelle NgVP & Head of Portfolio and Program Management
Kelly Brennan
Kelly BrennanVP & Head of Human Resources and Administration
Najah Z. Ellison
Najah Z. EllisonVP & Head of Finance and Controlling

Business Development

Karen Wu
Karen WuAssociate Director, Business Development
Simran Kaur
Simran KaurDirector, Sales & Business Development

Scientific Advisory Board

Miguel Forte, M.D., Ph.D.
Miguel Forte, M.D., Ph.D.CEO, Kiji Therapeutics · President, ISCT
Paul K. Wotton, Ph.D.
Paul K. Wotton, Ph.D.CEO & Chairman, RBL
Shishir Gadam, Ph.D.
Shishir Gadam, Ph.D.CTO, Marea Therapeutics
Young K. Hong, M.D.
Young K. Hong, M.D.Dir. Clinical Research & Cellular Therapy, MD Anderson at Cooper

Board of Directors

Syed T. Husain
Syed T. HusainChairman & Chief Executive Officer
Edward J. Dolan
Edward J. (Ted) DolanBoard Member
Harry S. Rathore
Harry S. Rathore, Ph.D.Board Member
Soyoung Park
Soyoung ParkManaging Director, Strategy Planning — GC Corporation
Jin Pyun
Jin PyunCEO, GC Ventures
Yonghoon Kim
Yonghoon KimCFO, MOHABI Investment USA

Next steps

  1. Confirm the process assumptions. A short technical session on seed-train duration, suite turnaround, NK seed density, feeder/vial thaw and expansion, and DP storage duration would replace our estimates with your numbers and tighten the ±30%.
  2. Resolve the suite configuration. eFeeder consolidating into Princeton 307 raises open design questions — one room or two for feeder + ICB, shared vs. per-suite harvest, and enlarged multi-suite rooms vs. individual suites for throughput. See the Technical Points of Clarification document.
  3. Capacity reservation. Secures a technology transfer slot and suite capacity, credited in full against work orders.
  4. Detailed proposal at work-order level, with a full Gantt to first commercial batch.