Your TIL therapy program is advancing. The manufacturing challenge is delivering autologous, patient-specific production with the speed, precision, and GMP compliance that personalized cell therapy demands — every batch, every patient.
Iovance's Amtagvi (lifileucel) FDA approval validated TIL as a therapeutic modality. The next wave of TIL programs — 11 developers, 8 clinical stage — needs manufacturing infrastructure to match. Made Scientific partners with TIL therapy developers to deliver autologous manufacturing from fresh tumor processing through rapid expansion and patient infusion, all within the 14–22 day vein-to-vein window.
End-to-end TIL manufacturing support — from fresh tumor receipt through patient infusion — with the speed and precision that personalized therapy requires.
Infrastructure designed for the 14–22 day TIL timeline. Process scheduling, cleanroom availability, and QC release aligned to vein-to-vein urgency.
TIL isolation methods, REP optimization, IL-2 and media formulation, feeder cell preparation, and expansion protocol development tailored to your program.
Cleanroom suites designed for autologous manufacturing — dedicated per-patient processing, full chain-of-identity, and regulatory-ready batch records.
Rapid-release QC testing, potency assays, sterility, viability, identity (flow cytometry), and release specs designed for the compressed TIL timeline.
IND-enabling packages, CMC documentation, and regulatory strategy — informed by the Amtagvi approval pathway and evolving FDA guidance.
Capacity planning for commercial TIL manufacturing — from single-patient slot scheduling to multi-suite parallel production as volume grows.
TIL manufacturing is uniquely complex. Fresh tumor specimens arrive with a ticking clock — the manufacturing window is measured in days, not weeks. Every batch is patient-specific, with biological variability built into the starting material.
The Amtagvi approval validated TIL therapy as a modality. But commercial-scale TIL manufacturing — with consistent expansion, rapid turnaround, and reproducible quality — is the next bottleneck the industry must solve.
Discuss your TIL programRapid processing of surgical tumor specimens under GMP conditions. Time-critical — manufacturing begins within hours of receipt.
Fragment-based or enzymatic digestion for TIL isolation, followed by IL-2-driven initial expansion to identify and select reactive TIL populations.
Scale TILs from millions to billions in 14 days using anti-CD3, IL-2, and irradiated feeder cells. The critical step that determines clinical dose.
Cell harvest, wash, formulation for infusion, and rapid QC release — sterility, viability, identity, potency — all within the vein-to-vein window.
Tight coordination between manufacturing site, clinical site, and logistics — the patient's lymphodepletion schedule must align with manufacturing completion.
Our GMP facilities are designed specifically for cell therapy and actively support concurrent TIL and cell therapy programs across development stages.
Made Scientific Headquarters
Located at the heart of innovation in Princeton, New Jersey, our 60,000 ft² facility is equipped to take your therapy from early development to GMP manufacture.
Made Scientific Clinical Production
Strategically designed for flexibility, our Newark site offers 15,000 ft² of GMP-ready space to support client-dedicated and hybrid operational models.
Workforce Development & Training
We're investing in the future of cell therapy through both hands-on and digitally accessible GMP-inspired training. Located on the NJIT campus, our center has supported over 275 trainees across industry and academia.
Flexible engagement models designed for the unique demands of autologous, time-critical TIL manufacturing.
All Clients
Full-service TIL manufacturing in Made's GMP suites. From tumor receipt through product release — your team retains process oversight while we execute.
Mid-to-Late Stage Clients
Your scientists embedded alongside ours for tech transfer and process optimization. Critical for TIL programs where process knowledge and biology are deeply intertwined.
Late-Stage and Commercial Clients
Dedicated TIL suites designed around your program — from tumor processing workflows to expansion systems and rapid QC release protocols.
We manufacture autologous cell therapy products. Our teams understand patient-specific processing, chain-of-identity requirements, and the operational discipline required when every batch is a single patient's treatment.
Manufacturing infrastructure designed for rapid turnaround. Cleanroom scheduling, QC release, and logistics coordinated around the patient — not the other way around.
Purpose-built GMP facilities with capacity to scale from clinical trials to commercial supply. Multi-suite parallel manufacturing for growing patient volumes.
Process development, manufacturing, QC, and regulatory under one roof. No handoffs between departments — your program team stays consistent from development through every patient batch.
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