Made Scientific
CAR-T cell therapy manufacturing team

CAR-T Cell Therapy Development & GMP Manufacturing

End-to-end CAR-T manufacturing — from leukapheresis processing through T cell activation, viral transduction, expansion, and cryopreservation. Autologous and allogeneic programs, from IND-enabling through commercial supply.

CAR-T is the most mature cell therapy modality — 312 companies, 185 clinical stage, 317 active trials. Manufacturing scale, vector supply, and vein-to-vein time are the differentiators. Made Scientific provides comprehensive manufacturing support for autologous and allogeneic CAR-T programs with the speed, precision, and GMP compliance your program demands.

  • • Process development & CAR construct optimization
  • • Viral vector supply (lentiviral & retroviral)
  • • GMP manufacturing (autologous & allogeneic)
  • • Analytical & QC (CAR expression, VCN, potency)
  • • Commercial scale-up & multi-product suites
  • • Regulatory support (pre-IND through BLA)
Contact us to discuss your CAR-T program

Our Capabilities

Comprehensive manufacturing support for autologous and allogeneic CAR-T programs — from process development through commercial-scale production.

Process Development

Process Development

T cell activation optimization, transduction protocol development, expansion kinetics, and process lock — tailored to your specific CAR construct.

  • • Activation and transduction optimization
  • • Expansion kinetics and media strategy
  • • Process lock and tech transfer readiness
  • • Construct-specific protocol development
Viral Vector Supply

Viral Vector Supply

Lentiviral and retroviral vector production — or partnership-based procurement — ensuring your program is never bottlenecked by vector availability.

  • • Lentiviral and retroviral production
  • • Partnership-based procurement
  • • Titer and potency qualification
  • • Supply chain coordination
GMP Manufacturing

GMP Manufacturing

Purpose-built cleanroom suites with full chain-of-identity/chain-of-custody tracking — critical for autologous patient-specific products.

  • • Autologous and allogeneic workflows
  • • Chain-of-identity/chain-of-custody tracking
  • • Single-use and closed-system processing
  • • Campaign planning and execution
Analytical & QC

Analytical & QC

CAR expression (flow cytometry), transduction efficiency, T cell phenotyping, potency assays, sterility, VCN, and release testing.

  • • CAR expression and VCN testing
  • • T cell phenotyping and potency assays
  • • Sterility and release testing
  • • Method development and qualification
Commercial Scale-Up

Commercial Scale-Up

From single-patient clinical batches to high-throughput commercial manufacturing — process comparability, capacity planning, and multi-product suites.

  • • Process comparability across scales
  • • Multi-product suite design
  • • Capacity and throughput planning
  • • Commercial readiness assessment
Regulatory Support

Regulatory Support

IND-enabling manufacturing, CMC documentation, process validation, and regulatory strategy — from pre-IND through BLA filing.

  • • CMC strategy and documentation
  • • IND, IMPD, and BLA contributions
  • • Process validation support
  • • Health authority interaction preparation

Vein to Vein, Under One Roof

Every step of CAR-T manufacturing — from apheresis material receipt to cryopreserved product — executed in our GMP facilities with full chain-of-identity tracking.

01

Apheresis Receipt

Incoming material processing, T cell enrichment, and quality assessment

02

T Cell Activation

Anti-CD3/CD28 activation, cytokine conditioning, and activation confirmation

03

Viral Transduction

Lentiviral or retroviral CAR gene transfer with transduction efficiency monitoring

04

Expansion

CAR-T cell expansion to clinical dose in bioreactors with phenotype monitoring

05

Formulation

Harvest, wash, formulation for cryopreservation with in-process QC

06

Cryo & Release

Controlled-rate freezing, QC release testing, storage, and distribution

Our Facilities

Our GMP facilities are designed specifically for cell therapy and actively support concurrent programs across development stages.

Commercial Manufacture & Development Center of Excellence

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.

Manufacture & Hybrid Client-in-Plant Operations

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.

Made Scientific Foundry: Workforce Development & Training Center

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.

Made is easy to work with. We've got your back.

Flexible engagement models for every stage — from early process development through multi-product commercial manufacturing.

Traditional & Dedicated Service

All Clients

Full-service CAR-T manufacturing. We execute the entire vein-to-vein process in our GMP suites — your team maintains oversight, we deliver product.

Hybrid Client-In-Plant Operations

Mid-to-Late Stage Clients

Your scientists work alongside ours during tech transfer and process optimization. Builds deep manufacturing knowledge while maintaining your process expertise.

Custom Build-outs & Partnerships

Late-Stage and Commercial Clients

Dedicated CAR-T suites configured for your program — from closed-system processing to custom automation and high-throughput commercial capacity.

Why Made Scientific for CAR-T

Active CAR-T programs

Currently advancing autologous and allogeneic CAR-T programs from process development through GMP manufacturing, with real-world experience across the vein-to-vein workflow.

Vector supply integration

In-house and partnership-based vector procurement ensures your CAR-T program is never bottlenecked by vector availability — coordinated with manufacturing timelines.

Built for autologous speed

Purpose-built infrastructure for patient-specific manufacturing — chain-of-identity tracking, dedicated suites, and scheduling systems designed for vein-to-vein urgency.

Commercial-ready scale

Multi-product suites and high-throughput capacity planning — structured to support the transition from clinical batches to commercial manufacturing volumes.

Ready to Advance Your CAR-T Program?

Have a question for our sales team? Contact us to explore how our expertise and capabilities can help you achieve your goals.

Contact Us
Scientist in Made Scientific cleanroom