Syenex Partnership

Next-generation vector technology for rapid, cost-effective T cell therapy manufacturing, delivered in partnership with Syenex

MadeFast™: A Single-Step CAR-T Manufacturing Platform, Powered by Syenex RapidCell™

A Next-Generation Framework for Reducing Manufacturing Cost, Complexity, and Time

MadeFast™ is Made Scientific's single-step CAR-T manufacturing platform, designed to consolidate enrichment, activation, and transduction into a single step early in the manufacturing process. MadeFast is technology-agnostic by design: it defines the streamlined workflow, while the specific enabling vector can be selected based on performance and program needs. In its first configuration, MadeFast integrates Syenex's RapidCell™ — engineered to simultaneously activate and transduce T cells — to deliver a faster, simpler, and more cost-effective path from development through GMP manufacturing.

Why it matters: Conventional CAR-T manufacturing requires separate enrichment, activation, and transduction steps that add cost, time, and variability
What’s different: RapidCell™ combines T cell activation and transduction into a single step, eliminating the need for separate activation reagents and potentially removing the T cell enrichment step entirely
Where we are: Initial proof-of-concept data demonstrate superior transduction efficiency and comparable or higher CAR+ cell yields versus conventional methods
What’s next: Customer-accessible MadeFast™ manufacturing process under active development, with availability planned for 2026

How RapidCell™ Technology Fits into Cell Therapy Manufacturing

Initial focus: CAR-T and TCR workflows

The MadeFast™ platform is designed to integrate directly into existing cell therapy manufacturing workflows, replacing multiple upstream processing steps with a single, consolidated operation. In its first configuration, MadeFast uses Syenex's RapidCell™ as the enabling vector technology for the consolidated activation-transduction step.

Consolidate activation and transduction to reduce process complexity and operator touchpoints
Enable transduction of non-enriched cell populations, potentially eliminating CD4/CD8 selection
Maintain product quality with high viability, balanced T cell subsets, and strong CAR expression at harvest

A simplified manufacturing workflow

RapidCell™ combines activation and transduction into one step on Day 0, eliminating the need for separate activation reagents like TransAct. The result is fewer process interventions, less hands-on labor, and a shorter critical path from apheresis to drug product. In total, MadeFast compresses the manufacturing timeline to approximately two days — versus 8–10 days for conventional autologous CAR-T processes.

Higher transduction efficiency at lower vector doses

Proof-of-concept data demonstrate that RapidCell™ achieves higher CAR expression and MFI than conventional lentiviral transduction at equivalent MOIs. At MOI = 1, RapidCell™ produced 30% more viable CAR+ cells at harvest — a direct lever for reducing cost of goods through lower vector consumption.

A pathway to eliminate T cell enrichment

Initial data show RapidCell™ can transduce unfractionated PBMCs at greater than 97% efficiency, supporting the feasibility of removing the CD4/CD8 selection step. Eliminating enrichment reduces reagent costs, processing time, and cell loss.

CDMO execution from development through GMP

Made Scientific provides end-to-end process development, tech transfer, and GMP manufacturing services optimized for the MadeFast™ workflow. Flexible engagement models support programs from early feasibility through clinical and commercial supply.

Syenex RapidCell™: next-gen vector technology for T cell therapies

Lentiviral and retroviral vector systems engineered for simultaneous activation and transduction
Up to 97% CAR transduction of unfractionated PBMCs without CD4/CD8 enrichment, with higher per-cell CAR density (MFI) than conventional lentiviral methods
Projected to meaningfully reduce cost of goods per dose and shorten vein-to-vein time through process consolidation, fewer operator touchpoints, and lower vector consumption
Maintains balanced CD4/CD8 ratios and robust activation markers across conditions, supporting product quality at harvest

Integrated CDMO services, built for rapid manufacturing

GMP-ready process development, technology transfer, and manufacturing at Made Scientific's Princeton, NJ facility
Phase-appropriate quality systems and documentation aligned with U.S. FDA and EU regulatory requirements
Flexible partnership models — from fee-for-service to dedicated capacity — tailored to program stage
Structured comparability protocols to support transition from conventional to MadeFast™-based manufacturing

Proof-of-Concept: RapidCell™ Collaboration Results

In their first collaboration study, Made Scientific evaluated Syenex's RapidCell™ Lentiviral Vector as the enabling technology for a consolidated, single-step CAR-T manufacturing workflow. The results demonstrate measurable advantages in transduction efficiency, CAR+ cell yield, and process simplicity — establishing RapidCell™ as a strong candidate within Made Scientific's MadeFast™ platform.

Key findings

97%+ CAR transduction in unfractionated PBMCs without CD4/CD8 enrichment
30% more viable CAR+ cells at harvest versus conventional methods at MOI = 1 — supporting reduced vector consumption and lower cost per dose
≥97% viability across all conditions at Day 8 harvest (reaching 97–99.5%)
Balanced CD4/CD8 ratios preserved across all experimental conditions
Higher per-cell CAR density (MFI) than control vector at every MOI tested

Made Scientific and Syenex Forge Technology Partnership to Transform T Cell Therapy Manufacturing

In September 2025, Made Scientific and Syenex announced a technology partnership to advance the scalability and efficiency of engineered T cell therapies through the use of Syenex’s bioengineering systems, UltraCell™ and RapidCell™, providing improvement in gene delivery efficiency and engineering timelines.

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