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