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Early Phase Manufacturing

Early-Phase RNA & LNP Manufacturing, Built for Speed and Quality

GMP-like processes and controls to support preclinical and IND-enabling programs
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CDMO Early Phase Manufacturing
Crystal NAX provides early-phase RNA manufacturing services designed to bridge the gap between research and clinical development. Our platform applies GMP-like principles, standardized workflows, and rigorous quality controls to deliver high-quality RNA and LNP materials suitable for advanced preclinical, IIT and IND-enabling studies.

By combining flexible manufacturing scales with strong process understanding, we enable rapid transition from R&D to early development without the cost, rigidity, or timelines associated with full GMP manufacturing. Our approach supports mRNA, self-amplifying RNA, and related RNA modalities for therapeutic, gene editing, and immunization applications.

Service Highlights

  • Standardized manufacturing workflows aligned with GMP principles, without full GMP operational overhead.
  • Designed to support advanced preclinical, toxicology, IIT and IND-enabling studies.
  • Manufacturing scales adapted to development and IIT/IND needs, enabling rapid material supply.
  • Grade C clean room environment with strong emphasis on impurity control, consistency, and batch-to-batch reproducibility.
  • Clear process documentation to support regulatory preparation and technology transfer.
  • Built to integrate smoothly with Crystal NAX’s RNA design, LNP formulation, and analytical platforms.

Our Promise

  • GMP-Like Process Design
  • Early-Phase Manufacturing Readiness
  • Flexible Scale & Fast Turnaround
  • High-Quality Output
  • Process Transparency & Documentation
  • Seamless R&D to Development Transition

When to choose GMP-Like?

image 2 Crystal Nucleic Acid X (CNAX) Early Phase Manufacturing
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