Creative Biogene | GMP 等級一站式 RNA CDMO 服務：簡化 RNA 療法開發的關鍵

Overview

As a pioneering force in nucleic acid-based therapeutics, Creative Biogene has spent years refining RNA CDMO services, with particular focus on mRNA, saRNA, and circRNA manufacturing and delivery technologies. We are dedicated to building a collaborative, open-access, and fully integrated CDMO platform designed to accelerate RNA therapy development from research to pre-clinical lab.

GMP-RNA One-Stop CDMO Service

Built upon international GMP standards and modular technical platforms, our CDMO offering encompasses the entire RNA therapeutic development chain—from plasmid production and mRNA synthesis to LNP encapsulation and aseptic filling. We support a wide variety of RNA formats, including linear mRNA, circRNA, and saRNA, facilitating seamless progression from preclinical R&D through clinical trials and into commercial manufacturing.

Modular CDMO Production Lines

Creative Biogene offers flexible RNA therapeutic production capabilities through three distinct manufacturing tracks: a standard production line, an expanded capacity line for clinical and commercial scale, and a rapid-response line tailored for personalized cancer vaccines. Each line supports plasmid, RNA, and LNP manufacturing with scalable, GMP-compliant processes optimized for speed, precision, and regulatory readiness.

Project Type

Standard Line

Expanded Line

Personalized Vaccine Line

Plasmid Yield

100 mg – 6 g

200 mg – 30 g

0.1 – 20 mg

Plasmid Process

High/Low-density fermentation + 2–3 step purification

High/Low-density fermentation + 2–3 step purification

Flask/Fermentation + 1–2 step purification

RNA Yield

0.1 – 10 g

1 – 100 g

10 mg – 2 g

RNA Process

Co-transcriptional or enzymatic capping + affinity purification

Co-transcriptional or enzymatic capping + affinity purification

Co-transcriptional capping + affinity purification

LNP Yield

0.5 – 10 g mRNA

2 – 100 g mRNA

10 – 500 mg mRNA

Fill-Finish

5,000 vials/batch (2–10 mL)

50,000 vials/batch (2–10 mL)

1,000 vials/batch (2–10 mL)

Applicable Stage

IND Filing & Phase I

Phase I–III & Commercial

IIT, IND Fast Track, Personalized Cancer Vaccine

Reliable

Scalable

Agile

Analytical Science & Quality Control

Creative Biogene provides comprehensive quality assurance and analytical support throughout the RNA manufacturing process. Our services encompass method development, verification, and technology transfer aligned with GMP standards, alongside thorough product characterization—covering biochemical, physicochemical, and biological properties—to ensure product consistency and stability.

Quality control is enforced through strict batch release testing, environmental monitoring, and accelerated as well as long-term stability studies. Our quality system integrates validated production environments, including HVAC and water systems, with a strong focus on contamination control and lifecycle stability management to guarantee product safety and regulatory compliance at every stage.

Lifecycle Coverage

We provide full-spectrum support across the drug development lifecycle, from GLP-grade material preparation for toxicology studies and IND/BLA submission support to GMP manufacturing for clinical and commercial stages. Our process includes seamless handoff between process development, analytical method validation, and aseptic fill-finish.

Accelerated Timelines

With a robustly optimized platform, we can complete GMP release of a full plasmid-mRNA-LNP CMC package in as little as 5 months, with simultaneous regulatory support for both US and EU filings.

A Team You Can Trust

We believe that only through full integration of design, manufacturing, and regulatory disciplines can we truly unlock the potential of RNA medicines. Creative Biogene is committed to being your most reliable and agile partner across this transformative journey.