Science-driven, quality-first, submission-oriented, and efficient in translation. With an engineering mindset, RNACure builds standardized, repeatable process development and quality control strategies that deliver end-to-end CMC support for mRNA medicines from bench to clinic.
End-to-end process development and quality control for mRNA medicines from sequence to finished product. Every module follows QbD principles to ensure robust, controllable, and reproducibly scalable processes.
From template design to transcription optimization, we establish efficient, well-controlled in vitro mRNA synthesis processes that scale reliably from microgram to gram quantities.
Leveraging unit operations such as chromatography and ultrafiltration, we build a high-recovery, high-purity mRNA purification platform that removes impurities and ensures product consistency.
A proprietary lipid library and high-throughput screening platform optimize delivery systems for different targets and indications, achieving efficient encapsulation and stable formulations.
A comprehensive analytical suite covering mRNA drug substance and drug product, including purity, integrity, capping rate, poly(A) tail, LNP particle size, and other critical quality attributes.
ICH-aligned long-term, accelerated, and freeze-thaw stability studies for drug substance and drug product, providing data to support storage conditions and shelf-life prediction.
Seamless scale-up from laboratory to GMP manufacturing, supported by thorough process characterization and validation to ensure multi-batch consistency and transferability.
Grounded in regulatory science, we embed Quality by Design (QbD) throughout the CMC lifecycle so every process decision is evidence-based.
Data-driven decisions and statistical methods guide process development and optimization, keeping every critical quality attribute controllable and predictable.
Quality is designed in, not inspected in. Quality considerations are introduced from the molecular design stage onward, building an end-to-end quality defense.
Aligned with FDA, EMA, and NMPA requirements, regulatory expectations are embedded into technical development up front to accelerate IND filing and clinical progression.
From defining quality targets to continuous improvement, we build a verifiable, repeatable, and continuously evolving process quality system.
Define critical quality attributes (CQAs) and establish a quantifiable quality target product profile (QTPP).
Identify critical process parameters (CPPs) through risk assessment and optimize the process space with DoE experiments.
Systematically study the causal relationship between process parameters and product quality to establish a design space and control strategy.
Complete process performance qualification (PPQ) under GMP conditions to confirm process robustness and reproducibility.
Continuously refine the process using production data and quality feedback, achieving quality management across the full lifecycle.
RNACure supports sample supply at every stage from early research to IND filing, with complete process and quality documentation at each milestone.
Milligram-scale mRNA synthesis and early formulation to support proof of concept and candidate screening
Establish analytical methods, optimize process parameters, and define critical quality attributes
Scale from laboratory to pilot scale, validating process robustness and reproducibility
GMP production of IND-enabling clinical samples with complete quality documentation
Comprehensive CMC dossier preparation supporting China-US dual filing for faster clinical advancement
A closer look at RNACure’s specific capabilities in LNP formulation development and analytical methods.
