RNA-based Therapy Product Development

As a specialized CDMO, we deliver integrated RNA programs under Pharmaceutical Development & Manufacturing and its child page, Drug Substance Development. We focus on phase-appropriate RNA drug-substance strategies that convert concept into manufacturable, well-characterized materials aligned with rigorous control.

Overview of RNA-Based Therapy Product Development

RNA platforms include coding formats (mRNA, self-amplifying RNA, circular RNA) and non-coding formats (siRNA, miRNA mimics/inhibitors, antisense oligonucleotides, aptamers). While architectures differ, development success depends on sequence designs that support manufacturability, impurity control, orthogonal analytics, stability, and compatibility with intended presentation. Our team harmonizes template generation, IVT paradigms or alternative syntheses, post-transcriptional conversions, purification logic, and conjugation interfaces, all under traceable raw-material governance.

Our Services

We provide two primary services: coding rna therapeutics development service and non-coding rna therapeutics development service. Supporting capabilities, including process and analytical method development, raw-material strategy and qualification, drug substance (DS)-level formulation and stability, and phase-appropriate CMC authoring, are embedded across both services to ensure manufacturable, well-controlled drug substances with transparent documentation.

Coding RNA Therapeutics Development Service

Non-Coding RNA Therapeutics Development Service

We align RNA modality with manufacturable drug-substance strategies, embed orthogonal analytics, and deliver coherent CMC packages. Our focused coding and non-coding RNA services provide rigorous, phase-appropriate development within a unified pharmaceutical development & manufacturing framework. Connect with us to shape a tailored program plan.

Frequently Asked Questions

Q1. How do you minimize double-stranded RNA and other process-related impurities in coding RNA drug substances?

We combine sequence-informed template design, IVT architecture tuned to reduce off-pathway species, and multi-modal purification. Orthogonal analytics—chromatographic, capillary, and targeted immuno-assays where suitable—quantify dsRNA, short fragments, residual DNA, enzymes, and inorganic residues to support specification setting and trending.

Q2. What is your approach to cap structure control and verification for mRNA?

We select co- or post-transcriptional strategies aligned with the target cap and process risk profile. Method suites assess cap identity and occupancy alongside integrity and length distribution, using orthogonal techniques so results remain interpretable across lots and phases.

Q3. How do you ensure conjugation readiness for siRNA/ASO drug substances without entering drug-product scope?

We define DS interfaces—protected handles, linker logic, and coupling order—then demonstrate cleanup and absence of reactive residues that could trigger side reactions. This preserves DS quality while enabling later attachment steps in downstream operations.

Our products and services are for research use only.