We provide an integrated DNA/RNA vaccine development capability spanning Pharmaceutical Development & Manufacturing, Drug Substance Development, and Vaccine Development. Our teams translate nucleic-acid concepts into robust, well-characterized drug substances, with a disciplined quality and risk framework that supports reliable scale-up when required.
Overview of DNA/RNA Vaccine Development
DNA and RNA vaccine platforms rely on nucleic acids encoding target antigens that are produced in vivo after administration. Core development considerations include sequence architecture (coding region, UTRs, signal peptides), manufacturability of the template for plasmid dna vaccines (pDNA) or in vitro transcription (IVT), and delivery systems that protect and transport the payload to the appropriate cells. For plasmid DNA, supercoiled topology, low impurities, and propagation stability in microbial hosts are central. For mRNA and self-amplifying RNA (saRNA), in vitro transcription chemistry, capping, tailing, removal of by-products, and formulation quality determine performance. Analytical strategy must verify identity, purity, potency, and critical quality attributes across the drug substance and final presentation. We deliver these elements with a CDMO mindset focused on practical, phase-appropriate rigor.
Our Services
We offer end-to-end CDMO services organized under pharmaceutical development & manufacturing, drug substance development, and vaccine development. Programs typically combine nucleic-acid drug-substance development (pDNA or RNA), lipid nanoparticles (LNPs) formulation development, analytical method creation and qualification, and encoded-antigen characterization to de-risk performance.
Plasmid DNA Drug Substance Development Service
We design and develop robust plasmid DNA drug substances built for reliable propagation and downstream purification. Our work includes vector architecture review for manufacturability, host-strain and process scouting at bench scale, and purification route development to enrich the desired topology while reducing residual host-cell components. We create and qualify phase-appropriate analytical methods—such as assays for topology distribution, residuals, and identity—to support release and comparability. Early risk assessment maps critical material attributes to process levers, informing a control strategy that scales predictably.
mRNA / saRNA Drug Substance Development Service
For non-replicating mRNA and self-amplifying RNA, we optimize IVT chemistry, template strategy, and post-transcriptional operations to achieve high integrity and functional quality. Our teams evaluate sequence features affecting transcriptional efficiency and translation, establish purification approaches that reduce by-products, and develop capping/tailing strategies appropriate to program goals. Method development covers integrity, size distribution, residuals, and biologic activity via in vitro expression systems. The result is a robust, documented process and analytical package that supports later intensification when desired.
LNP Formulation Development Service
We develop lipid-based formulations that balance protection, delivery, and manufacturability. Using structured design-of-experiments, we explore composition space, payload-to-lipid ratios, and process parameters to manage size, polydispersity, and encapsulation efficiency. We tailor buffers, cryo-protectants, and handling conditions to minimize degradation and leakage under stress.
Analytical Development & Characterization Service
We build phase-appropriate analytical suites that track identity, purity, potency, and safety-related attributes across pDNA, RNA, and formulated presentations. Techniques encompass nucleic-acid integrity profiling, impurity and residual assessment, particle characterization for nanoparticle formulations, and in vitro expression-based potency readouts. We align method lifecycle activities—feasibility, optimization, qualification/validation—as program needs evolve, and convert data into clear specifications and acceptance criteria. Reference standards and trending plans support ongoing control and comparability across batches and sites.
Encoded-Antigen Developability & Reference Protein Service
Although nucleic acids are the primary actives, the expressed antigen ultimately drives biological performance. We perform in vitro expression of the encoded antigen to assess basic biophysical traits relevant to in vivo expression—such as solubility tendencies and post-translational features for secreted products. We also generate recombinant reference proteins and critical reagents to calibrate potency and immunoassays, ensuring analytical traceability. This service de-risks sequence choices without engaging in discovery, and feeds back into nucleic-acid and formulation design.
Process Scale-Down Modeling & DoE Strategy Service
We construct predictive, small-scale models for pDNA production, IVT, and formulation unit operations. By structuring multifactor studies, we identify sensitive parameters and define a resilient design space. These activities support material planning, specification setting, and future scale-up decisions while keeping experimentation efficient and informative. Deliverables include DoE reports, risk registers, and control recommendations aligned with quality-by-design principles.
Our DNA/RNA Vaccine Development Portfolio
We support mainstream nucleic-acid vaccine categories and their standard delivery formats. We provide, including but not limited to, development services for the following:
- pDNA: Supercoiled plasmid drug substances.
- Non-Replicating mRNA Vaccines: Capped, polyadenylated mRNA with tailored sequence architecture.
- saRNA Vaccines: Replicon-based RNA constructs with streamlined IVT and purification strategies.
We translate DNA/RNA vaccine concepts into well-characterized drug substances and formulations, backed by rigorous analytics and encoded-antigen support. Our CDMO teams integrate science with practical control strategies. Contact us to structure a fit-for-purpose program.
Our products and services are for research use only.
