We advance vaccine programs within a rigorous Pharmaceutical Development & Manufacturing framework and its child domain, Drug Substance Development. Our teams align sequence design, process engineering, and analytical science from the outset to establish robust, inspection-ready foundations for inactivated, subunit, and DNA/RNA modalities.
Overview of Vaccine Development
Vaccine development in regulated settings hinges on early, data-driven definition of critical quality attributes (CQAs)—identity, potency, purity, safety, and consistency—mapped to modality-specific risks. Inactivated platforms require controlled inactivation with preserved antigenic features and verified clearance of residual reagents. Subunit approaches prioritize manufacturability of recombinant antigens with stable tertiary/quaternary structures and, where relevant, consistent post-translational profiles. DNA and RNA platforms center on template architecture, in vitro transcription (IVT) or plasmid production, and, for RNA, rational delivery systems. Across modalities, we deploy quality by design (QbD), platform analytics, and comparability protocols to support efficient iteration (e.g., sequence or strain updates) without resetting development.
Our Services
Our work concentrates on process and analytical design, risk-based characterization, and stability strategies. Representative deliverables include modality-specific platform processes, orthogonal analytical methods with phase-appropriate validation, comparability packages, and stability-indicating profiles.
Inactivated Vaccine Development Service
We engineer inactivated vaccine processes to protect antigenic integrity while establishing rigorous control of inactivation and impurity profiles. Beginning with qualified upstream materials, we screen inactivation chemistries and thermal paradigms at development scale, using design-space exploration to understand the relationship between exposure parameters and structural preservation. Orthogonal antigenicity assays (e.g., binding surrogates aligned to function) are paired with particle-level readouts to confirm that key epitopes and size distributions remain within predefined limits. We implement sensitive quantification for residual inactivation reagents and by-products and design clearance strategies in downstream unit operations. Our analytical suite addresses host-cell impurities, nucleic acids, and adventitious profiles with phase-appropriate depth. Robustness, precision, and reportable ranges are established for release-enabling methods, and we construct stability protocols to stress relevant degradation pathways.
Subunit Vaccine Development Service
We develop recombinant protein or polysaccharide subunit antigens with manufacturability at the core. Expression system selection (mammalian, yeast, bacterial) is guided by sequence liabilities, folding requirements, and desired post-translational features. We design purification trains using platform capture with orthogonal polishing to achieve high purity, low aggregation, and predictable charge or glycan signatures. Early developability screens evaluate conformational stability, surface hydrophobicity, and excipient compatibility to inform formulation concepts. For glycoprotein antigens, we characterize glycan occupancy and distribution and establish acceptable variability bands linked to potency readouts. Our analytics encompass identity (mass spectrometric fingerprints), size/charge heterogeneity, residual DNA/proteins, and potency surrogates—harmonized to stability-indicating methods for real-time trending. We prepare comparability frameworks that support sequence refinements, host changes, or scale transitions while preserving CQA intent and historical data continuity.
DNA/RNA Vaccine Development Service
For plasmid DNA and RNA modalities, we focus on template design, process scalability, and delivery-aligned quality attributes. Plasmid DNA workstreams include backbone optimization, isoform control, impurity reduction, and high-fidelity release analytics. For mRNA, we establish IVT systems with controlled template architecture (5′ UTR/cap structure, coding region, 3′ UTR, poly(A) design) and deploy purification trains that reduce double-stranded RNA and process-related residues. We define CQA panels for nucleic acids—integrity, capping or supercoiled content, sequence confirmation, residuals, and potency surrogates—along with stability models tailored to hydrolytic and oxidative sensitivities. When delivery via lipid nanoparticles (LNP) is planned, we design a development path that characterizes encapsulation, particle attributes, and release-relevant performance metrics without divulging proprietary compositions. Analytical orthogonality and method robustness are emphasized to ensure traceable, reproducible results across development lots.
We deliver vaccine CMC programs with platform strength, analytical depth, and clear comparability logic. Whether inactivated, subunit, or DNA/RNA, our development solutions are purpose-built for regulated progression. Contact us to tailor a scope aligned to your timelines and evidence needs.
Frequently Asked Questions
Q1: What constitutes a robust potency approach for subunit antigens?
We pair a primary, mechanism-relevant binding or activity surrogate with confirmatory analytics that track structural integrity and aggregation. Potency acceptance criteria are anchored to CQAs and stability behavior, enabling meaningful lot-to-lot trending and scientifically defensible comparability when upgrading sequence, host, or scale.
Q2: Which CQAs are most critical for mRNA, and how are they controlled?
Key CQAs typically include sequence integrity, correct 5' cap and poly(A) features, low double-stranded RNA, controlled residuals, and predictable delivery performance when encapsulated. We implement orthogonal measurements for each, design stress studies to reveal degradation pathways, and establish acceptance ranges tied to release and stability-indicating methods.
Q3: How is glycosylation handled for protein subunits that require specific profiles?
We use host selection, media levers, and polishing orthogonality to guide glycan distributions into acceptable bands, then confirm with high-resolution mapping. Potency surrogates and charge/size analytics are aligned so that glycan variability is scientifically justified and operationally controllable under a documented comparability framework.
Our products and services are for research use only.
