We advance subunit vaccine candidates within an integrated Pharmaceutical Development & Manufacturing framework that links upstream science to CMC rigor. Our program is anchored in Drug Substance Development and extends through fit-for-purpose formulation under Vaccine Development, ensuring coherent decisions across construct optimization, process definition, analytical control, and stability enablement.
Overview of Subunit Vaccine Development
Subunit vaccines present purified antigenic components—recombinant proteins, select peptides, virus-like particles (VLPs), or polysaccharide-protein conjugates—designed to focus the immune system on key epitopes while minimizing extraneous components. Their success depends on preserving epitope conformation, achieving consistent post-translational features, selecting compatible adjuvants, and maintaining stability across handling and storage. From a CDMO perspective, the center of gravity is robust CMC design: scalable expression platforms, high-resolution purification, orthogonal analytics, and formulations tuned for adsorption, release, and stress tolerance.
Our Services
We provide an end-to-end, development-focused CDMO suite. Programs are modular—each service can be engaged individually or sequenced as a coherent pathway.
Antigen Developability Engineering Service
We reshape antigen constructs for manufacturability while protecting functional epitopes. Activities include domain boundary refinement, signal peptide and tag strategies, glycosylation stewardship, liability scanning (e.g., deamidation, oxidation hotspots), and aggregation risk reduction.
Expression Platform & Upstream Process Development Service
We qualify expression systems matched to antigen class: CHO or HEK for complex glycoproteins, Pichia for secreted proteins with high space–time yield, and E. coli for peptides or fragments. Fed-batch or perfusion strategies are defined by DoE, linking feed profiles, redox balance, osmolality, and temperature shifts to titre, folding, and glycan patterns. Scaled-down bioreactors emulate shear and mass-transfer conditions to ensure translatability.
Analytical Method Development & Characterization Service
We build orthogonal, stability-indicating methods aligned to the modality: RP/SEC-HPLC and LC-MS peptide mapping, intact mass and glycan profiling, cIEF/CE-SDS for charge and size variants, DLS and TEM for nanoparticles, and ligand-binding/biophysical potency surrogates. Conjugates receive degree-of-conjugation and saccharide integrity assays; VLPs receive assembly and particle-count analytics.
Stability, Forced-Degradation & Comparability Service
Accelerated, stress, and long-term programs define degradation pathways and shelf-life projections. We create product-specific stability-indicating panels, trend critical quality attributes, and establish acceptance criteria. Comparability protocols de-risk sequence, process, or site changes, linking analytical similarity to prior knowledge and control strategies.
Specialized VLP & Conjugate Process Development Service
For VLPs, we optimize co-expression ratios, assembly conditions, and particle homogeneity. For polysaccharide–protein conjugates, we tune activation chemistries and conjugation parameters to achieve targeted coupling densities and size distributions while preserving antigenicity. Process descriptions include in-process analytics and release-relevant specifications.
Our Subunit Vaccine Development Portfolio
Our services support a portfolio of widely used subunit vaccine products. The following list illustrates common categories we can develop, including but not limited to these options:
- Recombinant protein antigens
- Peptide and multi-epitope vaccines
- VLPs
- …
- Detoxified protein toxoids
- Outer membrane vesicle–based preparations
- Polysaccharide–protein conjugates
We deliver development-centric, CMC-driven subunit vaccine programs that are designed to support informed decision-making and efficient progression from early research into advanced development. Our integrated capabilities span the full development continuum, from antigen design, developability assessment, and expression optimization to scalable purification processes, comprehensive analytical characterization, and robust stability strategies.
By leveraging a modular and flexible service model, we enable rapid iteration, clear stage-gating, and data-driven prioritization, helping teams minimize technical risk, reduce downstream rework, and conserve resources. Each program is tailored to align with regulatory expectations and long-term manufacturing needs, ensuring candidates are well prepared for seamless advancement into later-stage development and clinical manufacturing. Contact us to define a customized development pathway aligned with your scientific, technical, and strategic objectives.
Our products and services are for research use only.
