Intravacc Expands Integrated Analytical Services to Reduce CMC Risk in Vaccine and Biologics Development

For biologics developers navigating IND-enabling studies and early CMC package construction, Intravacc is positioning its integrated analytical platform as a direct lever for reducing regulatory risk. The Bilthoven-based CDMO announced an expanded commercial focus on analytical services spanning product characterization, assay validation, formulation support, and GMP campaign readiness on 8 June 2026.

The analytical offering covers identity, content, purity, structure, formulation, and stability assessment, applying methods including LC-MS, HPLC, biosensor analysis, qPCR, ELISA, and cell-based assays. Structural characterization extends to primary, secondary, and tertiary structure determination, post-translational modification identification, antigen binding affinity measurement, and thermal stability profiling, data sets that directly inform critical quality attribute definition under ICH Q8 and Q11 frameworks.

Formulation and stability work includes excipient and buffer screening, adjuvant and container compatibility studies, and real-time or accelerated stability programmes. For QA and regulatory leads, the practical consequence is that formulation decisions can be anchored in characterization data before process lock, reducing late-stage reformulation risk.

When analytical development runs inside a GMP campaign, Intravacc's validated methods can support clinical trial material release and IMPD-enabling documentation, a workflow integration that compresses the handoff between development and regulatory submission. Managing Director Ivo Lemmens noted that the model is designed to help partners define critical quality attributes, strengthen CMC packages, and move candidates to the clinic faster, without attributing specific timelines or approval outcomes.

Capabilities are available as stand-alone analytical services or embedded within broader CDMO programmes covering process development, technology transfer, formulation, and cGMP manufacturing through Phase I/II clinical production. The platform is applicable across viral, bacterial, subunit, conjugate, protein-based, and therapeutic vaccine modalities.

The degree to which this integrated model shortens IND timelines will become measurable as partner programmes advance through regulatory submission and first-in-human milestones.

Source: Intravacc via GlobeNewswire, 8 June 2026.