Recombinant protein vaccines
Recombinant protein vaccines are among the most established and widely used modern vaccine technologies, with approved products offering protection against diseases like zoster, meningitis, hepatitis B and human papillomavirus (HPV). Produced in mammalian cells, bacterial or yeast, they provide a safe and effective alternative to vaccines based on live or inactivated pathogens.
Your partner for recombinant protein vaccines
The excellent safety profile and strong immunogenicity of these vaccines, when combined with formulation adjuvants, make them attractive approaches not only for infectious diseases but also for emerging applications in oncology and chronic conditions. Their biological origin, however, creates significant analytical challenges.
These vaccines require in-depth characterisation to confirm identity and post-translational modifications (including glycosylation), while variability in folding, purity, antigenicity and potency must be carefully monitored and controlled. Product and process-related impurities such as residual host cell proteins (HCPs) and DNA also demand sensitive and compliant analytical strategies that integrate chemical and biological expertise.
Our G(C)LP-compliant bioanalytical services cover the full development continuum, from non-clinical to clinical phases to enable the characterisation of the immune response, including biomarker analysis with multiplexed immunoassays.
At Quality Assistance, we provide the regulatory-ready data required to demonstrate the safety, quality and efficacy of recombinant protein vaccines, supporting your project from research to market approval and beyond.
Specific analytical services for recombinant protein vaccines
To meet the requirements of your recombinant protein vaccine, we apply a wide range of analytical techniques throughout its entire development lifecycle. From early-stage development to final batch release, our assays are designed to provide the reliable, decision-enabling data you need. Our comprehensive set of analytical services include:
| Mass distribution profile | MS (ESI-QTOF / MALDI-TOF) |
|---|---|
| Structural integrity | CD / FT-IR |
| Isoforms | icIEF / (U)HPLC (IEX, RP, SEC, HIC) / 2D gel / Peptide mapping / MS |
| Aggregation / Fragments / Particle size distribution | SEC-(U)HPLC (UV, RI, MALS) / AF4 / cGE / DLS / SDS-PAGE / Imaging Particle Analysis |
| Glycosylation patterns | UPLC (FLUO, ESI-QTOF) / MALDI-TOF / CE (LIF) / GC (MS) |
| Disulphide bridges | Peptide mapping (UPLC-UV/MS) / cGE / SDS-PAGE |
| Free thiols | Fluorescence (NPM) / UV (Ellman, DTNB) |
| Degradation patterns (including Met oxidation / Asn deamidation) | IEX / RP-(U)HPLC / SE-(U)HPLC / SDS-PAGE / (U)HPLC (MS) / CE (icIEF, cGE) / 2D gel |
| Protein quantity | BCA / Lowry / Bradford / UV / (U)HPLC (UV, Fluo) |
|---|---|
| Absolute protein content determination | ICP-MS (S, isotope dilution) |
| Determination of extinction coefficient | UV + ICP-MS (S, isotope dilution) / UV |
| Immunoassays / Antigenicity | ELISA / ECL (MSD) / Immunodiffusion (RID) / Luminex / SPR (Biacore) / BLI (Octet) / FACS |
We cover all major vaccine technologies
Integrated services for vaccines
While we provide in-depth analytical support for recombinant protein vaccines, our expertise goes beyond this specific subject. We offer a full spectrum of analytical services that are essential for the development of all vaccine types.
For a complete overview of our wide-ranging capabilities, including services applicable to all vaccine platforms:
Related services
Beyond vaccines
The analytical expertise developed for recombinant protein vaccines is also applied to protein therapeutics such as monoclonal antibodies and other recombinant proteins. This continuity ensures consistent, compliant support across your entire biotherapeutics pipeline.
Ready to move forward ?
Developing recombinant protein vaccines demands precision, regulatory expertise, and robust analytical solutions. At Quality Assistance, we bring these together to provide the clarity and compliance you need to move forward with confidence.
Talk to our experts today to accelerate your recombinant protein vaccine project.