Vaccines
Vaccines are among the most effective tools ever developed to protect public health. By teaching the immune system to recognise and respond to pathogens, they prevent the spread of infectious agents. This principle has enabled the eradication of several deadly diseases and has sharply reduced the global impact of many others. Today, vaccines are also being developed to address cancers and emerging infectious threats, reinforcing their role in protecting both individuals and entire communities.
Your partner in vaccine analytics
Ensuring that a vaccine is safe and effective requires rigorous analytical testing. Every step of production must meet strict regulatory standards, supported by reliable data on quality, safety and efficacy.
At Quality Assistance, we bring over 40 years of analytical expertise to support vaccine manufacturers. With our fully integrated, GxP-compliant technical and technological platforms, we deliver comprehensive analytical services including structural characterisation, content and purity assessment and potency testing. Our data provide the confidence needed for stability studies, batch release and regulatory approval, helping ensure that vaccines reach patients safely and in compliance with regulatory requirements.
Common tests across vaccine’s types
Across all vaccine types, our analytical solutions cover the key attributes required to demonstrate the quality and compliance of the vaccine candidate:
| Residual solvents | HS-GC (FID, MS) |
|---|---|
| Elemental impurities | ICP (OES, MS) |
| Residual salts | HPAEC (conductimetry) / ICP (OES, MS) |
| Residual proteins (including HCP, purification Ab) | ELISA / ECL (MSD) / Gyrolab / Luminex / UPLC (MS/MS) / 2D gel / 2D-DIGE |
| Residual DNA (bacterial chromosomal DNA, genomic DNA, plasmid DNA, Host Cell DNA) | qPCR / PicoGreen |
| Residual RNA | RiboGreen |
| Medium components (Tween, β-OG, FBS, antibiotics, cytokines, hormones, BSA, enzymes, growth factors, phenol red, insulin) | ELISA / ECL (MSD) / Colorimetry / (U)HPLC (UV, MS, Fluorescence, ELSD, CAD) / GC (FID, MS) / Luminex / Gyrolab |
| Chemicals agents (formaldehyde, beta-propiolactone) | (U)HPLC (UV, MS) / GC (FID, MS) |
| Residual benzonase / Trypsin / Tryp-LE / etc. | ELISA / Enzymatic assays |
| Process contaminants (CsCl, EtBr, iodixanol, alkaline detergent, acetate, PEG, sucrose, phenol) | (U)HPLC (MS) / CE / GC (MS) / ICP (MS) |
- ADJUVANTS (e.g. Al, Ca SALTS, MPLA, GLA, LIPOSOMES, LNP)
| Adjuvant assay / Characterisation | Automated titration / ICP (OES/MS) / GC (FID) / HPLC (ELSD, CAD) / DLS |
|---|---|
| Adsorption studies | To be discussed |
- NANO-DELIVERY SYSTEM
| Assay and impurities | Automated titration / ICP (OES/MS) / GC (FID) / HPLC (ELSD, CAD) |
|---|---|
| Size distribution | DLS / AF4 (UV, RI, MALS) |
| Surface charge / Zeta potential | Laser Doppler Micro-Electrophoresis (Zetasizer) |
- ANTIMICROBIAL (e.g. THIOMERSAL, 2-PHENOXYETHANOL, BENZETHONIUM CHLORIDE, PHENOL)
| Antimicrobial effectiveness testing | Plate count |
|---|---|
| Antimicrobial assay | (U)HPLC (UV, DAD, RI, fluorescence, ELSD, CAD, conductimetry, MS) |
| Immunogenicity / In vitro assay | To be discussed on a case-by-case basis |
|---|
| Container Closure System Integrity | Bubbling / Dye ingress / Microbial ingress |
|---|---|
| Leachables | GC (FID, ECD, MS) / ICP (OES, MS) / (U)HPLC (UV, ELSD, CAD, MS) |
| Cytotoxicity / Biological reactivity | Cell-based assays / USP <87> |
| Break Loose and Glide Force (BLGF) for prefilled syringes |
| Level of antibody production (GMT) | ELISA-based platforms |
|---|---|
| Release of other molecules that orient the immune response | Cell based assays (cytotoxicity, proliferative, cell death, cell migration, cell receptor binding and activation, reporter gene assays, etc. ) / ELISA / MSD / FACS / Luminex / SPR (Biacore) / BLI (Octet) |
We cover all major vaccine technologies
Why Choose Quality Assistance?
Partnering with us means working with a scientific extension of your team and a true strategic partner. Here is what set us apart:
- Proven expertise: 40+ years exclusively dedicated to pharmaceutical analytics, with over 2,000 drug candidates supported
- One site, one system: all laboratories and expertise centralised under one roof, eliminating inter-site delays and ensuring full data traceability
- Regulatory confidence: integration of both EMA and FDA expectations, combined with deep understanding of ICH requirements
- Full GxP environment: GMP, GLP, and GcLP/GCP compliance, providing data integrity and audit-readiness at every stage
- Customised strategies: analytical protocols designed to fit your vaccine project’s specific phase and regulatory context
With Quality Assistance, you gain more than a service provider, you gain a trusted scientific partner that secures every step of your project and accelerates its path to patients.
Learn more about Quality Assistance
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Ready to move your vaccine candidate forward?
Contact our experts today to discuss a tailored analytical strategy and ensure your vaccine programme advances with precision and compliance.