Analytical Development
State-of-the-art analytical techniques
Analytical method development
Developing a robust, scalable manufacturing process, and producing safe and effective vaccines that meet global regulatory requirements is a technical challenge. Our process development and cGMP manufacturing services help you every step of the way, from strain construction to preclinical assessment.
Analytical services & assays (click here for a complete list)
| Analytical assay | Assay objective | Execution under R&D | Execution under GMP |
|---|---|---|---|
| Biosensor Analysis | Detects real-time antibody-antigen interactions (affinity, concentration). | √ | ─ |
| ELISA - Serology | Quantifies antigen-specific antibody titers in serum. | √ | ─ |
| ELISpot | Measures antigen-specific B or T cell frequency. | √ | ─ |
| HA Inhibition Test | Detects antibodies that inhibit virus-induced hemagglutination. | √ | ─ |
| Multiplex Immunoassay (Serology) | Simultaneously quantifies multiple antigen-specific antibody titers. | √ | ─ |
| Serum Bactericidal Assay | Determines antibody titers mediating complement-dependent bacterial killing. | √ | ─ |
| VNT Assay | Measures virus-neutralizing antibody titers. | √ | ─ |
| Western Blotting | Detects antigen-specific antibodies in protein samples. | √ | ─ |
| Benzonase Activity | Measures enzymatic degradation of nucleic acids. | √ | √ |
| Circular Dichroism (CD) | Determines secondary and tertiary protein structure. | √ | ─ |
| Dynamic Light Scattering (DLS) | Measures particle size distribution in solution. | √ | √ |
| Electrophoretic Light Scattering (ELS) | Determines zeta potential of particles in solution. | √ | √ |
| ELISA - Antigen | Detects and quantifies antigens. | √ | √ |
| FFF-MALS | Analyzes particle size, molar mass, and aggregation. | √ | ─ |
| Fluorescence Spectroscopy | Assesses protein tertiary structure and conformational changes. | √ | ─ |
| Micro-Flow Imaging (MFI) | Detects and characterizes sub-visible particles. | √ | √ |
| Protein Concentration Determination | Measures protein concentration in a sample. | √ | √ |
| qPCR | Quantifies DNA/RNA for viral load and contamination. | √ | √ |
| TCID50 | Determines infectious virus titer in cell culture. | √ | √ |
| SDS-PAGE | Assesses protein size and purity. | √ | ─ |
| DSC | Assesses thermal stability and melting properties. | √ | ─ |
| GC | Quantifies lipids (e.g., LPS, phospholipids). | √ | √ |
| HPAEC-PAD | Quantifies carbohydrates and glycans. | √ | √ |
| HP-SEC | Analyzes protein purity, aggregation, and degradation. | √ | ─ |
| Karl Fischer Titration | Measures water content in formulations. | √ | ─ |
| LC-MS | Identifies and quantifies antigens, impurities, and metabolites. | √ | √ |
| NMR | Determines chemical structure and purity. | √ | √ |
| Study Type | Application | Execution under R&D | Execution under GMP |
|---|---|---|---|
| Formulation feasibility | Assesses drug product stability in 1–3 predefined formulations. | √ | ─ |
| Characterization and assay selection for formulation studies | Verifies assay suitability to detect product instability before formulation screening. | √ | ─ |
| Formulation screening (plate based) | Screens excipient combinations to identify promising stabilizing agents. | √ | ─ |
| Formulation optimization | Optimizes formulation using Design of Experiments (DoE) with multiple excipients and conditions. | √ | ─ |
| Development Stability Studies | Evaluates stability under real-time/accelerated conditions for shelf-life modeling. | √ | ─ |
| Device Compatibility Testing | Assesses compatibility and performance with administration devices. | √ | ─ |
| In-Use Stability Study (Pharmacy manual qualification) | Tests drug product stability during clinical preparation and use. | √ | ─ |
| Freeze Drying (Lyophilization) Tech transfer | Transfers lyophilization cycle to internal lab for execution. | √ | ─ |
| Freeze Drying (Lyophilization) Cycle development | Develops an initial lyophilization cycle for the product. | √ | ─ |
| Freeze Drying (Lyophilization) Cycle optimization | Optimizes lyophilization parameters for robustness and efficiency. | √ | ─ |
| Freeze Drying (Lyophilization) Formulation screening study (plate based) | Screens excipients for stability in lyophilized formulations. | √ | ─ |
| Freeze Drying (Lyophilization) Formulation optimization | Optimizes lyophilized formulation and cycle parameters. | √ | ─ |
| Freeze Drying (Lyophilization) Development stability studies | Assesses stability of lyophilized product under various conditions. | √ | ─ |
| Study Type | Application | Delivered services |
|---|---|---|
| Immunogenicity Studies | Evaluates immune responses (e.g., titers, VNT, SBA) to vaccine in animals. | Outsourcing to external partner (including ethical approval) |
| Adjuvant Evaluation Studies | Assesses safety and immune-enhancing effects of adjuvants in formulations. | Outsourcing to external partner (including ethical approval) In-life phase Humoral immunity (IgG, functional assay) Reporting |
| Dose Ranging/Finding Studies | Identifies optimal dose range for efficacy and safety in animal models. | Outsourcing to external partner (including ethical approval) In-life phase Humoral immunity (IgG, functional assay) Reporting |
| Toxicology Studies | Determines toxic effects, safety margins, and suitable dosing levels in animals. | Outsourcing to external partner In-life phase Serology testing (functional readout) Reporting |
State-of-the-art equipment
With state-of-the-art instruments, such as LC-MS, NMR, HPLC and GC systems, biosensor and qPCR instruments at their disposal, our experienced staff develop analytical methods for existing and newly developed vaccines. We perform method development, including GMP-compliant method validation, stability studies, and consistency in production.
Antigen characterization
QC includes support in the development and validation of product specific analytical techniques at the highest standards of quality. Validation of assays is performed according current IHC Q2 (R2) guidelines.
Immune response characterization
We carefully characterize the immunological response to a vaccine by examining humoral and cellular responses in samples from pre-clinical experiments. We focus on assays for T cell activation and use virus neutralization tests and serum bactericidal assays to determine neutralizing antibodies.
What can you expect from our analytical services?
- GDevP and GMP method development to define quality attributes (QAs) and critical process parameters (CPPs)
- Analysis of viral (inactivated and live-attenuated), bacterial (toxoids, whole-cell, and OMV), subunit, and conjugate vaccines
- Rapid identification and quantification of vaccine products and process impurities
- First-in-class mass spectrometry
- Extensive spectroscopic and chromatographic tools
- Complete immune and biochemical toolbox
Test development
Every aspect relevant to the efficacy and safety of a vaccine must be meticulously evaluated with fit-for-purpose assays. We develop tests to detect impurities, such as lipopolysaccharides, host cell DNA and proteins, and to assess product yield and the presence of excipients and adjuvants.
Assay development and validation
Choosing the right assays to determine manufacturing consistency and product parameters are essential to the quality, potency, and safety specifications of a vaccine. Intravacc has a proven track record in establishing validated quality control methods according to ICH guidelines. We provide all aspects of assay development and validation and method transfer. Furthermore, when part of a GMP campaign, the assays can support an IMPD filing.