The ViVax Toolkit™
Our specifically designed range of biophysical techniques that give you the ability to fully characterise your vaccine.
ViVax: A toolkit for characterization of and comparability of vaccines.
Vaccines are designed to present foreign antigens to the immune system in a way that elicits a strong and lasting immune response. In order to do this the antigen is often presented in a form that is non-covalently bound to an adjuvant, such as aluminium hydroxide, used to prime the immune system so a relatively small amount of protein or virus can be used (ideal when there is the possibility of needing a vast amount of doses - as would be the case if there was an outbreak of pandemic flu arising from the H5 N1 strain of avian flu).
Apart from whole virus and viral antigen vaccines, developments such as Cancer vaccines have a massive potential both in saving lives and revenue generation for the companies that can get them to the market, with the potential for the cancer vaccine market to grow from an estimated $481 million in 2007 to more than $8 billion by 2012 according to market research firm Kalorama Information. Antigen specific cancer vaccines dominate all phases of development due to their relatively high specificity, ease of manufacture, opportunity for repeated administration and low level of safety concerns in comparison to cell based vaccines, although their manufacture and formulation involves significant complexity as reported by Datamonitor. Merck's cervical cancer vaccine Gardasil was approved by the FDA in June 2006 with analysts predicting sales of up to $4 billion per year assuming state governments mandate inoculation.
To get market authorisation involves not least providing proof to regulators that the product is both stable during its storage lifetime and has the efficacy intended as shown in the early development of the vaccine. Structural analysis and formulation development is increasingly important in this development. Adsorption to adjuvants can alter the structure of proteins and expose domains that were previously hidden therefore altering the efficacy of the native proteins whether whole virus or single proteins.
The ViVax toolkitTM has been developed to enable a reference fingerprint of the structure of the native protein prior to formulation and adsorption to an adjuvant. It is then possible to compare the higher order structure at each stage of development, including adsorption to the adjuvant if present, and make sure that there will be no critical issues, this analysis then can be used to develop an appropriate formulation which makes the protein stable under the desired storage conditions and time span using accelerated and thermal stability studies. Further characterization and comparability can be measured on a batch to batch basis allowing rapid identification of potential problems with individual batches that do not correspond to the reference fingerprint expected.
Combining the use of biophysical analysis techniques as developed in the Biophysical toolkit®, such as;
- Circular Dichroism
- Analytical UltraCentrifugation (Velocity and Sedimentation)
- Isothermal Titration Calorimetry,
- Differential Scanning Calorimetry
- Steady State Front Face Fluorescence (including custom built rotating stage)
- Fourier Transform Infa-red spectroscopy
- Raman spectroscopy
- UV Raman spectroscopy
- UV-Vis absorption spectroscopy
- Dynamic Light Scattering (including custom built in-house hydrodynamic column)
In combination with specialist microscopy techniques such as;
- Scanning Electron Microscopy
- Transmission Electron Microscopy
- Atomic Force Microscopy
This allows us to obtain critical information about the state of a vaccine such as aggregation, homo or heterogenicity, binding affinity and binding capacity to an adjuvant, providing a more complete molecular and structural characterization which can be correlated to the immunogenicity of the vaccine and a move towards the "well characterized molecule" as stated by the FDA as well as removing some of the problems faced by routine protein and ELISA assays when an adjuvant is involved.
Applications of the toolkit include;
- Native molecule characterization
- Understanding the effects of processes and process changes
- Investigations of aggregation
- Formulation development
- Comparability studies
- General higher order structural characterization and conformational information
It isn't just the range of biophysical analysis techniques, not offered by other more routine contract organizations, but also the experts that understand them in one organization. These experts not only know the techniques and instruments, but, more importantly, understand that you need more than just raw data. Avacta will provide you with a new, deeper and more accurate insight into your vaccines' structure and behavior.
Better characterisation and the regulatory bodies
All the techniques have been developed with ICH guidelines in mind, and with the FDA championing fuller characterisation of therapeutic protein structures, it is safe to assume such techniques, in the future, will be required for all regulatory work. Get ahead of the regulators, and your competitors, by making complete biophysical characterisation of your vaccines routine in your company.
Commitment to quality
Avacta is ISO 9001:2000 registered and is committed to the highest scientific standards. Thoroughness, accuracy and integrity are the foundations of all its research and analytical work and are second nature to its highly qualified staff
Register and download our free biophysical techniques guides.
For more information on how the ViVax services we offer can help you, please contact us on +44 (0) 870 835 4367 or