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Vaccine Evaluation Services

Vaccine Evaluation

We offer a wide range of services from the development of assays right through to work to support vaccine clinical trials.

The development of effective new vaccines is dependent upon the body being able to generate immune responses to the components of the vaccine that will confer protection against the infectious agents. The quantitative and qualitative measurement of such responses is part of a comprehensive package of services that the Agency is able to offer to government, academia and industry.

We offer a wide range of services from the development of assays right through to work to support vaccine clinical trials.

Assay Development

We are able to undertake the development of new assays. Working in conjunction with the customer we can utilise our experience and scientific knowledge in developing assays to meet customer requirements.

This work includes the typical stages in assay development through to validation.

  • Optimisation of assay conditions
  • Assay range
  • Specificity
  • Precision

 

Assay Validation  

Validation of analytical methods is crucial in generating data in support of regulatory submissions. HPA can offer assay validation which is suitable for the clinical development of vaccines. This includes:

  • Precision
  • Linearity
  • Limit of detection (LOD)
  • Limit of quantitation (LOQ)
  • Specificity
  • Accuracy
  • Robustness
  • System suitability

  • Stability

Clinical Trial Services

The provision a quality serological analytical service for the measurement of immune responses, including for example reactogenicity, immunogenicity, interference and induction of immunological memory to vaccine candidates is part of the service which we offer for products are undergoing clinical trials.

We have a number of facilities that are able to undertake evaluations, including the testing of clinical sera for a range of antigens as well as measurement of immunoglobulin responses to and reactivity of trial vaccines.

The provision of study nurses for the administration of and research into trial vaccines within a clinical unit is another one of the Agency's services.

Organisms / Diseases

Tubes

The Agency has a wealth of experience of working on a wide range of diseases and the agents which cause them, including : Anthrax, Botulism, Chlamydia, Haemophilus Influenzae type B, Human Metapneumovirus, Human Papillomavirus, Influenza, Measles, Meningitis B&C, Mumps, Polio, Rubella, Respiratory Syncytial Virus, Tuberculosis, West Nile Virus and Yellow Fever. The ability to work on such a range of diseases along with the experience that the Agency has in handling pathogenic agents, up to and including biosafety level 3, means that we are in an ideal position to assist with the development of vaccines to what may be considered exotic diseases or even potential bioterrorism agents.

As part of its routine surveillance work the Agency identifies the specific serotypes of disease causing agents that are currently circulating within the UK . We also have strong collaborative links to similar organisations in other parts of the world. This expertise could be of value in the selection and development of the most appropriate vaccine.

Delivering Quality

Our different units are accredited to various quality systems (including CPA, GLP or GCP) appropriate to the work they undertake which means that our customers can have confidence in the services we provide.

Our Track Record

We have a proven track record of assisting with the introduction of a range of new vaccines, particularly in the UK . This is because we have worked with the majority of the top pharmaceutical and biotechnology companies involved in the vaccine field for many years.

In addition the Agency has undertaken work for various research charities, national governments and NGO's at all stages of product development.

Besides research, product development and work on clinical trials, we are also able to undertake independent assessment and release testing of manufactured product for market. This service is currently undertaken for one of the top international vaccine companies.

We believe in establishing a genuine close working relationship with our customers and partners, to enable us to offer a bespoke service. Therefore please contact our business development team to discuss your requirements and how we can help turn your ideas into reality.