Health Protection Agency - Healthcare Product Research, Development and GMP Manufacture

The Health Protection Agency has been working with the pharmaceutical industry for over 50 years, undertaking contract research, development and manufacture of healthcare products. This includes expertise in vaccines, enzymes, therapeutic proteins and other biologically derived compounds.

The Health Protection Agency has a range of licensed facilities including both GMP and non-GMP areas for the development of biological products derived from microbial fermentation, particularly those requiring microbial containment or focused on the biodefence market.

Our services include GMP manufacture, biosafety level 2 and 3 containment, biodefence, providing clinical trial material, producing vaccines, overseeing process development and running GLP testing laboratories. The Health Protection Agency also remains dedicated to small-scale needs.

CUSTOM MANUFACTURING SERVICES

We are able to undertake the various stages of process development from initial concept through to finished product by working in partnership with our customers. These include:

• A proprietary expression system
• Cell banking
• Media development and yield optimisation
• Fermentation scale-up
• Purification and down stream processing
• Fill and finish capabilities

The initial development phase of a project is undertaken in our process development suite that was upgraded in 2004 by the installation of new fermenters. Pilot scale facilities for process development and scale-up include 50L and 250L bioreactors. Once a process has been optimised, we are able to offer a seamless transfer into our GMP manufacturing facilities.

GMP PRODUCTION PLANT FACILITIES

Our GMP production plant features bacterial fermentation vessels from 25L to 750L and product recovery equipment including continuous centrifuges and crossflow filtration equipment, enabling us to be flexible in response to your needs.

A separate licensed facility is designed to operate up to containment level 3 conditions with dedicated air handling and effluent treatment for the manufacture of specialist products, including toxin therapeutics and biodefence vaccines.

We will be upgrading our filling and freeze-drying suite during 2005. This will not only increase our filling capacity but also enable us to undertake specific contract filling operations for customers in the future.

RESEARCH, DEVELOPMENT AND TESTING SERVICES

Research is the driving force of the Health Protection Agency's centre at Porton Down, which is internationally recognised as a world leader in high quality microbiological research and testing. We have a proven track record of working with foreign governments, international biotechnology and pharmaceutical corporations, as well as start-up and spin-out companies.

Our areas of expertise include:

• Bacterial vaccines
• Toxin therapeutics
• GLP and in-vivo testing of compounds
• Biodefence and biosafety testing
• Diagnostics
• Provision of cell cultures

THE HEALTH PROTECTION AGENCY

The Health Protection Agency is a national organisation dedicated to protecting public health and reducing the impacts of infectious diseases, poisons, chemical and radiation hazards within the UK.

Business activities are primarily based at our Porton Down site, which was previously known as the Centre for Applied Microbiology & Research (CAMR). Our strategic goal is "to build on and develop the intellectual assets of the organisation in partnership with industry", and we aim to develop partnerships which offer benefits to both parties.