Public Health England’s(PHE) mission is to protect and improve the nation’s health and to address inequalities through working with national and local government, the NHS, industry and the voluntary and community sector. PHE is an operationally autonomous executive agency of the Department of Health that was formed in 2013 by amalgamation of a number of public sector bodies including the former Health Protection Agency .
The Development and Production (D&P) Department of PHE has been working with the pharmaceutical, biotechnology and healthcare sectors of industry for over 50 years undertaking contract research, development & production of products. We have particular expertise in taking concepts from the research laboratory and progressing them through the various stages of scale up and process development to the production of clinical grade material suitable for clinical trial. This includes both native and recombinant therapeutic proteins and the development of vaccines, particular those targeted at the biodefence area.
Our Process and Analytical Development Group (PADG) provides a range of services including development and scaleup, product characterisation, analytical development & qualification and process trouble shooting, as well as offering some non GMP manufacturing services.
PHE manufactures Erwinaze™ , used to treat Acute Lymphoblastic Leukaemia and licensed in a number of territories, including the USA, and the UK’s anthrax vaccine, a key biodefence medical countermeasure. We also have experience in taking products to clinical trial.
Having developed our own products for many decades and worked with a wide range of customers, PHE D&P has a wealth of experience that can be applied through a flexible project management to aid clients at all stages of the development pathway.
• Process development and design of experiments
• Scale-up
• Microbial fermentation
• Product charaterisation
• Analytical development services
• Process and analytical validation
• Vaccines
• Therapeutics
• High containment capabilities
• Biodefence
• Biosafety and biosecurity
• GMP and Regulatory submissions and advice