The Development and Production (D&P) Department of Public health England (PHE) has been working with the pharmaceutical, biotechnology and healthcare sectors of industry for more than 50 years, undertaking contract research, development and production of products.
We have particular expertise in taking concepts from the research laboratory (either in-house or from our customers) 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 scale-up, product characterisation, analytical development and qualification, and process troubleshooting, as well as offering some non-GMP manufacturing services.
PHE has state-of-the-art cGMP manufacturing facilities, licensed by the MHRA and FDA at our centre at Porton Down, Salisbury, for the manufacture of our own biopharmaceutical products. These include the only anthrax vaccine licensed in Europe (AVP) and Erwinazea™, a therapeutic enzyme which is used to treat acute lymphoblastic leukaemia (ALL) and licensed in a number of territories worldwide, including the US.
In addition to our own products, our manufacturing and filling facilities are utilised for the production of a wide range of clinical materials for our clients. Our unique containment level 3 capabilities are geared to the bespoke manufacture of low volume, high potency / toxicity bacterial products.
Our customers range from start-up biotech to large pharma organisations on a worldwide basis. We also have active collaborations with academic departments engaged in bioprocessing development and several of our staff serve as visiting university lecturers. This means that we are able to offer our customers a broad spectrum of developmental capabilities, ranging from the creation of entire biopharmaceutical manufacturing schemes from research scale methodologies, to the development of individual process components. For example, cell banking, fermentation and product purification.
Our extensive experience in the controlled transfer of processes and associated methods, both within our own organisation and internationally for our clients, gives customers assurance of the accurate replication of such processes within a new developmental or cGMP manufacturing environment.
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. Our project management systems promotes a high-level of communication between ourselves and the client at all stages of the development process. This enables us to advise in the event of unexpected outcomes and adapt rapidly to changing customer needs or commercial priorities.
Specialist expertise focused on translational development in public health
Translational development and cGMP manufacture of our own healthcare products has arisen from many decades of fundamental research into pathogenesis and novel therapies. Our staff have hands-on experience of cGMP and working under high-levels of microbial containment (up to biocontainment level 3) with many years of expertise in bioprocessing and analysis. Our expertise covers a wide portfolio of microbial and biopharmaceutical product types developed and manufactured in-house and for our customers.
We offer access to our specialist laboratories and bespoke services for translational research and development to help develop new public healthcare products, specialising in the development of vaccines and therapeutics against infectious diseases and being able to go from gene to GMP to bring your discoveries to life.
Process redevelopment and qualification
Experience gained from the continuous improvement of our own processes enables us to offer a complete range of services to clients, including complete process redesign, introduction of disposable technology and improved analytical methods. Such activities are underpinned by the expert knowledge of our regulatory and validation teams.
Analytical development and qualification
Our Process and Analytical Development Group designs and adapts a wide range of analytical techniques to demonstrate process reproducibility and product quality. Method qualification ensures that such techniques are fit for their intended purpose.
Process analytical validation
Our clients benefit from our extensive experience in validating our own processes and methods. Critical processes and analytical method parameters are identified at an early stage in the development cycle, operating limits defined, often using scale-down technologies, and finally verified at manufacturing scale.
Long-established manufacturing processes may suffer from unexpected problems. Our staff are adept at determining the root cause of process failures outside of the manufacturing environment to reduce costs and manufacturing down- time and advising on the appropriate remedial action.
Public Health England's 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.
In order to find out how we can help you move your research from the bench to the clinic, please contact our Business Development Department using the details below.
Development and Production
Public Health England
Manor Farm Road
Available White Papers
HPA Case Study: Analytical Method Development Regulatory authorities are increasingly placing greater emphasis on analytical methods in manufacturing. This is particularly so with biopharmaceuticals where the requirement is often for a wide, diverse range of analytical methods to fully understand both product and process.
HPA Case Study: Development of a Manufacturing Process for a Biodefence Vaccine The Process & Analytical Development Group (PADG) has recently completed the final development of a manufacturing process for an important biodefence vaccine on behalf of a US contractor.
HPA Case Study: Production of Non-GMP Biologicals The Process & Analytical Development Group has supplied a variety of customers with a broad range of microbial products. Our expertise in protein analysis and enzymology mean that our products are well-characterised and of the required quality.
HPA Case Study: Technical Support for FDA Licensure of Erwinaze™ Erwinaze™, a biotherapeutic used for the treatment of acute lymphoblastic leukemia (ALL), is manufactured by the HPA in its cGMP facilities at Porton Down and is currently distributed to over 50 countries worldwide by EUSA Pharma.