Bespoke Biopharmaceutical Manufacturing Services

Taking an original concept from the bench through to the production of GMP biopharmaceutical material for clinical trials is challenging. The world class expertise of the Health Protection Agency's centre at Porton Down in process development, scale-up and GMP manufacture can assist biotechnology companies to develop new vaccines, therapeutic proteins and enzyme products for today's market. We are able to offer a bespoke service designed to meet client needs and add value to client programmes. Our experience enables us to successfully manage novel products requiring a specialised service, including high containment. The Agency has its own portfolio of licensed biopharmaceutical products, which give us a clear understanding of the need to bring client products to market in a cost effective and efficient manner.

Biopharmaceutical Production Unit

The Biopharmaceutical Production Unit is capable of working with hazardous agents including pathogens up to Containment Level 3. The Biopharmaceutical Production Unit is comprised of three main facilities - a bulk active manufacturing unit, a formulation and fill unit and a production support unit - which allow the manufacture of material that complies with the GMP regulations for APIs and finished products.

HPA Expertise and Capabilities

• Project management
• Technology transfer
• Production development
• Assay development and validation
• GMP small scale production
• GMP contained production
• GMP pilot plant scale production
• Full quality oversight and management
• Fill/finish
• Product release

The Agency and the Client

Bringing Products to Market in a Cost Effective and Efficient Manner

A Project Manager will oversee the agreed scope of work for the client to ensure delivery within agreed timings. The Project Manager can call upon experts from across the HPA as required to bring detailed and practical knowledge of technology transfer, assay and production development. Quality and Business Management are integral parts of the project. An HPA Qualified Person (QP) and a Business Manager will be involved from the project initiation in planning and execution of the project, ensuring that quality, legal and regulatory compliance issues are clearly addressed. They also ensure that the production of materials is supported by the expected level of documentation, including manufacturing batch records, raw material monographs, plus that the facility and equipment is fully validated and calibrated. We invite clients to visit and audit the facility at the earliest possible date. Clients are fully informed on project progress via written reports, teleconferences or on-site meetings.

A Flexible Response Adding Value to the Client's Business

Currently the unit is set up for fermentation and downstream processing of bacterial cultures. The co-location of the Formulation and Fill Unit for the preparation of liquid fill or lyophilised parenteral products means that material can be processed ready for onward distribution. A Production Support Unit provides sterile media, reagents and equipment for manufacturing processes. We have an in-house Validation Department and engineering group. The Unit is supported by GMP compliant Quality Control laboratories.

Tomorrow's Products: Today's Markets

Our clients are typically SMEs with laboratory scale or research processes that require process development, scale-up and production of material for toxicology and clinical trials. Alternatively clients may already have a defined process which requires technology transfer and production of material on a campaign basis. The Agency offers a flexible response which will add value to a client's business.

Quality System

We are able to provide a Quality Management System and personnel, including a QP, to provide assurance that the products and services are fully compliant to client and regulatory requirements. The unit has been audited by many of the European and US organisations who place contracts with us. There is an in-house quality audit system and staff training schedule to ensure that the facilities and staff are operating to the expected level of compliance.

Facilities Overview

• Fully GMP compliant
• Can handle organisms up to and including Containment Level 3
• Flexible fermentation capabilities
• Dedicated HVAC serving Class A, B, C and D rooms
• Co-located Fill/Finish capability
• Dedicated effluent processing plant
• A wide portfolio of current down-stream processing
  and analytical equipment, as well as the ability tointroduce novel technology
• Dedicated on-site engineering services

Our stretegic goal is "to build on and develop the intellectual asserts of the organisation in partnership with industry" We aim to do this by developing partnerships which offers pratical and financial benefits for both parties.

Whatever your research,manufacturing or service requirements, contact us and find out about our unique range of services and what we can offer.

To find out more visit our contacts page