PBL’s Pharmaceutical Fermentation Facility, United Kingdom


PBL

Porton Biopharma Limited (PBL) started construction of a new pharmaceutical fermentation facility at the Porton Down Science Park located near Salisbury, Wiltshire, UK, in May 2016. The facility is expected to be ready for operation by 2018.

It will be PBL's second major investment after opening of a multimillion pound new freeze drying facility in November 2015. The new facility will help PBL to develop and produce a range of life-saving products.

Details of PBL's pharmaceutical fermentation facility

The new fermentation facility will spread over 21,000m² area and will be used for manufacturing medical products in a modern environment, which will be constructed fully in compliance with the latest pharmaceutical regulations. It will be equipped with a fermenter, process train and associated utilities to develop a range of life-saving products.

The new facility will include a viewing gallery that will allow visitors to see the high-tech process without having to go through the gowning-up process that is obligatory for entering clean room pharmaceutical manufacturing facilities.

PBL is currently continuing to manufacture in its existing plant, but addition of the new plant will bring the new capacity on stream to meet the increasing global demand for its product.

Construction of the fermentation facility in Sailsbury

The groundbreaking ceremony for the construction of the pharmaceutical fermentation facility was held in May 2016, which was attended by John Glen, MP of Salisbury.

The new facility's construction will be followed by demolition of older facilities and construction of a new workshop and a water plant room to support the facility. The equipment installation and pharmaceutical validation will be implemented at the newly constructed facility in a phased programme.

Technology and production process at the new fermentation facility

The new facility will be equipped with technical capabilities to translate research methodologies into production processes. It will include capabilities from 2L benchtop fermenters to 100L production vessels, cell processing, prokaryotic and yeast fermentation. It will also include a range of production platforms, including Wave™, roller bottles and multi-layer disposable vessels.

"It will be PBL's second major investment after opening of a multimillion pound new freeze drying facility in November 2015."

The plant will also include product purification technology with sophisticated analytical methods including LC-mass spectrometry, HPLC, UPLC, electrophoresis, ELISA and dynamic light scattering. It will use in process and final product analysis including forced degradation studies and stress testing.

Products produced at the fermentation facility

PBL is the sole manufacturer of the UK-licensed anthrax vaccine, which is manufactured for, and on behalf of, the UK Government and supplied for occupational health purposes and to protect service personnel from the use of anthrax as a biological weapon.

PBL is working together with US Company NanoBio to develop next-generation anthrax vaccine at the new facility in Wiltshire.

PBL also produces Erwinase®, which is used for the treatment of acute lymphioblastic leukaemia (ALL) in children. The drug was approved by the US FDA in November 2011. It is also registered in 20 countries and commercialised in more than 75 countries world-wide. Erwinase is distributed and commercialised by Jazz Pharmaceuticals worldwide.

Marketing commentary

Based at Porton Down in Wiltshire, UK, PBL was established in April 2015 to commercialise the pharmaceutical development and manufacturing capabilities that were previously within Public Health England.

The company offers expertise in development and production of biologicals, including product characterisation, process and analytical validation and scalability for market. It also develops new vaccines, therapeutic proteins and enzyme products and also undertakes contract manufacturing at all stages of the product development/commercialisation lifecycle.