PBL opens doors at UK bio-development centre
The Atkinson Development Centre was officially opened on Friday, adding 400 m2 of laboratory space, plus associated plant room at Porton Biopharma Limited’s (PBL) biomanufacturing site in Salisbury, UK.
“This is a developmental facility that undertakes work to support ongoing research and development into improved characterisation of current and pipeline products,” Commercial & Marketing manager Phil Luton told this publication.
The centre includes a bank of four 20 litre process-controlled fermenters and an additional 50 litre bioreactor that will enable parallel studies on the growth and scale-up of a range of microorganisms under a variety of conditions.
Material made in the fermenters will then be transferred to downstream processing laboratories for the purification and analysis of the compounds.
As well as being used for PBL’s own product portfolio – which includes Acute Lymphoblastic Leukaemia drug Erwinase (asparaginase Erwinia chrysanthem) marketed by Jazz Pharmaceuticals, and the UK’s anthrax vaccine – the firm will offer its capabilities to academia and industry as a third-party service.
In January, the firm was hit by a US Food and Drug Administration (FDA) warning letter citing deficiencies relating to aseptic operations at its manufacturing plant.
PBL is currently undergoing a remediation plan, with Luton telling us: “We have a comprehensive Compliance Action Plan to address the concerns raised by the FDA.”
