PBL 3,000L Plant Could Alleviate Erwinaze Shortage

Porton Biopharma Limited (PBL) has opened a facility in Wiltshire, UK to make cancer drug Erwinaze (asparaginase Erwinia chrysanthemi).

PBL is a biomanufacturer owned by the UK Government. Construction of the 2,100 m² facility began in May 2016, through a multi-million pound investment from the UK’s Department of Health Capital funding.

The plant has opened its doors and full production is set to commence over the next 12 months once the process of qualifying and validating the equipment is complete.

“This facility will be the main Erwinaze [known as Erwinase outside of the US] production facility when on-line and will enable us to   increase capacity from our current production facility,” PBL spokesperson Phil Luton told BioProcess Insider.

The facility is built around a stainless steel bioreactor, supplied by Pierre Guerin with a working volume of 3,000 L. It is also houses downstream processing rooms for harvesting product.

And according to Luton, PBL will be recruiting more production staff “to enable us to run this facility up whilst we maintain our current manufacturing.”

Erwinaze Manufacturing Issues

Erwinaze is an asparaginase enzyme derived from the bacteria Erwinia chrysanthemi, used for the treatment of patients with acute lymphoblastic leukemia (ALL) who have developed hypersensitivity to E. coli-derived asparaginase.

PBL is the sole manufacturer of the drug for biologics license application (BLA) holder Jazz Pharmaceuticals.

The new facility will enable PBL to increase the amount of Erwinaze/Erwinase it will be able to manufacture and could alleviate an ongoing shortage of the drug caused by issues at PBL’s current production plant at its Wiltshire site.

The Food and Drug Administration (FDA) sent PBL a warning letter in January 2017 citing deficiencies relating to aseptic operations, failures in investigating particulate matter observed in batches of Erwinaze, and problems with PBL’s management of process changes surrounding the working cell banks.

Supply Disruptions

Luton did not comment directly on the warning letter or the ongoing drug shortage.

Speaking this week on a financial call, Jazz CEO Bruce Cozadd said his firm continues to face supply disruptions.

“We are working with the manufacturer to do everything we can to improve quality, reliability, capacity and ultimately reliability of supply,” he told stakeholders (see transcript here).

“But that effort is not one that can be finished quickly. It’s a lot of work and with a long cycle time of manufacturing. Even successful improvements take a while to result in actual increased supply to the market.”