PBL continues to supply Erwinase® finished product batches on time.
PBL has made significant investment in resources and devoted effort into ensuring that it manufactures and delivers its life-saving product Erwinase® on schedule.
Table of finished product batches
|DP Batch number||Batch Manufactured||Batch available for collection|
|191||Thursday 29th November 2018|
|192||Friday 25th January 2019|
|193||Tuesday 9th April 2019|
|194||Wednesday 12th June 2019|
|195||Friday 9th August 2019|
|196||Tuesday 12th November 2019|
|197||Friday 27th September 2019|
|198||Monday 18th November 2019|
|199||Monday 9th December 2019|
|200||Friday 21st February 2020|
|201||Wednesday 8th April 2020|
|202||Thursday 24th September 2020|
|204||Monday 9th November 2020|
|205||Friday 27th November 2020|
|206||Product filled QC testing ongoing|
PBL staff across the whole company are committed to the importance of making batches available on time for release to our current sales and distribution partner Jazz Pharmaceuticals. Erwinase® is a critical healthcare product essential to children fighting acute lymphoblastic leukaemia which is the commonest form of childhood cancer.
As part of our commitment, PBL has, during the last year introduced new product components including bromo-butyl stoppers and 3ml type 1 borosilicate clear-glass vials to improve compliance, ensure our product conforms to the highest specifications and meets the quality standards required. More information on Erwinase supply is available here.
In addition, over recent years, PBL has implemented a series of initiatives to increase product capacity and have invested over £50m creating state of the art manufacturing facilities including a new 3000L fermentation facility, plus a new filling line and freeze-drying unit. PBL is striving to ensure these new facilities come on-line as soon as possible to meet and exceed future demands for Erwinase®.
PBL recently received a request under Freedom of Information regarding the process for release and distribution of Erwinase®. Since that information is in the Public Interest a copy of the request and our response is being provided. PBL FOI Response letter FOI-010-20
*Batch 203 did not meet PBL’s robust and stringent release procedures.
3000L fermenter hall
Development fermentation suite
Filling and freeze-drying building