Pharmaceutical Development

Porton Biopharma – Erwinase® manufacturing schedule

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 Yes Thursday 29th November 2018
192 Yes Friday 25th January 2019
193 Yes Tuesday 9th April 2019
194 Yes Wednesday 12th June 2019
195 Yes Friday 9th August 2019
196 Yes Tuesday 12th November 2019
197 Yes Friday 27th September 2019
198 Yes Monday 18th November 2019
199 Yes Monday 9th December 2019
200 Yes Friday 21st February 2020
201 Yes Wednesday 8th April 2020
202 Yes Thursday 24th September 2020
204 Yes Monday 9th November 2020
205 Product filled QC testing ongoing  
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 building

3000L building

3000L fermenter hall

3000L fermenter hall

DSP Centrifuge

DSP Centrifuge

Development Labs

Development Labs

Development fermentation suite

Development fermentation suite

Dispensary

Dispensary

Filling and freeze-drying building

Filling and freeze-drying building

Freeze Dryer

Freeze Dryer