Porton Biopharma – Erwinase® manufacturing schedule

Pharmaceutical manufacture

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 Friday 15th November
199 Monday 9th December
200 Product filled QC testing ongoing
201 Manufacture scheduled*
202 Manufacture scheduled*

* planned within the current financial year

 

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.

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®.

3000L building

3000L fermenter hall

DSP Centrifuge

Development Labs

Development fermentation suite

Dispensary

Filling and freeze-drying building

Freeze Dryer