PBL is acutely aware of the importance of Erwinase® for children suffering from acute lymphoblastic leukaemia (ALL) and is committed to manufacturing the product such that it conforms to the highest specification meeting all quality standards required.
The supply of the product is our number one priority and to demonstrate our commitment to patients, doctors and regulatory authorities over the last two years PBL has:
- Improved availability of product for collection by our distributer by consistently manufacturing batches. Since November 2018, all batches have been released on time and to schedule.
- Ensured that each and every batch meets the quality standards required by release through Qualified Persons and independent review by regulatory consultants from an international global company
- Fully resolved an historical problem with a component by replacing the supplier, validating the new component and demonstrating this by manufacturing 15 batches without a reoccurrence of the problem
As manufacturer PBL is responsible for producing the product, filling, testing and ensuring that it meets specification. The product is then released and made available for collection by Jazz Pharmaceuticals who are responsible for labelling, packaging and release to the market.
Whilst PBL are producing consistent high-quality batches on schedule, we are unable to influence the time taken for collection and the subsequent release to market.
On average, after taking samples for QC testing, each batch released and available for collection contains approximately 16,000 vials. Assuming that an average 10-year-old child needs 75 vials to complete their treatment, then each batch is sufficient to treat approximately 213 children.
For more information on how PBL resolved the historical the problem with the component used in the aseptic filling of Erwinase® and why we have confidence in the quality of our product, we are providing the attached downloadable technical overview:Particular about Particulates PBL Presentation 2019 updated 2020