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:
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. The table on the following link summarises batch manufacture and availability, and is regularly updated on the manufacturing schedule page.
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.