Question to the Department of Health and Social Care:

To ask the Secretary of State for Health and Social Care, pursuant to the Answer of 18 January 2019 to Question 207238 on Asparaginase, what steps Porton Biopharma will take to increase capacity of erwinase and better supply the (a) UK and (b) world market for the remainder of 2019.

Porton Biopharma Ltd (PBL) are implementing a series of initiatives to increase capacity and supply in both the short and long term. These include the following:

- Extending operational activities to 24 hours a day, seven days a week to maximise fermentation of the product;

- Implementing an ongoing capital programme including construction of a new pharmaceutical fermentation facility. The facility was completed in April 2018 and is currently undergoing testing; it has an increased capacity fermentation suite which will enable PBL to manufacture at larger scale and is due to start producing product Q3 2019 for regulatory approval to market;

- A new filling and freeze-drying building was completed in February 2016. The installation of a new filling line which covers the entire process, including vial washing, filling, stoppering and freeze drying. The new line has been designed with systems which monitor all critical parameters throughout the process to accelerate batch release and will accommodate increased capacity. The beneficial use of this and the fermentation facility will coincide to maximise increased product output; and

- Sourcing replacement suppliers, including for new stoppers and new vials for the product, ensuring that maximum batch sizes can be achieved with minimal product rejects. This programme is complete.

PBL has made significant investments into increasing product capacity and will continue to release future batches as soon as they become available to Jazz Pharmaceuticals (who are responsible for the packaging/distribution and allocation of worldwide product supply).