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1039028
star this property registered interest false more like this
star this property date less than 2019-01-10more like thismore than 2019-01-10
star this property answering body
Department of Health and Social Care more like this
star this property answering dept id 17 remove filter
star this property answering dept short name Health and Social Care more like this
star this property answering dept sort name Health and Social Care more like this
star this property hansard heading Asparaginase remove filter
star this property house id 1 more like this
star this property legislature
25259
star this property pref label House of Commons more like this
star this property question text To ask the Secretary of State for Health and Social Care, whether Erwinase will be available for the treatment for children with acute lymphoblastic leukaemia between January 2019 and March 2019; and if he will make a statement. more like this
star this property tabling member constituency Crawley more like this
star this property tabling member printed
Henry Smith remove filter
star this property uin 207238 more like this
star this property answer
answer
star this property is ministerial correction false more like this
star this property date of answer less than 2019-01-18more like thismore than 2019-01-18
star this property answer text <p>Erwinase is produced by Porton Biopharma Ltd (PBL) and is licensed and distributed by Jazz Pharmaceuticals under a global licencing agreement.</p><p> </p><p>Due to increased demand for Erwinase and because PBL are manufacturing at capacity, until increases in capacity are brought into beneficial use there will be occasional stock-outs.</p><p> </p><p>The product is currently in stock in the United Kingdom. The Department has been informed, it is likely there will be a short stock-out in early February 2019 and then a further batch is planned to be released to Jazz Pharmaceuticals, who are responsible for the packaging/distribution and allocation of worldwide product supply, anticipated to reach the UK market by mid-February 2019 which should last until the end of March 2019.</p><p> </p><p>The Department and Public Health England (PHE) are in close contact with, and have been kept informed by the PBL management of short periods of interrupted supply. PBL have and will be implementing a series of initiatives to increase capacity and better supply the market in both the short and long term. PBL are fully aware of the consequences that the unavailability of Erwinase has on patients and are absolutely committed to working with all involved to resolve any issues and be able to supply this critical medicine.</p><p> </p><p>The Department and PHE will continue to monitor the situation closely.</p>
star this property answering member constituency Winchester more like this
star this property answering member printed Steve Brine more like this
star this property question first answered
less than 2019-01-18T12:18:00.113Zmore like thismore than 2019-01-18T12:18:00.113Z
star this property answering member
4067
star this property label Biography information for Steve Brine more like this
star this property tabling member
3960
unstar this property label Biography information for Henry Smith more like this
1050101
star this property registered interest false more like this
star this property date less than 2019-01-28more like thismore than 2019-01-28
star this property answering body
Department of Health and Social Care more like this
star this property answering dept id 17 remove filter
star this property answering dept short name Health and Social Care more like this
star this property answering dept sort name Health and Social Care more like this
star this property hansard heading Asparaginase remove filter
star this property house id 1 more like this
star this property legislature
25259
star this property pref label House of Commons more like this
star this property question text 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. more like this
star this property tabling member constituency Crawley more like this
star this property tabling member printed
Henry Smith remove filter
star this property uin 213322 more like this
star this property answer
answer
star this property is ministerial correction false more like this
star this property date of answer less than 2019-02-05more like thismore than 2019-02-05
star this property answer text <p>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:</p><p>- Extending operational activities to 24 hours a day, seven days a week to maximise fermentation of the product;</p><p>- 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;</p><p>- 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</p><p>- 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.</p><p> </p><p>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).</p>
star this property answering member constituency Winchester more like this
star this property answering member printed Steve Brine more like this
star this property question first answered
less than 2019-02-05T15:09:48.903Zmore like thismore than 2019-02-05T15:09:48.903Z
star this property answering member
4067
star this property label Biography information for Steve Brine more like this
star this property tabling member
3960
unstar this property label Biography information for Henry Smith more like this