AUSTRALIA’S DOMESTIC PLASMA PRODUCTS WILL TRANSITION IN 2023

Under the National Fractionation Agreement for Australia in place between the National Blood Authority and CSL Behring, CSL Behring has been investing in new facilities at its manufacturing site at Broadmeadows in Victoria to provide expanded capacity for processing Australia’s growing annual domestic plasma collections.

Under this transition the manufacturing process for five of Australia’s domestic plasma products will change. The products will continue to be manufactured in Australia from Australia’s plasma, but will be manufactured using CSL Behring’s global manufacturing processes. As per the current products, the transitioned products will comply with the safety and efficacy requirements set by the Therapeutic Goods Administration.

The product transitions are shown in the table below. The trade names of the transitioned products reflect their manufacturing process, while the AU denotes the product is manufactured from plasma collected in Australia.

Current Product

Transitioned Product

INTRAGAM 10

(10% intravenous immunoglobulin)                          

PRIVIGEN AU

(10% intravenous immunoglobulin manufactured using the PRIVIGEN process)

EVOGAM

(16% subcutaneous immunoglobulin) 

HIZENTRA AU

(20% subcutaneous immunoglobulin manufactured using the HIZENTRA process)

ALBUMEX 4

(4% albumin)

ALBUREX 5 AU

(5% albumin manufactured using the ALBUREX process)

ALBUMEX 20

(20% albumin)

 

ALBUREX 20 AU

(20% albumin manufactured using the ALBUREX process)

PROTHROMBINEX-VF

(prothrombin complex concentrate containing clotting factors II, IX      and X)

BERIPLEX AU

(prothrombin complex containing clotting factors II, VII, IX and X manufactured using the BERIPLEX process)

 

Planning for the product transitions has commenced in consultation with Lifeblood. Expert Clinical Groups (clinicians and nurses) have also been convened by CSL Behring to provide expert advice regarding clinical matters necessary to ensure the safe and seamless transition of all five products.

The first of the transitioned products are estimated to become available in hospitals from late quarter 1 calendar year 2023 with the remaining products transitioned in over a 12 month period. The last product to transition, BERIPLEX AU, will become available during early calendar 2024.

Details on the product changes will be provided in the coming months including timings and information on the transitioned products, including barcoding and label changes.

Please direct any queries to Supply.Management.Plasma@blood.gov.au.