Pictured: CSIRO Tissue Culture Facility team Tam Pham, Louis Lu, Mylinh La, George Lovrecz, Tram Phan
Biologics are the fastest-growing 'pillar' of the biopharmaceutical industry, largely due to their specificity and tolerability (resulting in a generally faster regulatory approval process) and the success of key blockbuster products, particularly in the antibody space.
This project is aiming to upgrade the CSIRO protein production platform at Clayton to human Good Manufacturing Process (GMP) capability for pilot-scale (less than 200L) for a variety of expression systems (mammalian/yeast/ bacterial) as well as scale-up of cells.
The proposal extends beyond a facility upgrade to encompass a CSIRO and Monash collaboration to support training in quality systems, GMP, analytics and bioprocess development. To achieve this the facilities will be developed with teaching requirements as part of the plan.
Outcomes: This project will deliver and commission equipment for a facility to produce small volumes of cells for Phase II and Phase III human clinical trials. Production is underway and the facility is almost complete.
|State||Australian Capital Territory|
|Consortium Members||Monash University|
|State Government Contribution||$750,000|
|Project Duration||August 2019 - June 2022|
|Contact||Mariann Fee, CSIRO - email@example.com +61 3 9545 2239|