This is an important validation of the Gradiflow system and comes at a time when Gradipore's primary electrophoretic gels business has been hit by manufacturing problems.
Gradiflow is being developed as a commercial-scale separation system and, in the latest development, Gradipore and partner Serologicals have successfully scaled up a process used to purify hyperimmune immune globulin G (IgG) from plasma. Plasma-derived IgG is used for passive immunisation therapy, in which patients are given antibodies to bolster their immune system.
The Australian firm had already demonstrated the feasibility of separating IgG at an analytical scale (the company's BF-400 unit) and has now shown this can be replicated in a Good Manufacturing Practice-compliant production setting, via a unit known as GF-100. This system is 500 times bigger than its analytical cousin, according to the firm.
The process is being developed hand in hand with a Drug Master File (DMF) for the Gradiflow technology, which would allow it to be used in the production of commercial biological products. Gradipore also has haematological separation projects in place with Advantek Biologics and Cangene.
Last month, Gradipore unveiled a 200-day plan to get the business on a more commercial track from its former research-focused model. For Gradiflow, the focus will be on identifying and developing a therapeutic application, completion of the DMF and applying for the first therapeutic drug application (by the end of the fiscal year on 30 June).