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TSE clearance during plasma products separation process by Gradiflow(TM)
Kailing Wang1, Annalese Johnson, Mina Obradovic
1Commercial Separations Division, Gradipore, NSW 2086, Australia. Kailing.wang@life-therapeutics.com
Summary
The Gradiflow system effectively removes transmissible spongiform encephalopathy (TSE) agents from plasma products like albumin and IgG. This preparative electrophoresis method offers a safe way to purify blood components and mitigate TSE transmission risks.
Area of Science:
- Biotechnology
- Prion Disease Research
- Blood Product Safety
Background:
- Transmissible spongiform encephalopathies (TSEs) pose a risk of transmission via blood products.
- New variant Creutzfeldt-Jakob disease (vCJD) has heightened concerns regarding blood component safety.
- Current strategies include plasma sourcing restrictions and leukodepletion to minimize TSE transmission risk.
Purpose of the Study:
- To evaluate the efficacy of a preparative electrophoresis system, Gradiflow, in removing TSE contaminants.
- To assess the capability of Gradiflow in purifying plasma products while eliminating TSE agents.
Main Methods:
- Hamster-adapted scrapie 263K was used as a model TSE agent.
- Albumin and IgG were separated from human plasma using the Gradiflow system.
- Samples were analyzed for the presence of PrP(Sc) before and after Gradiflow processing.
Main Results:
- Gradiflow processing achieved a greater than 3 log(10) reduction of TSE contaminants.
- No detectable PrP(Sc) was found in purified albumin or IgG products.
- The system demonstrated concurrent purification of plasma products and in-process TSE removal.
Conclusions:
- The Gradiflow process is a viable method for removing TSE agents during plasma product separation.
- This technology has the potential to eliminate the risk of TSE transmission through blood products.
- Gradiflow offers an effective solution for enhancing the safety of plasma-derived therapeutics.