NR AXNS
AU Gröner,A.; Schäfer,W.
TI Precipitation of Prion Protein Facilitates Formation and Removal of High Molecular Aggregates
QU International Conference - Prion 2007 (26.-28.9.2007) Edinburgh International Conference Centre, Edinburgh, Scotland, UK - Book of Abstracts: Oral Abstracts FC5.7
IA http://www.prion2007.com/pdf/Prion Book of Abstracts.pdf
PT Konferenz-Vortrag
AB
Background: Investigational studies demonstrating the prion reduction capacity of the manufacturing procedures of biologicals are performed by spiking product intermediates with prion material and running the manufacturing process at lab scale. Under certain conditions the total clearance of two combined manufacturing steps did not approximate to the sum of the individual steps, as from the heterogenous spike one fraction was preferentially removed by both steps.
Aims/Objectives: Studies were performed to evaluate the modification of a subfraction not removable by the manufacturing steps in a way that it could be removed by standard methods inherent in the manufacturing procedures for biologicals.
Methods: Prion protein, usually spiked to intermediates of biologicals, was processed and fractionated in low and high molecular prion aggregates. The low molecular aggregates were precipitated by different means and the precipitate collected by centrifugation or filtration. The precipitate was then solubilised and the protein solution subjected to process steps, differentiating subfractions of prion protein aggregates.
Results: Process conditions resulting in the modification of low molecular prion aggregates to high molecular prion aggregates will be presented.
Conclusion: The heterogenicity of prion spike material can be overcome by implementing further process steps in the manufacturing procedure of biologicals resulting in the removal of all subfractions of prion material. This allows for further improvement of the prion reduction capacity of the manufacturing process.
AD A. Gröner, W. Schäfer, CSL Behring, Virology, Germany
SP englisch
PO Schottland