Octapharma Extends Use of BAC Technology for Manufacture of G-CSF Custom Ligand
Custom-designed affinity chromatography media decreases downstream processing.
Octapharma entered into a license agreement with BAC to use the latter’s G-CSF CaptureSelect® custom affinity ligand for the purification of recombinant human granulocyte-colony stimulating factor (G-CSF) from human (HEK293F) cell cultures. Existing G-CSF products are marketed as Filgrastim (E. coli derived) and Lenograstim (CHO derived).
This license follows success in an earlier feasibility study program in which BAC discovered and developed the anti-G-CSF ligand in close collaboration with Octapharma. This custom-designed affinity chromatography media enables Octapharma to rapidly set up a production process for this recombinant protein as it reportedly decreases the time needed for downstream process development. More traditional methods include various chromatography steps resulting in a lower recovery of the overall process compared to using affinity chromatography.
BAC’s CaptureSelect ligand technology is based on selection of Camelid single-chain antibody fragments with desirable chromatographic characteristics including robustness, high specificity, and flexibility. Suitable ligands are cloned and expressed in high titres through an animal-free Saccharomyces cerevisiae-based process. CaptureSelect ligands are made available through the company’s custom design service or as off-the-shelf bioprocess products through commercial partners.
“The start of this collaboration with BAC, in G-CSF, came from the success with our previous collaboration to develop a ligand for the purification of factor IX and the use of a BAC-derived ligand for affinity purification of recombinant factor VIII (the product is currently in clinical trials),” points out Kim Björnstrup, vice chairman of Octapharma Group. “Our aim is always to provide safe products of the highest purity, and BAC’s ligands are a key part of our purification process.”
G-CSF is a hormone that stimulates bone marrow to produce white blood cells as well as stem cells and has therapeutic uses in oncology and hematology. Octapharma will produce G-CSF for use primarily within the field of oncology, for example, after chemotherapy and/or bone marrow transplantation.