November 1-5, 2015
Continuous processing offers significant advantages for the processing of unstable recombinant products such as therapeutic plasma proteins. As such we have established a development platform to assess potential purification steps as part of a continuous linear process using a standard AKTA Explorer. Following a consistent format of IEX membrane to HIC membrane to affinity resin, we were able to rapidly investigate multiple purification pathways for a recombinant blood protein. Using membranes as the first two steps enables a 3-step purification process to be carried out in 3 to 4 hours, with a total turnaround of 5 to 6 hours including regeneration and re-equilibration, at laboratory scale and depending on the specific pathway. This development method allowed for a direct comparison between multiple purification pathways, assessing overall recovery, pathway consistency, product quality and product purity over the 3 steps. Ligands tested include cation & anion exchangers, phenyl, phenyl boronate and an immobilised affinity peptide. It is envisaged that once a purification pathway has been decided upon, processing speed could be around 1 L per day without significant scale-up.
MIchael Hughson, Rimenys Carvalho, Thaynna Araujo Cruz, and Leda dos Reis Castilho, "Laboratory scale continuous linear purification as a development tool for recombinant blood protein processing, using chromatographic resins and membranes" in "Integrated Continuous Biomanufacturing II", Chetan Goudar, Amgen Inc. Suzanne Farid, University College London Christopher Hwang, Genzyme-Sanofi Karol Lacki, Novo Nordisk Eds, ECI Symposium Series, (2015). https://dc.engconfintl.org/biomanufact_ii/106