Rapid evolution of the biopharmaceutical market has drawn focus to the limitations of current purification operations demanding a step-change improvement in processes. Growth of the biosimilars and emerging markets, along with a trend to outsource more production is putting a spotlight on COGS. Drug manufacturers are facing increasing pressure from payers worldwide to deliver more efficacious therapies at a lower cost. Bioprocessing developments must focus on process efficiency, flexibility and plant productivity to impact healthcare in a meaningful way.
Puridify’s platform purification technology, FibroSelect, aims to enable new processing strategies through significant advantages across key performance attributes, improving process flexibility and robustness, and meeting the industry demands of today and as the market evolves. The FibroSelect material exhibits a novel proprietary structure that overcomes the diffusional and flow limitations of packed bed chromatography purification systems and the capacity issues of chromatography membranes. It also addresses the process robustness issues of predicting scaled performance due to the material’s fixed structure which exhibits uniform purification performance at all scales. This, in combination with its macroporosity, also gives it strong potential as an enabling technology for the purification of next generation macromolecular biotherapeutics such as gene therapies, viral vectors and fusion proteins.
We have proven at research and pilot scale that the technology can operate at 50x throughput due to optimal permeability and mass transfer characteristics. This improves process economics by achieving 10-50 fold productivity improvements as well as benefiting labile products. The reagent has shown better resistance than our competitors to impurity fouling and cleaning steps, a common cause of performance degradation over multiple cycles. With novel HTPS tools for use with robotic platforms and chromatography runs that take just 3 minutes at research and process scales, FibroSelect enables extremely rapid bioprocess development opportunities with predictable performance at all scales improving process robustness.
See the following papers for more information:
Hardick et al. (2011), ‘Nanofibre fabrication in a temperature and humidity controlled environment for improved fibre consistency’, Journal of Materials Science, 46 (11), pp. 3890-3898
Hardick et al. (2013), ‘Nanofiber adsorbents for high productivity downstream processing’, Biotechnology and Bioengineering, 110 (4), pp. 1119-1128
Hardick et al. (2015), ‘Nanofiber adsorbents for high productivity continuous downstream processing, Journal of Biotechnology, 213 pp. 74-82