For many, continuous processing is the future of the biopharma industry, and yet there are still numerous concerns over its implementation. For Margit Holzer, Scientific Director at Ulysse-Consult and consultant at Ypso-Facto, the reasons to pursue it are numerous: “We want to shrink process lines and make them portable. We also expect improved quality attributes due to reduced product hold times and more controlled processing”.
She adds that the need to reduce costs within the biomanufacturing industry will see “cost reduction of Capital Expenditure and operational costs like raw materials, utilities, labour and waste”. For Dr. Holzer, it is clear that implementation of more characterised and optimised process lines being run partially or entirely continuously will help achieve these reductions for many future products. And if that’s not enough, she also points out that the “FDA encourages continuous processing”.
When designing a continuous processing facility a vast number of factors need to be taken into account. Dr. Holzer encourages anyone considering it to first answer a series of questions before they commit:
- Do you want a dedicated or multiproduct facility?
- Will you adopt a platform approach? If so it needs to be defined.
- How will you arrange process transfers?
- Do you have back-up plants?
- Are you hoping to achieve end-to-end continuous, fully continuous, or continuous process steps?
- Are the development labs & strategy in line with manufacturing?
- Will you integrate disposables?
Within any continuous system, Dr. Holzer emphasises that process-control strategies are key:
“It’s vital to define process monitoring parameters & in-process control strategy. Spectroscopic methods for in-line or at-line measurement and chromatography based methods coupled with different detectors are examples of robust PAT. Equally, how to integrate cleaning and sanitisation strategy in the overall process outline must be established.”
Process simulation tools, like ChromWorksTM for chromatography, are a great help for visualising, designing, optimising and validating integrated continuous processes and can really speed up development.
Alongside Ypso-Facto founder & CEO, Dr Roger-Marc Nicoud, Dr. Holzer is offering a workshop for anyone interested in continuous processing, which will give an overview of the technologies available, as well as cost studies and guidelines on important practical considerations based on their considerable experience. She explains that “based on the lessons learnt during the workshop you will be able to build your case and define the relevant questions to be raised before you commit to continuous bioprocessing”.
The workshop – Continuous Processing: Challenges, Technologies, Processes, Economics & Strategy – is running on 11th April 2016 as part of BioProcess International European Summit. Find out more and register here.