Interview Dr Paul Beckett
Intensified bioprocessing is driven by economic and efficiency concerns but it also has a direct impact on sustainability. There is however limited quantified data on how these new efficiencies actually contribute to sustainability metrics. Dr Paul Beckett, Senior Manager Downstream, BioContinuumTM Platform explains which sustainability metrics are commonly used and presents a case study comparing the sustainability metrics of a current downstream bioprocess with an intensified process.
Beckett is responsible for the strategy and development of the downstream portion of the BioContinuum platform at Merck KGaA Darmstadt. This platform focusses on next-generation intensified and continuous bioprocessing and the preparation for the facility of the future (BioProcessing 4.0). “The pharmaceutical industry is a conservative and highly regulated industry so there needs to be a very strong incentive for change”, says Beckett. For example biologicals need a lot of expensive clinical work and once the manufacturing process has been approved this is not easily changed due to regulatory concerns, cost and time. “However we need to change”, stresses Beckett, “since drugs are too expensive and our manufacturing needs to be more flexible. We have to reduce that cost somehow by making our manufacturing cheaper, faster and smaller. It is a happy coincidence that when you make something smaller and more efficient it also has less of a sustainability impact.”
Sustainability metrics
“Sustainability specialists talk their own language, use all kinds of metrics and finally there appears a number which you need to know where it comes from and what it means. To understand how bioprocesses contribute to sustainability we need understandable numbers using the right metrics,” says Beckett. “I want to present a case study which is understandable and applicable for a bioprocess audience who are not necessarily sustainability experts.”
Case study
Beckett uses three different metrics in his case study: PMI, (process mass intensity, the total mass of materials needed per mass of product), carbon dioxide equivalent (a measure of the carbon/warming footprint of a process) and freshwater use (water for injection).
The processing steps of a reference (classic) batch mAb purification process and an intensified version serve as the basis of the case study. Examples of intensification include flocculation of the cell culture before depth filtration in primary harvest. Flocculation is the aggregation of smaller particles into larger agglomerates which makes the filtration process more efficient, therefore using less filter area. Another example is replacing cation exchange chromatography (CEX) by frontal CEX. This shrinks the operation due to the much higher apparent binding capacity, using less resin and therefore significantly reducing buffer demand. Some steps in the process like virus filtration do have continuous and intensified options but the impact on sustainability at this point in time is minimal and therefore has been excluded
Lower freshwater use
The conclusion is that the intensified versions of the primary harvest step and cation exchange chromatography use a lot less freshwater and they also have a lot lower PMI and therefore are more sustainable. Saving a lot of water that does not need to be purified, chemicals and also filters/resins makes a huge difference on the scale of costs and sustainability. “These are promising results but should be seen as only the first part of a much more comprehensive study.”
Paul Beckett Senior Manager Downstream, BioContinuumTM Platform gives the opening key-note lecture Impact of intensified bioprocessing on sustainability at The Single Use Event at 10.35 am, September 13.
Dr. Paul Beckett gave this interview before his lecture at the Single-Use Event 2022