Over the last decade, as awareness of climate change has continued to increase, corporate sustainability reporting and goals have moved from optional to table stakes. Companies of all sectors, including biopharmaceutical manufacturing, are evaluating their operations and setting more ambitious goals for reducing environmental impact.
One of the ways the biopharmaceutical manufacturing industry is working to reduce its environmental impact is by migrating toward single-use technologies. While seemingly counterintuitive, single-use products offer many benefits related to sustainability. A detailed life-cycle analysis (LCA) study published in 2013 compared the use of single-use versus durable process technologies for a standard monoclonal antibody (mAb) manufacturing process at different scales.1,2
3M Health Care’s Separation and Purification Sciences Division authored a new whitepaper that provides a general comparison of certain sustainability aspects of 3M’s single-use technologies versus more traditional, reusable technology.
The Importance of Process Intensification and Compression
Before dissecting these whitepaper findings, it’s important to understand the difference 3M single-use products offer in terms of process compression. 3M offers a variety of single-use products for the biopharmaceutical manufacturing industry, including depth filters, membrane filters, chromatographic clarifiers and membrane chromatography devices. The newest 3M technologies were designed to enable advanced process intensification and compression.
- 3M Harvest RC Chromatographic Clarifier is a single-stage clarification solution designed for the clarification of Chinese Hamster Ovary (CHO) cell cultures. The technology uses fibrous anion exchange (AEX) chromatography to separate cells, debris and soluble impurities based on charge rather than size, reducing this separation to a single step, avoiding centrifugation and multi-stage depth filtration.
- 3M Polisher ST is a single-use, flow-through solution that replaces a traditional multi-use AEX chromatography polishing column. The capsules combine two complementary AEX-functional media: a quaternary ammonium (Q) functional nonwoven and a guanidinium-functional membrane.The non-woven provides a tolerance for the turbidity that may be observed after virus inactivation and neutralization. This allows the elimination of a depth filter and membrane step, which reduces the number of steps and the floorspace in production.
As illustrated in this whitepaper, reducing or compressing steps in a process enables savings of resources like water or buffer. Reducing or compressing process steps also can lead to overall increases in product recovery which can increase annual plant capacity and the number of doses produced.
Single-Use Technologies Reduce PMI Value
The process mass intensity (PMI) value is a key performance indicator that can be used to evaluate the efficiency of a process. It is defined as the total mass of materials going into the process (including consumables, cleaning water, buffers, etc.) divided by the mass output of the final product.The PMI can be used as a measure of resource use efficiency, as lower values correspond to less waste. 3M single-use technologies allow for process intensification and simplification by combining multiple steps into one. Using these technologies standalone – but especially in combination – resulted in significantly reduced PMI (Figure 1).
Figure 1: Process mass intensity results for the modelled scenarios.
Effects of Individual 3MSingle-Use Technologies
To evaluate the environmental benefits of 3M single-use technologies, 3M researchers looked at both consumable and liquid process waste. Consumable waste corresponds to things like disposable bioreactor bags, product hold bags, and encapsulated filters. Liquid waste corresponds to processes like the pre-use flush volume of depth filters and chromatography columns. It is also worth noting, this particular study does not include liquid waste from cleaning, since the facility used to evaluate these metrics relies heavily on a single-use bioreactor and product hold bags. Even without cleaning waste, 3M single-use technologies still provided significant savings for the facility:
- Implementation of 3M Polisher ST resulted in a 5% decrease in the total consumable waste of the process, while 3M Harvest RC Chromatographic Clarifier resulted in a 21% reduction. Combining both technologies reduced the solid waste of the process by almost a quarter (Figure 2).
Figure 2: Total solid process waste of consumables per scenario
- 3M Polisher ST reduced the liquid process waste by 9%. The reduced flush on 3M™ Harvest RC Chromatographic Clarifier corresponds to a 4% lower liquid use. The combination of improvements in clarification and DSP resulted in a total water saving of 12% (Figure 3).
Figure 3: Total liquid process waste numbers per scenario
Click here to access the full whitepaper to explore the full methodology and findings of the study.
