disposable processing

Key areas driving demand for single-use applications

Single-use applications continue to dominate the list of innovation areas sought by the biopharmaceutical manufacturing community, a testament to the widespread optimism surrounding the benefits of their use. However, with disposable applications having already broadly penetrated earlier-stage manufacturing and making headway into commercial stages, the focus is more on implementation and integration of these devices than on their further development in terms of innovation.

For example, in our annual survey of biomanufacturers this year, we asked respondents to identify the single most important biomanufacturing trend or operational area on which the industry must focus its efforts. Respondents were more than twice as likely to point to the actual implementation of single-use devices as to cite a general need for better SUS products. Essentially, bottlenecks are now arising from how to insert these no-longer-novel devices into existing bioprocesses.

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As this trend expands, biomanufacturers can expect to see increasing benefits from successful implementation. Results from our global study – 12th Annual Report and Survey of Biopharmaceutical Manufacturing Capacity and Production [1] – offer insights as to the areas of potential benefit that are driving demand for single-use implementation.

Our study asks respondents to identify various reasons for increasing their use of disposables as either “important” or “very important,” and identifies trends in these responses over several years. For the purposes of this article, we’ll examine either key factors or growing ones, over the course of this decade (from 2011 onwards).

Data Source: 12th Annual Report and Survey of Biopharmaceutical Manufacturing, April 2015, www.bioplanassociates.com/12th

1. Decreasing risk of product cross-contamination

Over the past 5 years, biomanufacturers have become increasingly attuned to the ability for single-use devices to decrease the risk of product cross-contamination. In fact, in this year’s study, this was considered a “very important” reason for increasing use of disposable systems by the largest share of respondents (50%). By comparison, back in 2011, it was the third-most cited “very important” attribute.

This is a benefit that is felt more strongly by contract manufacturing organizations (CMOs) than biotherapeutic developers, with CMOs almost 50% more likely to feel that this is a very important reason for increasing disposables use. This is likely due to the CMO business model, which often involves dealing with multiple product lines and rapid changeovers.

CMOs may also be responding to client concerns when it comes to cross contamination. One of the fastest-growing considerations we’ve observed in our study when it comes to CMO selection is the CMO’s ability to effectively handle cross-contamination issues. Over the past decade this has been the second-fastest growing critical selection attribute considered by clients. With that in mind, CMOs are right to see this benefit as an attractive proposition presented by disposable application use.

2. Reduce time to get facility up and running

Almost half of the biomanufacturers we surveyed for our report consider the reduction in time spent to get a facility running to be a very important reason for increasing their use of disposables. And while slightly fewer feel that the reduction of capital investments is a very important reason, our study reveals that this is in fact the single most critical reason driving further adoption of single-use devices.

3. Reduce capital investment in facility and equipment

These twin approaches – that shorten the time to get facilities up and running and reduce the capital investments involved – are becoming necessary for new facilities. As the biopharmaceutical industry shifts from a blockbuster sales model to more targeted therapeutics, the need to avoid costly investments in sizable stainless steel equipment is increasing.

The use of single-use bioprocessing equipment is making product manufacture increasingly efficient and frequently less costly, particularly for early stages such as R&D and clinical trials. This is particularly important for smaller and lesser-funded companies, for whom using single-use equipment for in-house candidate product manufacture is one of the only viable options (aside from outsourcing). While single-use equipment comes with its own costs - including the continued costs of replacing the applications - smaller companies can avoid the $50-$150 million facility price tag for construction of fixed, dedicated stainless steel bioreactor-based bioprocessing systems.

4. Flexibility of a “modular” approach

Perhaps one of the biggest future trends in the biomanufacturing industry is the move toward “modular” facilities. We believe that this may be the next phase in the bioprocessing evolution, particularly for pre-commercial manufacturing, as manufacturing becomes more modular or otherwise increasingly compartmentalizes and seals unit process equipment.

A more modular approach promises many of the same benefits already ascribed to single-use devices, such as the reduction of contamination risks, costs, and time to get a facility up and running. Construction of new facilities can be completed in weeks or even days – even for commercial manufacture. Modular facilities work hand-in-hand with single-use applications; companies will essentially be able to assemble bioprocessing systems using modules ready for plug-and-play with other modules. This is also likely a reason for the increasing focus on single-use connectivity noted elsewhere in our study. Indeed, the companies that have spearheaded modular bioprocessing units, such as GE and G-Con, are developing units that are basically single-use equipment installed within a portable self-enclosed trailer or other deliverable room-sized cleanroom.

As such, the adoption and increasing expertise in using disposable applications can open manufacturers up to more flexibility than otherwise afforded by traditional stainless steel equipment. While this flexibility has not increased as a very important single-use attribute in the past couple of years, signs point to this becoming more critical over time.

5. Ease of control of bioreactors

Although this is not a top reason for using disposable applications, biomanufacturers have in the past few years increasingly recognized that single-use equipment (such as the use of probes) can result in improved control of bioreactors. This may be driving demand for better disposable probes and sensors, which are consistently at the top of the list of new product development areas on which the industry wants suppliers to focus.

Tightly controlled bioreactor operations should only grow as the technology continues to advance with the implementation of more real-time process monitoring applications, and manufacturers should keep this in mind as they weigh the benefits of moving to disposable applications.

Conclusion

Our study suggests that of the benefits to successful implementation of single-use devices, some continue to grow in relevance. Some have been consistently near the top of the agenda for several years, such as the elimination of cost-cutting mechanisms and the reduction of time and capital investments. Others, such as ease of bioreactor control and the flexibility afforded for a more modular approach, may come more into focus and could well become critically important factors in the years to come.

References :

1. 12th Annual Report and Survey of Biopharmaceutical Manufacturing Capacity and Production, April 2015, Rockville, MD www.bioplanassociates.com/12th

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