57.1% of Biomanufacturing Firms to Focus on Development of Single Use Systems in 2012
As manufacturers have increasingly sought new ways of reducing costs, the past few years have seen a rapid uptake of disposable technologies. Much of the inspiration stems from the single-use products that have been a common sight in hospitals for decades. But as interest in disposables rockets, a natural wave of concern has followed in its wake, with one of the main issues being the solid plastic waste generated by their use.
Why use disposable technologies?
A recent Pharma IQ survey, conducted ahead of the fourth annual Disposable Solutions for Biomanufacturing conference in February 2012, found that moving single-use systems from development into a commercial state is a main goal for 57.1 per cent of companies in the coming year.
The main reason for investing in disposable biomanufacturing systems is to make considerable efficiency gains. Many vendors, consultants and pharma companies are working hard to replace traditional facilities with single-use systems to improve flexibility and cost.
While at first it seems paradoxical to claim that disposable systems could have a smaller environmental footprint than conventional technologies, this is in fact being recognised by a growing number of organisations.
Single-use systems do not require the same intensive sanitisation efforts as more traditional technologies, allowing biomanufacturers to save on water, cleaning chemicals and energy.
But the plastic content of disposables means they come with their own set of environmental issues which biomanufacturing firms still need to overcome in order to run a sustainable operation.
According to the Pharma IQ survey of biomanufacturing professionals, almost a quarter of companies currently embrace single-use technologies for at least half of their biomanufacturing system.
The research shows that 21.4 per cent are using disposables in between 30 and 50 per cent of what they do, while just over a third have adopted single-use technologies for between ten and 30 per cent of their system.
Encouragingly, less than a quarter of firms have yet to deploy single-use solutions across fewer than one in ten systems, though none of the surveyed manufacturers used more than 75 per cent disposable technology.
When biomanufacturers were asked by Pharma IQ to disclose the stage of production at which the key challenges occur, the majority said downstream processes were most problematic.
Upstream biomanufacturing was said to present the biggest challenges for 35.7 per cent of participants in the study, while more than two thirds agreed that downstream processing is where most of the difficulty lies.
Aside from environmental impact and regulatory acceptance, two factors in product decisions throughout the pharmaceutical industry, there are several major challenges for biomanufacturers to overcome in terms of scaling up their systems for commercial use.
The Pharma IQ study found that choosing the right equipment in the first place is a primary concern for 42.9 per cent of users. Understanding the limitations of disposable equipment was shown to be a major headache for 35.7 per cent, while internal expertise was an issue for 7.1 per cent. Interestingly, just 21.4 per cent said validation of the system is the biggest challenge relating to scaling up systems for them, while an equal proportion said a fear of the unknown was their main reason for hesitation.
The most common methods for disposing of single-use technologies are landfill and incineration, which each come with their own environmental footprint, though incineration is widely considered the greener choice for sustainability in the long term.
In some instances, incineration can also result in the added bonus of energy savings made through cogeneration techniques. This usually entails a facility capturing energy generated from waste burning, before using it to produce heat or electricity.
But according to the Pharma IQ survey, a considerable proportion of biomanufacturing companies have yet to establish a clearly defined waste management strategy.
It found that while more than 71 per cent have strategies in place, almost 29 per cent have a way to go before a distinct waste management programme can be put into operation.
Delegates were also asked whether they use waste management services to dispose of single-use technologies. In this instance, 57.1 per cent answered positively while 28.6 per cent said they did not.
Other responses came from biomanufacturing firms that have adopted cogeneration techniques to make cost savings through sustainable use of energy produced by incineration.
Quality by design
In recent years, authorities such as the US Food and Drug Administration have made significant progress in implementing the concepts of Quality by Design (QbD) into their pre-market processes.
The concept is built upon the idea that quality should be integrated into a product with thorough understanding of the process by which it is developed and manufactured, as well as knowledge of the risks involved and how best to mitigate them.
Pharma IQ asked respondents to its survey whether their team had an established QbD programme in place. Just 21.4 per cent said they did. However, while 42.9 per cent of participants said they did not currently have a defined QbD strategy, 35.7 per cent said it actually depends on the product they are working on.
Disposable technologies in 2012
When Pharma IQ conducted its survey of biomanufacturing professionals, ahead of the fourth annual Disposable Solutions for Biomanufacturing conference in February 2012, respondents were quizzed as to what their main objectives would be in the year going forward.
Quite interestingly, 57.1 per cent of participants said moving single-use systems from development into commercial usage would be among their primary aims in 2012.
Moving into Asia was found to be the main goal for 21.4 per cent, while Russia was the geographical target for expansion cited by 7.1 per cent of respondents.
Finally, establishing a quality assessment strategy for disposable equipment was named a primary objective for 2012 by 21.4 per cent of biomanufacturers and risk mitigation the top priority for 14.3 per cent.