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“Changes in lifestyles and healthcare systems, and increasing demand for drugs at reduced prices, has led to the development of facilities that can produce more than one product, offering flexibility and scalability.” (4) Single use systems , which are utilized within upstream and downstream processing, can simplify the path to market via the reduction of sterilisation time , swifter set up times, lower cross contamination levels and lower operating costs.

According to a recent study, the global single use technology biopharmaceutical market reached $1.7 billion in 2014, a $0.3 billion jump from the year prior. Looking at the period of 2014 – 2019, the market is predicted to expand at an compound annual growth rate of 11.7 per cent to almost $3 billion. (4)

The US market is expected to increase to $1.1 billion by 2019 from 2014’s $573 million. However, Europe is expected to grow at a slightly slower pace, from $599m in 2014 to $1 billion in 2019.

The acceptance of single use tech is said to have spurred the growth of other industries including global membrane technology market.

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Industry Standards

The issue of standardization in the single use technologies market and has been the focus of industry discussion in regards to system designs, build, safety and testing standards. Many marked the lack of standardization as a key roadblock to industry wide adoption.

In regards to regulation, the recent publication of the long awaited PDA technical report, marked a milestone in progression for industry standardisation.

Another barrier to adoption for single use technologies alongside bag breakage is extractable and leachables. In fact, extractables and leachables are marked as the biggest roadblock for the single use market.

Industry experts have noted that a stronger more cohesive standpoint on a macro scale is needed on testing and operating standards with extractables and leachables – namely being sourced from relevant regulators and trade bodies. Theories suggest that only then will performance gaps disappear and confidence in single use systems rise.

A standardized approach promotes the direct comparison between single use components, allowing suppliers and pharma firms to use extractable data to control polymer quality. Although, accessed by some SUS suppliers and end users through implementation, to date extractables study design resultant data from industry circles such as Bio-Process Systems Alliance (BPSA) and BioPhorum Operations Group (BPOG) has not been publically available to the industry at large.

Now, an improvement in the current patchwork level of understanding is said to be on the horizon.

Earlier this year Chemic Laboratories Inc. declared its corporate commitment to generate analytical data on the BOSA and BPOG study designs and independently assess proposed extractables methodologies. The data is scheduled to be available to the public within this quarter.

A number of industry sources maintain that over the last few years single use systems have gained more widespread acceptance within biomanufacturing.

New design

The single use market has seen a wave of new developments in regards to capabilities and functionality.

This includes a heightened level of sophistication within single use technologies in upstream and downstream bioprocess steps.

Some of the disruptive design advancements within single use systems include, Sartorius’s FlexAct BP.

Aimed at improving process efficiency and speed, Sartorius’s FlexAct BP buffer prep central operating system allows users to custom- configure single use systems within bio manufacturing processes.

Also, Pall Corp’s Allegro 3D bio-containers to tackle contamination. single-use bio reactors for microbial fermentations, rigid-wall stirred tank bio reactors and single use sensors. As well as improved functionalities such as control systems and feed methods.

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Resources

1. http://www.pbsbiotech.com/uploads/1/7/9/9/17996975/contract-pharma-single-use-trends-april-2010.pdf

2 http://www.disposablebiomanufacturing.com/media/1001607/36896.pdf

3 http://www.processdevelopmentforum.com/articles/trends-in-single-use-bioreactors/

4 http://www.prnewswire.com/news-releases/single-use-technologies-for-biopharmaceuticals-global-markets-300111090.html

5 http://www.pharmaasia.com/article/ssb-launches-single-use-harvesting-tech-for-high-cell-density-cultures/11564 - single cell tech

6 http://rentschler.de/uploads/media/Manufacturing_Chemist_15-16_OCT_MCF_PDF_for_Publication_01.pdf

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