The demand for improvements in single use, disposable bioprocessing equipment have shot to the top of end-users’ wish list of better, more innovative products in 2011. And the industry’s push for better single use purification devices leads the pack with almost 40% of our 352 survey respondents this year looking for better downstream single use products.  The data, released in BioPlan Associates' 8th Annual Report and Survey of Biopharmaceutical Manufacturing Capacity and Production, points to an increasing concern that innovations in disposable bioprocessing products have been slow to appear. Our annual global study, which had responses from biomanufacturers in 31 countries, identified many ‘problems in need of solutions.’
We asked respondents to identify their top areas where suppliers should focus their development efforts. Among the 21 most commonly cited areas, improved single use/disposable products led, with four of the top six areas. Single use purification products, probes/sensors and bags/liners, connectors, and bioreactors were among the contenders for the next new biomanufacturing products. We found, for example, that 29% of the industry desired improvements in bioreactors, generally one of the largest bioprocessing expenses. The type of bioreactors also largely determines other up- and down-stream equipment selections. In comparison to disposable equipment, only 6% indicated a desire for improvements in fixed stainless steel bioprocessing equipment.
Figure 1: Selected New Product Development Focus Areas, Where Suppliers Must Focus Development Efforts, 2011
Source: 8th Annual Report and Survey of Biopharmaceutical Manufacturing, April 2011, BioPlan Associates, Inc. www.bioplanassociates.com
We also evaluated the trend in demands for new products from vendors, and found some significant shifts. Interest in better innovation in disposable, single-use devices for measuring and monitoring (probes, sensors, etc) jumped from 29.3% of respondents in 2010 to 37.0% this year. Relatively few of these products are currently available and there are often issues regarding ports and how to pass disposable sensors through bioreactors and other vessels and their bag liners. Meanwhile, improved disposable purification products, which led all areas this year at 37.9% of respondents, showed modest growth from last year’s 34.9%. While this was the area where users most desired improved single-use products, the result was not a surprise. Improvements in upstream manufacturing have greatly enhanced yields in recent years, largely as a result of improved cell lines and expression systems. However, downstream purification processes have scarcely changed and are increasingly the limiting factor in commercial-scale biopharmaceutical manufacture. Also, purification, including chromatography columns and media, with different steps and equipment, can be time-consuming and expensive.
Interest in disposable bags, connectors, and other such products modestly decreased from 2010 (36.5% this year, compared to 38.9% in 2010), but remains high on the list of desired innovations. Possible innovations such as unitary (single-piece) molded plastic bioreactors could offer advantages, including in performance and reduced costs, over adding expensive plastic bags/liners to expensive stainless steel bioreactors and other containers. However, the predominant single-use paradigm continues to be adding multi-layer plastic laminate bags/ liners to what are essentially classic-design stainless steel bioreactors, mixers and other fluid containers. Many of the key vendors are committed to this approach, and some have recently invested in costly bag-making manufacturing facilities. These companies will be dedicated to current product lines and this paradigm for years to come. The problem with this approach, along with a host of other current single-use equipment designs, is that they curb opportunities for innovation and new product introductions. Once initiated, vendors are effectively unable to significantly upgrade existing product lines. Furthermore, incremental product upgrades risk seriously distressing their existing customers, particularly if current products are phased out. Indeed, bioprocessing product changes require considerable expense and work, including modification of regulatory filings, SOPs and training, and perhaps most discouragingly, potentially requiring another round of validation testing. The approximately $100,000 price tag for testing of devices with significant product contact (required for approvals) stands as a major deterrent.
Interest in assays grew significantly this year, from 24.5% of respondents in 2010 to 31.1%, in line with a trend expectation from the industry, which sees more and more automated assays being implemented to achieve higher quality and consistency. However, some of last year’s key new product areas declined in interest among respondents. These include: chromatography products (37% down to 30%) and process development, both downstream and upstream (35% to 27% and 25% to 19%, respectively). This lessening of concern for new bioreactor products may be related to the emergence of some interesting innovations, which have sparked recognitions such as PBS Biotech’s recent honoring as Business of the Year by Pacific Coast Business Times. In particular, small scale single use bioreactors, with traditional impeller designs like NBS or Millipore’s, have begun to fill some of the gaps in the disposable bioreactor market. This is an example whereby the available “bag design” bioreactors did not meet customers’ needs, and a creative alternative emerged. In some business models and specific situations, small scale bioreactors will replace bag design. Even so, according to Robert Repetto, Director of Technology and Innovation at Pfizer, “it will not revolutionize the bioreactor market, as its scope is too limited to be disruptive to the industry.”