February 15, 2011 (Vol. 31, No. 4)
Eric S. S. Langer President and Managing Partner BioPlan Associates
Many Would Like to See More Product Ideas and Innovations from the Cast of Suppliers
Biomanufacturers and CMOs are becoming increasingly vocal about the lack of new product innovation from their suppliers. But nowhere is that more painfully apparent than for single-use devices. In this year’s “8th Annual Report and Survey of Biomanufacturing Capacity and Production”, we asked over 300 global biomanufacturers to identify where they want vendors to focus their R&D efforts. Topping the list of nearly 25 key products were disposable/single-use devices (Table 1).
These responses may reflect both the growing acceptance of disposable/single-use devices, and the subsequent dissatisfaction with the existing state of product development. Nearly 39% of the industry wants more product innovation from their vendors.
Although respondents did not specify which “fixes” they are demanding, from other survey responses we believe much of the dissatisfaction centers around factors associated with design, including standardization, simplification of operations, and cost reduction.
Respondents said that improvements were needed in a number of areas, including: change-over and cleaning operations; product cross-contamination; campaign turnaround times; standardization; space requirements; sterility assurance; documentation requirements; bioreactor control; and reduction of bag breakage.
The kinds of innovation being demanded today may be less earth-shaking than incremental, small area developments, such as how these devices are actually used by operators, plug-n-play standardization, expanding to broader applications, or controlling how materials behave in actual use.
Wolfgang Noe from BPTC Consulting, believes that the real quantum leap will occur through process simplification, it is “not simply about replacing stainless steel with plastics, but about simplifying manufacturing technologies.” As single-use systems make the process more efficient and more idiot-proof, Noe believes that adoption will increase. Thus, to get beyond the current steady rate of adoption, innovation may hinge more on making production easier and more accessible to more people with fewer skills on a global perspective.
Creating simpler devices and processes will require standardization. As the industry has grown, so has the proliferation of unique designs and devices. Now, it is likely that substantial growth will need a more plug-n-play approach to managing product design and innovation. This kind of standardization will also permit greater efficiency and lower costs.
Drug companies continually seek ways to reduce costs, and speed drug development times, and disposables are playing an important role. For example, in this year’s study, 37.2% of biomanufacturers noted that over the past year, they used more single-use devices in manufacturing specifically to speed drug development time lines.
Similarly, we found that cost-cutting had a role in decisions for adopting disposables. This year, we found that, over the past 12 months, biomanufacturers addressed cost reduction in a wide variety of ways, but nearly 33% indicated they “accepted single-use systems into clinical manufacturing operations” specifically to reduce costs (a lower percentage indicated adoption at commercial-scale operations). Decision-makers are now focusing on how these devices can fit their needs. As such, product innovation, and utility will play a much larger role in adoption decisions.
“Single-use technologies have really entered prime time,” according to Paul Priebe, Sartorius Stedim Biotech’s director of fluid-management technologies for the Americas. “There is not a single process decision made today that does not consider single-use.” Priebe feels that there had been some irrational infatuation with this technology, but it is now just one option in their problem-solving tool kit.
As the industry advances, successful vendors will be listening more closely to customer needs. As with many newly introduced technologies, where end-users have not fully defined their needs, strong relationships between vendors and end-users are becoming critical for successful new product development.
Geoff Hodge, managing director of manufacturing services at Xcellerex, believes that the industry is at the point where the early adopters no longer have to strain to argue the benefits. Hodge says there is a need for “more integration of fully disposable facilities. To date, most single-use devices are used as a piecemeal afterthought to answer a quick need.”
Similarly, Jerold Martin, svp of global scientific affairs at Pall Life Sciences, points out that the industry consists of several submarkets, often with very different needs. “The industry has reached different degrees of implementation in the different submarkets,” Martin says. “Overall, the industry may still be considered quite young, but among smaller companies and CMOs single-use is gaining full acceptance because it enables these companies to produce clinical batches without much capital risk.”
Growth, Acceptance, and Restrictions
Comparing this year’s report data on industry growth to last year’s, we find remarkable stability in the problems the industry continues to face. This may suggest that vendors are doing little to resolve end-users’ top problems. We evaluated 13 areas of concern; the top four product-related reasons are shown in Table 2.
Growth and acceptance of disposables is clearly tied to the ability to meet end-users’ needs. There is now plenty of data available on these devices, and decision-makers have had enough time to evaluate single-use applications and models for their specific applications. So the engine for growth in this industry segment is more likely to be new product innovation that meets end-user needs.
Of course, the problem with new technologies in a regulated environment is that they are not quickly accepted by regulators without sufficient data from testing, or prior use. Thus, there is a built-in bias toward incremental improvements that don’t involve drug product contact. New, wider ranges of materials from which to manufacture single-use devices, and a better understanding of these materials will help ensure long-term growth in this industry segment. But this will require stamina and resources on the part of industry vendors.
Eric S. Langer ([email protected]) is managing partner at BioPlan Associates, publishers of the 8th Annual Report and Survey of Biopharmaceutical Manufacturing Capacity and Production.