Evaluating Disposable Mixing Systems - Drug manufacturers should follow a risk-assessment methodology when selecting a single-use mixing system for product development. - BioPharm International

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Evaluating Disposable Mixing Systems
Drug manufacturers should follow a risk-assessment methodology when selecting a single-use mixing system for product development.


BioPharm International
Volume 22, Issue 2

Non-Technical Issues Raised

As disposable technologies start to play an active role in the process and become more integrated into manufacturing, factors such as cost, testing, and supply-chain security become as important as the technologies' capabilities. Below are some specific comments made during the interviews.

Cost. In our work with users evaluating mixing technologies, we have seen situations where the proposed mixing technologies are more expensive in terms of upfront capital costs and operating costs. This is linked to the application and the actual technology being considered. In this situation, operational and other benefits have to be identified and it may be that the stainless-steel option is the most sensible.

Testing. Testing the integrity of a system before use in critical application is an issue for both stainless-steel and disposable systems. Some companies also expressed reticence to use disposable mixing technology from any supplier for later-stage downstream processing applications such as bulk product formulation because of the current unavailability of a post-integrity test system on the disposable-bag systems themselves.

Supply chain. A concern for all users is security of supply and in the case of unique mixing systems, the single sourcing of the mixer is of concern and has to be managed. From the supplier side, ATMI appears to be addressing this concern through the outlicensing of their technologies to other suppliers such as Sartorius Stedim Biotech. The end-users have reacted favorably to this approach because it opens up avenues to obtaining the same technology from two suppliers, thereby reducing supply-chain risk.

SUPPLIER'S PERSPECTIVE

Having spoken to a number of users, we wanted to get the suppliers' perspective. ATMI has the widest range of mixing technologies currently, and therefore, we wanted to get their perspective on the market and ATMI's approach. Miriam Monge (MM) spoke with Mario Philips (MP), managing director of ATMI Packaging. The following are excerpts from the interview:

MM: What was the driver for ATMI focussing specifically on the disposable mixing market segment?

MP: The driver for ATMI focussing on disposable mixing systems came out of our Six Sigma approach that involved a voice of the customer process. A market study was carried out in 2004, to establish what the key needs of the end-users in disposables were. The clear message that came out of this study was the need for disposable mixing solutions. A Pareto analysis was subsequently carried out to establish the 10 criteria that the technology had to meet in order of their importance. The top three criteria were 1) scalability, 2) powder–solid mixing capabilities for up to a 60% solid concentration, and 3) one product contact material from small scale to large scale.

MM: What do you see as the main value-added features that we will see in mixing systems moving forward?

MP: Mixing systems are increasingly used for virus inactivation, in which pH and conductivity measurements are required. As such, reliable sensor systems are required. Currently, conventional sensor systems are used, but as the disposable sensor technology matures, this will bring added value to the end-user base.

MM: What do you see as the main barrier to entry for disposable systems? We have heard end-users voice concerns with regards to supply-chain security.

MP: As ATMI saw previously in the semiconductor industry, there is a clear need for standardization, with, for example, different suppliers working with similar film formulations. Our vision is that there is little value in the film itself—the suppliers should agree on a standard so as to facilitate contingency of supply, which is the end-users' primary concern. Customers need a dual sourcing strategy. It is the technologies themselves that bring value to the customers, not the film. The fact that each supplier has developed different film formulations represents a validation nightmare for the end-users.

MM: How do you see the level of market acceptance of disposable mixing systems? Has this evolved?

MP: This is somewhat company dependent in terms of the level of maturity of the given company working with disposable technologies. For disposable mixing systems, we do see a move away from local decision-making in many companies to a global decision-making approach. There is now certainly far more technical benchmarking of the different mixing technologies available and all the companies taking this global decision-making approach have defined that they must validate two mixing technologies.

SUMMARY

There are many disposable mixing technologies available from a range of vendor. Some of this variety is in response to the differing applications but much of it reflects the novelty of the technology in this application. It is clear from our discussions with end users that progress is being made in terms of vendors supplying effective technologies, but the total disposable mixing technology offering is relatively immature and carries with it an inherent supply-chain risk. Also, from the technical point of view, no one system is considered optimal.

A number of users have indicated that they were holding off on making decisions to move forward with disposable mixing systems because of three reasons: supply-chain insecurity, technology immaturity, and uncertainty as to whether the technology was really going to be cost effective, particularly for larger-scale media and buffer preparation applications. So the challenges remain and as the interview with Mario Phillips shows, the suppliers are listening and the eventual winners will be those that address not only the technical solutions but also the cost and supply-chain security issues.

Andrew Sinclair is the managing director and Miriam Monge is the vice president of marketing and disposables implementation, both at Biopharm Services, Chesham, Bucks, UK, +44 1494 793 243,
Miriam is also the European chair of ISPE's Community of Practice for Disposable Technologies.


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