Wireless technologies have flourished and are transforming the way that manufacturers in all industries monitor their operations. It’s happening in biopharma, and consultant Larry West, principal at Aspen Brook Consulting, is watching intently and working with biologics manufacturers like Amgen and Genentech to move into the wireless era. Interestingly, West says, wireless technologies are having more of an impact outside the manufacturing space (via smart phones and laptops) than they are inside (via wireless sensors, transmitters, and receivers).
The most intriguing question, of course, is whether manufacturers and regulators will be able to make the leap—of technology and faith—from wireless monitoring to performing actual process control activities by wireless means.
We spoke with West about where wireless will lead biopharma in the coming years.
PhM: Where is biopharma now in terms of using wireless technologies for process monitoring? In what areas is it having success?
L.W.: The challenge for wireless in the bioprocess management environment is that, but for a few exceptions, the facilities are completely unlike those common to other industries. As such, the often quoted arguments for wireless such as savings from reduced conduit runs and EH&S concerns do not have nearly as much merit in our industry as they might enjoy in, say, the petrochemical industry. Couple that with the fact that the volume of potential wireless solutions lies not with pilot or manufacturing applications but instead with process development, and you have a real challenge. This challenge arises from the fact that most elements of process development are designed with the idea of reducing footprint, yet most of today’s wireless offerings do anything but reduce a footprint. That being the case, most wireless vendors are focused on the far less numerous but more application-friendly pilot and manufacturing applications. For these applications (recognizing the limitations of their traditional arguments mentioned above), wireless vendors have chosen to emphasize improved performance of wireless devices over traditional analog devices.
Having said that, it is important to define “wireless” as it relates specifically to the bioprocess management industry. For our purposes, wireless is not represented so much by, for example, a wireless pH transmitter with its NEMA 4X housing. Instead, it is seen more as the wireless associated with devices such as smart phones, pads and laptops. For these devices and their implementation of wireless, the applications in bioprocess management span process development, pilot, manufacturing, and well beyond.
PhM: You work with industry leaders in biotech and pharma. What can you share about their current initiatives in wireless? Where are they pushing the envelope?
L.W.: There is a great deal of interest on the part of small and large manufacturers alike in the role wireless can play in the management of their bioprocess. While in some more limited instances, this interest is in wireless enabled instruments such as transmitters, far greater interest today lies with wireless enabled devices such as smart phones, pads and laptops. For most of these companies, deployment of these resources is relatively quick and inexpensive due in large part to the web enabled nature of many of their legacy control systems, enterprise historians, skid-based and benchtop control solutions. Less than five years ago, pushing the envelope meant having an IP address assigned to your process control system so as to allow you to view bioprocess data from your office PC. Today, companies such as Transpara and DASGIP are offering solutions that place all of your critical bioprocess data, complete with alarms and trending, in near real-time on your smart device. An example of pushing the envelope today would be Genentech in South San Francisco, which has deployed the Transpara solution.
One senior engineer at Genentech has told me, “I was at the base camp of Mt. Everest, and with my Blackberry, I was able to check the pH of one of my bioreactors.”
PhM: Are there other manufacturers that you know of with intriguing implementations?
L.W.: To be honest, the ever-increasing deployment of solutions such as smart devices is having the effect of dramatically raising the bar for one to be considered “intriguing.” However, perhaps the most intriguing I have seen recently was at Interphex in New York earlier this year. It was there that I saw a bioprocess analyzer from Nova Biomedical interconnected wirelessly to a bioreactor control system from DASGIP. The impressive part was that the Nova, which itself is capable of generating more than a dozen critical bioprocess values, was wirelessly sharing its bioprocess data with DASGIP, which was then re-transmitting said data—accompanied by all other critical bioprocess data associated with the bioreactor—to a remote Apple iPad device on which a person could monitor their bioprocess.
PhM: How do you rate the technologies (hardware and software) that are out there? Are there technology gaps that are preventing biomanufacturers from implementing comprehensive wireless solutions?
L.W.: On the subject of wireless enabled devices such as smart phones, pads and laptops, I have found their processing power, reliability and price point to be excellent for monitoring applications in bioprocess management. Now this is not to say that I do not believe wireless enabled instruments will not someday be on par with these solutions. However, seeing as we are just now experiencing widespread adoption of the OPC protocol in bioprocess management, and this adoption is building bridges of communication to previously isolated analog instruments, and that the resulting data can today be communicated wirelessly by means of proven devices such as smart phones and so on, I’m not confident that the bioprocess management industry is going to be clamoring for a 7-pound, pipe-mounted, NEMA 4X pH transmitter anytime soon. And keep in mind, there are more than fifty process variables measured and/or controlled in a modest upstream bioprocess, yet as few as five of these variables are represented by a wireless transmitter solution today.
PhM: What’s the latest on wireless standards, and are they an issue that’s still holding some end users back?
L.W.: As recently as five years ago, a discussion of wireless would, if serious, delve into a discussion of frequencies, ranges, and the like. In fact, for a period of time it was not uncommon to be asked if a facility’s fluorescent lighting was compliant with a wireless installation, as it was believed certain such lighting interfered with wireless signals. Today, aggressive development on the part of Emerson, Honeywell and others in partnership with recognized wireless experts such as Cisco, and a healthy amount of associated marketing, have gone a long way to addressing such concerns. Of course, concerns such as wireless standards give way to the far more common concerns about network bandwidth, licensing, security and the like in the more common of applications of wireless having to do with smart phones, pads and dashboard-enabled laptops.
PhM: What’s driving the adoption of these smart devices?
L.W.: It is being driven largely by two factors: the first being that the nature of bioprocess management is a 24/7 process, and the second that it is a knowledge-centric process. That is to say that, although there are a number of persons involved in the process, there are but a few with the depth of knowledge needed to make certain critical process decisions. As such, deploying wireless-enabled devices such as smart phones, pads, laptops and the like enable several of these knowledge-centric resources to be available even when personnel are far removed from the process—such as in meetings, at home or employed at a sister site across the globe. In fact, it has become an indication of one’s status in the bioprocess management hierarchy to have a company-issued smart phone or dashboard display on a laptop enabled with bioprocess monitoring.
PhM: Wireless control of processes is somewhat of a holy grail, but obviously there are concerns. What’s the comfort level of the industry with this idea, and what are the main issues of concern from a technology or implementation standpoint?
L.W.: To date, industry acceptance of process monitoring by means of a wireless interface has gained ever-increasing acceptance. However, when this conversation turns to a transition from monitoring to control, the acceptance all but vanishes. In the early years of the technology, the question was one of perceived reliability. The increasing role of wireless in our daily lives has helped to reduce reliability concerns while at the same time introducing a brand new concern, security. As recently as five years ago, a conversation on wireless networks in bioprocessing would inevitably lead to a discussion of data security and the perceived ability of a competitor to sit in the parking lot and “see” critical process data. While improvements in wireless security over the years have addressed a majority of these concerns, there remains a healthy measure of suspicion on the part of corporate IT groups about data security. Couple this with concerns about regulatory compliance in validated environments, and you have perhaps the two greatest hurdles facing industry adoption of wireless-based methodologies for process control.
PhM: How about concerns from a regulatory standpoint? Is FDA open to the idea of wireless process control?
L.W.: To demonstrate its support for the emerging role of wireless technology, the FDA teamed with the FCC in 2010, the stated purpose of which being to promote development and deployment of wireless technologies. However, when it comes to the role of wireless technology in process control applications, regulatory agencies such as the FDA in the U.S. and EMA in Europe have yet to take a more formal public position. Perhaps the closest our industry has seen to such a formal public position by either regulatory agency is their continued support of the Process Analytical Technologies (PAT) initiative and the more recent QbD guidance.
About the Interview Subject
Larry West is a Principal at Aspen Brook Consulting with 20+ years of experience in Sales, Marketing, Product and Business Development specific to the bioprocess management market. He has held executive management positions for industry leading suppliers of bioprocess management hardware, software and services solutions. Mr. West is the named inventor of the DeltaV enabled BioNet Bioprocess Control System, frequent author and speaker on the subject of bioprocess measurement, control, and automation.
