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.