October 15, 2017 (Vol. 37, No. 18)
Lab Automation through Single-Use Sensors and Monitors
Bioreactors tend to sparge high volumes of gas, which can pose a problem for single-use bioreactors. If that gas clogs the vent filters, the system can overpressurize and burst. The solution is to add pressure sensors to bioreactors. By doing so, operators can measure the performance of gas handling and clear clogs before they pose a hazard.
That realization netted instant sales of single-use pressure sensors for PendoTECH in 2007 (two years after the company formed) thanks to the increasing popularity of single-use stirred-tank bioreactors. Pharmaceutical manufacturing faces those same challenges today.
Two Main Product Areas
Since those fledgling days, PendoTECH has developed two broad product areas: single-use sensors and monitors, and lab process-automation systems.
“Single-use sensors and monitors are simple devices,” says Jim Furey, founder, and general manager. “Plug a sensor into a monitor, get a reading, and throw away the sensor. No data are stored on the sensors, so data recording isn’t an issue. Some of the monitors include communications capabilities to link to a controller.”
PendoTECH’s lab process-automation systems apply to purification, normal flow filtration, tangential-flow filtration, and many other processes to help with scale up. For example, “before companies go to large batches, they have a syringe filter they use for scale up. Our normal flow filter screening system performs four studies in parallel to determine filter capacity and collect data,” he says.
The company’s sensor customers are, increasingly, original equipment manufacturers (OEMs). “Their initial debate,” Furey says, “was whether to build or buy their sensors. Initially, many OEMs built their own, but as markets grew, they realized in-house sensors had limited market potential.” OEMs turned to others to fill that niche. PendoTECH, as an early developer, sells a high percentage of its sensors and monitors to OEMs for GMP production, clinical batches, and pilot and toxicology studies.
“We’ve designed more sensor sizes over the years so the sensors can fit on a wider range of tubes. We’ve also introduced molded sensors with sanitary flanges so that they can clamp to filters,” he says.
PendoTECH’s lab automation off-the-shelf solutions allow custom configuration of the system with industry standard pumps and scales, all interfaced to a PC-based graphical user interface (GUI). “Our OPC server that is built into our GUIs, for example, lets customers capture data in a high-level data historian,” which captures data from all lab users’ instruments. Users can grab data in real time from the historian without needing to access multiple users’ laptops.
Currently, “We’re working on an app to view sensor data on smart devices, so people can see process data on a tablet or phone in real time, regardless where they are,” Furey says. The app will work with all four PendoTECH systems. The first release of this as-yet-unnamed app is planned for 2018.
Customer Challenges Drive Innovation
Innovation at PendoTECH often has evolved from solving specific customers’ challenges. “We try to roll suggestions into existing or new products. We have a database of customer requests for new features, which we review quarterly and when updating products. That leads to new sizes and features, like the new molds and sizes for a new pressure sensor.” For example, the 1/8” sensors the company just launched emanated from a customer request for a sensor that fit the small tubing used for cell-therapy processing. “UV absorbance and temperature sensors are rolling out now with that size,” Furey says.
To try PendoTECH’s solutions, end-users should contact the company’s tech support engineers or applications engineers. “From there, we have demonstration equipment people can evaluate at no charge.” If they like the sensors, end-users should ask their OEMs to add them to their solutions or contact PendoTECH directly. “On the control systems, we deal directly with end-users. Once they purchase our product, we’ll do all the setup and training.”
Free Updates…If You Know to Ask
What most people don’t realize is that they can get PendoTECH’s software updates at no charge. “Users are entitled to the latest versions, although we strive to maintain backwards compatibility,” Furey says. “To get our software updates, users need to contact PendoTECH to get the link to the download site.”
PendoTECH, unfortunately, lacks a way to push software updates out to its users or to alert them to updates. “Large companies may have 15 of our lab automation systems and just as many users. There’s no way to update all the systems at once and no effective way to alert users to updates,” he says. “Newsletters have open rates of 10–15%. We went back a few years to track users, but many have moved to other positions or don’t respond.”
That situation seems not to have slowed company growth. That was caused by the recession of 2008–2009.
Disposables Trend Created Opportunity
Around 2004–2005, single-use technology was trending, which reduced process-system complexity by eliminating the need to clean- or steam-in-place. “We were looking at gaps in the market, focused on single-use applications,” Furey recalls. Initially, the company focused on single-use technology implementation consulting, but soon moved to the development of single-use pressure sensors. Early customers included Thermo Fisher Scientific and Xcellerex (now a part of GE).
To provide a steady, early, revenue stream, the company also provided consulting for single-use implementation. A contract with Bristol-Myers Squibb provided a major boost. “But, it’s hard to consult and have your own products to recommend,” Furey points out. He closed the consultancy to focus on product development.
By 2008, the company was coming together, and sales were growing. Then, toward the end of the year, “Sales stopped. Cash flow stopped. In fact, everything seemed to stop,” Furey recalls. The United States entered one of its worst recessions since the Great Depression. At that point, “We got some leveraged financing from some key suppliers who stretched out our payments because they believed in what we were doing. We also sought knowledgeable angel investors who could supply ad hoc advice. They’re still shareholders.”
In 2010, the economy began to rebound and, with it, PendoTECH. He says average growth rates have exceeded 30% each year since then. That growth is the direct result of strong customer relationships. “You listen to them, and they come back. Regular communication leads to continuous improvement that makes products more valuable. We’re challenged by customers, and they’re willing to try things,” Furey says.
Soon, one of those innovations may be a conductivity and temperature sensor. “We’re looking to place one on the outside wall of storage bags to measure bag contents,” Furey states. Adding that the major OEMs—who would actually affix the sensor—support the idea.
PendoTECH’s future will be rooted strongly in its past. As bioprocessing grows globally, the need for innovative solutions also will grow. The company is positioning itself to respond, by listening closely to its customers. New geographical markets will be part of that future. “We’re looking to grow a stronger presence in Asia,” Furey says.
Location: 174 Nassau Street, Suite 256, Princeton, NJ 08542
Principal: Jim Furey, Founder and General Manager
Number of Employees: Confidential
Focus: PendoTECH develops a range of sensors and lab automation systems for bioprocess controls for the biotech and biopharmaceutical industry.