Genetic Engineering & Biotechnology News

OCT15 2017

Genetic Engineering & Biotechnology News (GEN) is the world's most widely read biotech publication. It provides the R&D community with critical information on the tools, technologies, and trends that drive the biotech industry.

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6 | OCTOBER 15, 2017 | | Genetic Engineering & Biotechnology News Gail Dutton 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 biore- actors. 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. Phar- maceutical 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 capabili- ties to link to a controller." PendoTECH's lab process-automation systems apply to purification, normal flow fil- tration, tangential-flow filtration, and many other processes to help with scale up. For ex- ample, "before companies go to large batch- es, 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, in- creasingly, 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 mold- ed 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 exam- ple, lets customers capture data in a high-lev- el 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 Pendo- TECH 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' chal- lenges. "We try to roll suggestions into exist- ing or new products. We have a database of customer requests for new features, which we review quarterly and when updating prod- ucts. That leads to new sizes and features, like the new molds and sizes for a new pres- sure 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 con- tact 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 Lab Automation through Single-Use Sensors and Monitors Bioprocess Control Specialist Focuses on Single-Use Sensors Corporate Profile PendoTECH delivers a line of pressure sensors, control systems, and software to manage bioprocess applications. For example, the company's PressureMAT system incorporates a single-use pressure sensor and an LCD screen that displays pressure readings. As shown in this image, the system can send readings to a PC or control system for data collection. Insights Industry Watch Amgen and Allergan have won the first U.S. approval for a cancer biosimilar following FDA authorization of Mvasi ™ (bevacizumab-awwb), a near-copy of Roche subsidiary Genentech's Avastin (bevacizumab). Mvasi has been approved for adults with specific forms of colorectal, lung, brain, kidney and cervical cancers. Just when Mvasi will reach the market—and its cost—remain unknown. Avastin retains U.S. patent exclusivity until 2019— patents that earlier this year were at the center of a legal wrangle between Amgen and Genentech. Amgen is not discussing Mvasi's launch date or pricing, but is providing application and manufacturing information to Genentech, as required by the Biologics Price Com- petition and Innovation Act. In February 2017, Genentech sued Amgen, contend- ing that Amgen violated the Biologics Price Competition and Innovation Act, specifically, the information disclo- sure requirements related to patent disputes. A federal judge dismissed Genentech's complaint "without preju- dice," allowing for refiling within 45 days. A unanimous High Court sided with biosimilars developers. Genentech spokeswoman Meghan Cox told GEN the company won't discuss its dispute with Amgen. Mvasi adds to competitive pressures on Genentech and Roche. During the first half of 2017, Roche's sales of Avastin dipped 1% to CHF 3.405 billion ($3.55 billion). Roche is relying on sales overseas, especially in China, saying its U.S. sales decline is "largely due to growing use of cancer immunotherapy medicines in lung cancer." Amgen, in contrast, has 10 biosimilar programs in the pipeline, including four oncology biosimilars that are being codeveloped with Allergan. Mvasi is the seventh biosimilar approved by the FDA, which expressed hope in a press release that its action would lower prices for new cancer treatments. Several Avastin biosimilar candidates are in Phase III, including Biocad's BCD-021, Biocon's biosimilar to bevacizumab; Boehringer Ingelheim's BI695502; IBC Generium/Affitech's GNR-011 (Phase II/III); Kyowa Hakko Kirin's FKB238; Pfizer's PF-06439535; and Samsung Bioepis' SB8. "It usually takes more than one competitor to have a major impact on price, and that will even be more [true] for biosimilars, since they are complicated to make and will have higher prices to begin with," Brad Loncar, CEO of Loncar Investments, told GEN. n Approved Amgen-Allergan Biosimilar Fuels Competitive Pressures for Roche, Genentech

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