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BIO INNOVATION NOTES REPORT 22 LIFESCIENCELEADER.COM JUNE 2014 Survey Methodology: The 2014 Eleventh Annual Report and Survey of Biopharmaceutical Manufacturing Capacity and Production yields a composite view and trend analysis from 238 responsible individuals at biopharmaceutical manufac- turers and contract manufacturing organizations (CMOs) in 31 countries. The methodology also included over 173 direct suppliers of materials, services, and equipment to this industry. This year's study covers such issues as: new product needs, facility budget changes, current capacity, future capacity constraints, expansions, use of disposables, trends and budgets in disposables, trends in downstream purifi cation, quality management and control, hiring issues, and employment. The quantitative trend analysis provides details and comparisons of production by biotherapeutic developers and CMOs. It also evaluates trends over time, and assesses differences in the world's major markets in the U.S. and Europe. TYPES OF SENSORS IN DEMAND ARE CHANGING While simple sensors remain the most sought-after by end users, other types are growing in demand. In a separate section of our report, we examined the types of single-use sensors that the industry would like to see introduced or improved. This year, pH and dissolved oxygen sen- sors remained at the top of the list, as they were last year. Of note, though, in- line titer sensors moved into the third position, up from the fifth spot last year. Also skipping a couple of positions this year was cell viability technology, the fifth-most-requested sensor introduc- tion or innovation. It's interesting to see that there are some somewhat contradictory results in our study, at least on the surface. For example, while demand for single- use sensor innovation is at its highest, our examination of specific single-use sensors found significantly dampened demand for many categories. That was the case for the following sensors: conductivity (22.9 percent this year, down from 37.7 percent last year) temperature (21.9 percent, down from 40.3 percent) UV (16.7 percent, down from 37.7 percent). The only sensors to see appreciably more demand this year were those noted above: in-line titer and cell viability. SENSOR TRENDS Our study offers up two potential trends: increased overall demand for better sensors, and a reduced desire for more specific sensors. In combination, these results suggest that the industry recog- nizes the need for better sensors, but there is less consensus about which types are most in need. Nevertheless, there's no doubt that the broad demand for sensor innovation is likely to grow, particularly as sensors are needed for improved assay and analyti- cal methods for process monitoring and control. Continued improvements in sen- sors, probes, and analytical equipment will indeed facilitate process quantifica- tion and process analytical technology (PAT). Thus, as bioprocessing becomes increasingly monitored by improved and new chemical, physical, and microbio- logical detection methods and assays — including single-use sensors/probes — the resulting data will be used for math- ematical modeling and risk analysis. One comment provided by a study partici- pant this year suggested that the lack of availability of reliable sensors capturing relevant data for process control is, in fact, hindering the adoption of PAT. Clearly, the industry feels the time has come for the introduction of better sensors. L Selected New Product Development Areas of Interest Figure1 Disposable Product: Probes, Sensors, Etc. Disposable Product: Bioreactors Cell Culture Media Disposable Products, Bag Connectors, Etc. Chromatography Products Disposable Product: Purif cation Control Systems Analytical Assays Analytical Development Fill Finish Services Cell Line Services Stainless-Steel Equipment Biomanufacturers & CMOs, 2014 (Top Areas Suppliers Should Focus Their Development Efforts On) 45.0% 34.9% 38.9% 22.1% 10.7% 40.3% 23.5% 37.6% 22.1% 4.7% 36.9% 20.1% BIOPROCESSORS DEMANDING SINGLE-USE SENSORS By E. Langer 0 6 1 4 _ B i o I n n o v a t i o n . i n d d 2 0614_BioInnovation.indd 2 5 / 2 1 / 2 0 1 4 1 : 5 8 : 2 1 P M 5/21/2014 1:58:21 PM