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BIO INNOVATION NOTES U.S. and EU markets. Thus, any innovation that streamlines, simplifies, or reduces bioprocessing costs will likely be viewed positively by this market segment. Protein A And Replacements: For a long time, Protein A has dominated initial recombinant antibody capture and purification. And with original Protein A-related patents held by Repligen and GE expiring, new entrants are rapidly entering the market. This includes higher-performing (e.g. high antibody-binding) and more generic broadly applicable Protein A separation resins, all essentially targeted to capture the markets held by the market leader, the Mab Select SuRe product line from GE. With Protein A quite expensive and essentially involving the use of one GMP-produced recombinant protein to purify another, the industry continues to seek more cost-effective alternatives. Other alternatives entering the market include high-capacity ion exchanger (CEX) resins; recombinant camel- (camelid) and llamaderived antibody-based resins, such as from BAC BV (now Life Technologies, Inc.); and custom-designed binding ligands, such as from Prometic Biosciences. Crystallization, polyethylene glycol (PEG) precipitation, expanded-bed absorption (EBA), and simulated moving-bed (SMB) chromatography will likely be among the other technologies entering the market in coming years that will be used for initial antibody capture and purification steps. Process Monitoring: Sensors and other devices to monitor processes are another area where new products and technologies continue to enter the market. Single-use sensors are in great demand, and available sensors are often not robust enough for use in bioreactors. Adoption of process analytical technology (PAT) continues slowly, with it not yet reduced to precanned software. Prepacked Chromatography Columns: Prepacked chromatography columns, generally used several times, are not yet single-use, but this is another area where suppliers are rapidly launching new products. BioPlan survey data shows that 27% of decision makers are now at least considering adopting prepacked columns. The number of vendors and variety of products available continues to increase. Protein A prepacked columns are expected to be launched in 2014. SUMMARY There continues to be widespread dissatisfaction with the pace of innovations in bioprocessing. For example, 44 percent of respondents to our annual study desire improvements to basic single-use components, 27 percent want analytical assays improvements, and 25 percent want to see cell culture products and technologies improve. This kind of demand will fuel the industry's R&D; expenditures for the foreseeable future. Growth Rate (CAGR) For Single-Use Products, All Stages R&D; And Manufacture Note: Not growth in sales; this is growth in application-first usage within a facility. Membrane Adsorbers 20.6% Bioreactors 20.6% 19.9% Mixing Systems Tangential Flow Filtration Devices Connectors, Clamps 8.1% 7.5% Source: 10th Annual Report and Survey of Biopharmaceutical Manufacturing Capacity and Production, April 2013 Survey Methodology: The BioPlan annual survey of biopharmaceutical manufacturers yields a composite view and trend analysis from over 300 responsible individuals at biopharmaceutical manufacturers and CMOs in 29 countries. The methodology included over 150 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, budgets in disposables, trends in downstream purification, 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. If you want to learn more about the report, please go to bioplanassociates.com. 22 LifeScienceLeader.com January 2014