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BIO INNOVATION NOTES percent) and to have switched to alternatives to Protein A (15 percent). This may be due to the construction of newer ROW facilities that have enabled them to consider alternatives to legacy purification processes. Or, perhaps, ROW respondents simply have less need or concern regarding meeting major market cGMP and major market regulatory standards, with Protein A long the standard for initial mAb capture, which has allowed them to more quickly consider and adopt alternatives. But contrary to this finding, overall, ROW facilities are doing much less investigation of bottlenecks and adopting of alternative downstream technologies. WHAT'S TO COME? This year, we continue to see a decrease in the percentage of biomanufacturers indicating that they expect to move away from Protein A. Thus, the current dominance of Protein A products for initial mAb capture can be expected to continue. We can expect the market for Protein A products to remain stable in the nearterm, other than shifts and increases associated with new major commercial products coming online. Those products also may take some time to develop. Perhaps in response to lessening demand on the part of end users, fewer suppliers are working on Protein A alternatives, according to our study. Indeed, only 15 percent of supplier respondents cited "chromatography, alternatives to Protein A" as a top-new technology or new product development area their company is working on in biomanufacturing. That figure is down from 19 percent last year and 23 percent the year before. What's more, the $12,000 to $15,000 per-liter cost for Protein A and its recyclability makes disposable options for current products unlikely. It's worth noting that the introduction and adoption of recombinant Protein A products in recent years in place of legacy nonrecombinant Protein A products may be contributing to a less perceived need to adopt Protein A alternatives. There's reason to believe that the industry will continue to seek alternatives to Protein A: A recent survey we conducted among a panel of hundreds of biotechnology experts found alternatives to Protein A emerging as a key micro-trend to watch. In the end, though, it seems simply that while many firms would like to avoid the high cost of Protein A affinity resin, most are reluctant to make changes to existing processes, particularly as there continue to be few, if any, proven alternatives. Figure 1: Issues Regarding Protein A In Downstream Puriļ¬cation Agree Strongly Agree 2% 31.4% For new production units, I am considering alternatives to Protein A. For existing production units, I am considering alternatives to Protein A. 10% I will be moving away from Protein A for existing scale-up or commercial production units over the next 12 months. 14% Survey Methodology: The 2013 Tenth Annual Report and Survey of Biopharmaceutical Manufacturing Capacity and Production 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 October 2013