The vision of Life Science Leader is to help facilitate connections and foster collaborations in pharma and med device development to get more life-saving and life-improving therapies to market in an efficient manner. Connect, Collaborate, Contribute
Issue link: https://lifescienceleadermag.epubxp.com/i/216720
BIO INNOVATION NOTES We continue to see a steady proportion of respondents stating that they expect to move away from Protein A over the next 12 months. But in this case, action doesn't always seem to follow intent. For example, despite about one-fourth of respondents saying they'd investigated alternatives to Protein A during the past year to improve downstream purification operations, only about five percent said they actually made a switch. In other words, of the respondents who were considering alternatives last year, only about 20 percent followed through. 5. High-Capacity Resins And Other Downstream Processing Innovations Facilities may be lukewarm in their pursuit of alternatives to protein A, but that attitude doesn't apply to all downstream technologies. In addition to interest in other high-capacity resins (showing a 10 percent point jump since 2010), decision makers are considering better single-use filters, an area that is also growing rapidly (e.g. from 29 percent in 2010 to 44 percent this year). Interestingly, when it comes to downstream purification, single-use disposable TFF (tangential flow filtration) membranes might be a new technology to keep an eye out for. As mentioned in previous columns, we see CMOs as the catalysts for industrywide adoption of innovative technologies, and they seem particularly drawn to disposable TFF membranes this year. FACTORS CREATING DEMAND FOR INNOVATION Almost a year ago, we asked the more than 450 global subject matter experts and senior biopharma participants who make up our Biotechnology Industry Council to identify the macro trends in the industry, along with their vision for the future. Here are some of the areas they expect will be driving the "innovation dialog": • • • • • • • more multiproduct facilities more single-use adoption at commercial-scale biomanufacturing more continuous processing more automation, requiring increased process monitoring development of better characterization tools and improved high-throughput, high-resolution glycosylation analysis better models for demonstrating biosimilarity design strategies that emphasize flexibility, adaptability to new enabling technologies, clone-ability of spaces, equipment separation, and centralized material support. We are excited to follow where these developments will bring us in 2014. Biomanufacturers' Top Trends, 2013 Downstream Processing 24% Others 30% Single Use: Implementing & Improving 22% Analytical Methods 24% 450 Biotech Industry Council responses to trends for 2013, Dec. 2012. Others = platforms, cost reductions, materials sourcing, supply chain regulatory compliance, biosimilars, etc. 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 yearÕs 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 worldÕs major markets in the U.S. and Europe. If you want to learn more about the report, please go to bioplanassociates.com. December 2013 LifeScienceLeader.com 17