By Eric Langer, president and managing partner, BioPlan Associates, Inc.
Vendors are investing heavily in new technologies and products for downstream purification. In our 8th Annual Report and Survey of Biopharmaceutical Manufacturing, we asked 180 suppliers to the biopharmaceutical industry to identify the top new technology areas currently in development at their company. The results, not surprisingly, correlated well with the survey’s 352 biopharmaceutical drug manufacturers’ demands for better technologies.
New disposable single-use devices, including those for downstream applications, are what the largest percentage of vendors in this industry are working on. The same percentage of vendor respondents noted bioprocess development services (indicated by 40.5% of vendors). Disposable chromatography is the third hottest R&D area, with 34.2% of vendors.
Increasing use of disposable products and the demand for new downstream purification technologies are driving investment and directing vendors’ R&D in these areas. Today, both developers and CMOs are expecting that physical capacity of downstream purification equipment will continue to constrain facility capacity in the near term. So, we are seeing research and improvements in purification technologies that will likely move this industry bottleneck forward.
Among biomanufacturers, our results show that the downstream technologies in demand in 2010 continue to be sought after this year, but by an even larger percentage of respondents. This suggests that the problems from previous years have not been adequately resolved: cost of chromatography materials, cost of membranes, and the time for operations. This year there was also strong interest among biomanufacturers for high-capacity resins and in-line buffer dilution systems. The most rapid growth has been in single-use prepacked columns, which jumped from single digits last year to 32% this year. We asked our respondents about new downstream processing technologies that they are actively considering to address bottlenecks and problems. Areas of opportunity for addressing these issues include:
In-line buffer dilution systems
Single-use disposable TFF (tangential flow filtration) membranes
Buffer dilution systems/skid
Moving bed technologies
mAb (monoclonal antibodies) fragments
Problem Areas In Downstream Operations
Column chromatography remains the major concern in downstream operations. Of all the unit operations performed during downstream processing of bulk drug substance, chromatography is the most challenging and has the gravest consequences when things go wrong. Areas where biomanufacturers see room for improvement include: faster-flow resins, greater binding capacity resins, better membrane separation technologies, and better UF (ultrafiltration)-membranes.
According to Scott Wheelwright, Ph.D., president at Strategic Manufacturing Worldwide, Inc., “The relative ranking of each of the [downstream] issues rarely varies by more than one position; that is, the issues induce more or less the same relative level of anxiety year after year.” So far, although incremental improvements have emerged, we have yet to see groundbreaking alternatives to current filtration and chromatography methods. Even when new technologies are introduced, the rigid regulatory nature of biomanufacturing will likely result in gradual adoption of any new approaches.
Survey Methodology: This eighth in the series of annual evaluations by BioPlan Associates, Inc. yields a composite view and trend analysis from 352 individuals at biopharmaceutical manufacturers and CMOs from 31 countries. The methodology also encompassed an additional 186 direct suppliers (vendors) of materials, services, and equipment to this industry. This year’s survey covers such issues as: current capacity, future capacity constraints, expansions, use of disposables, trends and budgets in disposables, trends in downstream purification, quality management and control, hiring, employment, and training. The quantitative trend analysis provides details and comparisons by both biotherapeutic developers and CMOs. It also evaluates trends over time and assesses differences in the world’s major markets.