SUMMARY
Those not paying attention to what's happening are likely to miss out on critical opportunities for both near- and long-term
process improvements. New purification technologies are being actively pursued by both vendors and end-users. Suppliers, such
as Pall Corporation's Global Technical Director Jon Petrone believes, "Downstream purification has the potential to become
a critical bottleneck in large-scale monoclonal antibody production as titers continue to increase."
Eric Grund, senior director of Biopharma Applications at GE Healthcare, agrees, "Resolving [downstream purification challenges]
with new, cost-effective technologies that will meet safety expectations is a priority ... flexibility is the most desired
feature of any downstream processing chain. A manufacturer may have to handle increased demand one day and alternative products
the next."
From the end-user's perspective, bioprocessing improvements are becoming a major focus. In fact, last year, over two-thirds
of biomanufacturers (67%) reported either "some" or "significant" improvements from changes to their downstream operations.2 This will continue as the industry deals with downstream processing challenges.
Disposable equipment may deliver the greatest shift in how biomanufacturing is done in the future. Today, a majority of manufacturers
are reporting the use of at least some single-use equipment in commercial-scale production. So, when fully disposable downstream
processes are introduced, there may be relatively rapid adoption and the potential for substantial growth. They may open the
way to completely modular, mobile biopharmaceutical operations. The cost, time, and quality improvements derived from single-use
components may then extend to separation and chromatography steps. In fact, most large biomanufacturers are now seriously
considering integrated disposable alternatives. According to Robert Blanck, bioprocess strategic marketing manager at Millipore
Corp., "We are working on new integrated disposable process solutions [that incorporate] bioreactor, chromatography, TFF,
virus filtration, sterile filtration, buffer/media storage, and intermediate handling."
More biopharmaceutical products are moving through the pipeline and cost pressures are continuing to mount.3 These competitive pressures are pushing new downstream technologies toward commercial and, ultimately, regulatory acceptance.
The next column will cover regulatory aspects and the receptivity of regulators toward adoption of new downstream processing
technologies.
Eric Langer is president and managing partner at BioPlan Associates, Inc., Rockville, MD. He is also a member of BioPharm International's editorial advisory board and the editor of Advances in Biopharmaceutical Technology in India, 301.921.5979, elanger@bioplanassociates.com
REFERENCES
1. 7th Annual Report and Survey of Biopharmaceutical Manufacturing. 2010 preliminary data. BioPlan Associates, Inc; Rockville,
MD. Available from: http://www.bioplanassociates.com/.
2. 6th Annual Report and Survey of Biopharmaceutical Manufacturing, April 2009 online edition. BioPlan Associates, Inc; Rockville,
MD. Available from: http://www.bioplanassociates.com/.
3. Rader RA. Biopharma:Biopharmaceutical Products in the US and European Markets. BioPlan Associates; Rockville, MD. Available
from: http://www.bioplanassociates.com/publications/pub_bpuseu.htm.
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