tems for new commercial manufacturing facilities in the next five
years and somewhat more rapid adoption of continuous bioprocessing at all scales, including commercial manufacture, particularly perfusion. Adoption will accelerate as perfusion and other
continuous bioprocessing technologies are improved.
However, perfusion and continuous bioprocessing, particularly
in near- and mid-term, will likely not become a predominant bioprocessing paradigm. Batch processing is simply too mature,
well-understood, well-accepted, and most equipment are still
oriented to this. Thus, perfusion and continuous bioprocessing
will have serious competition from legacy and state-of-the-art
batch bioprocessing for many users and uses, including in terms
of costs and overall cost-benefits. Perfusion and continuous bioprocessing will tend to be adopted where flexibility, lower capital
investment and facility costs, and operating at smaller scales, are
among the primary decision-driving factors.
1 11th Annual 11th Annual Report and Survey of
Biopharmaceutical Manufacturing Capacity and Production,
April 2014, BioPlan Associates, Inc. www.bioplanassociates.
ABOUT THE AUTHOR:
Eric S. Langer is president and managing partner at BioPlan
Associates, Inc. firstname.lastname@example.org, 301-921-5979.
clinical scale facilities, 37.4% cited single-use perfusion bioreactors and 19.4% cited stainless steel perfusion bioreactors.
PROBLEMS WITH PERFUSION
There are a number of current manufacturers actively using
perfusion, but some are not considering it for new products under development. Until perfusion becomes a common standard
across the industry, or is seen as being a more familiar or more
standardizable process development effort, adoption will be limited to larger scale processes or those especially suited to perfusion, according to Rick Johnston, Principal, Bio-G, Berkeley, CA.
Respondents in our 11th Annual Report and Survey of
Biomanufacturing Production and Capacity reporting problems
with perfusion vs. fed batch bioprocessing cited “Process complexity” as the primary concern, cited by 76.8%, with this significantly increased from 66.4% last year.
Batch processing requires large(r) bioreactors and other
equipment that cost more, take up more space, and require more
robust infrastructure, including utilities; plus processing, use of
labor, utilities use, etc. is intermittent, sporadic, and uneven. In
contrast, continuous bioprocessing allows more predictable manufacture of the same or more amount of product in bioreactors
and other equipment at smaller scales with lower associated
costs-savings and increased flexibility and other benefits.
BioPlan Associates projects rapid adoption of single-use sys-