BIO INNOVATION NOTES
industry is seeking. Purification is an area of industry concern in 2013. In fact, the 450 global subject matter experts
and industry manufacturers on our Biotechnology Industry
Council pointed to aspects of downstream purification as
one of their most critical trends of the year.
The range of solutions being sought and proposed to
downstream purification problems is evident in the responses from our panel. For example, several micro-trends in
downstream bioprocessing include:
• alternatives to Protein A
• purification related to impurity profiles in biosimilars
• bioburden control in chromatography columns
• improving overall harvest operations.
As our studies show, some innovations will become integrated over time to resolve chronic problems, while others
will fade as the acute urgency for solutions is resolved.
Downstream Purification Technologies Being Considered (%)
2010-2013
Source: 10th Annual Report and Survey of Biopharmaceutical Manufacturing Capacity and Production, April 2013
0
10
20
30
40
50
Use Of High-Capacity Resins
Single-Use Filters
Buffer Dilution Systems/Skids
2013
2012
2011
2010
In-Line Buffer Dilution Systems
Single-Use Disposable TFF Membranes
Disposable UF Systems
Continuous Purification Systems
Survey Methodology: The 2013 10th Annual Report and Survey of Biopharmaceutical Manufacturing Capacity and Production is an evaluation
by BioPlan Associates, Inc. that yields a composite view of and trend analysis from 300 to 400 responsible individuals at biopharmaceutical
manufacturers and CMOs in 29 countries. The respondents also include more than 185 direct suppliers of materials, services, and equipment to
this industry. Each year the study covers issues including new product needs, facility budget changes, current capacity, future capacity constraints, expansions, use of disposables, trends and budgets in disposables, trends in downstream purification, quality management and control,
hiring, 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.
July 2013
LifeScienceLeader.com
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