n 16 MAY 2015 | PHARMACEUTICAL PROCESSING
n BIOPHARMACEUTICAL TRENDS ■ P H A R M P R O . C O M
Downstream processing contin- ues to impact capacity at the majority of biopharmaceuti- cal manufacturing facilities,
and industry respondents are clamoring for advances in this area, according
to our soon-to-be-released 12th Annual
Report and Survey of Biopharmaceutical
Manufacturing Capacity and Production .
Indeed, manufacturers we surveyed for
this year’s report are considering a range
of new technologies to help ease the bottlenecks they’re currently experiencing.
Downstream processing’s inability to
keep pace with upstream advances in
recent years have been well-documented,
and our annual studies have shown for
some time that downstream is contributing to significant capacity bottlenecks at
respondents’ facilities. With that in mind,
it’s not too surprising that many biomanufacturers are insisting that the industry
focus on downstream advances this year.
When we asked industry respondents to
identify the single most important biomanufacturing trend or operational area that
the industry must focus its efforts on this
year, downstream processing advances
emerged as the second-leading area.
So, for the industry as a whole, downstream processing now ranks as a bigger
concern than manufacturing cost reductions and single-use system integration
This year’s result marks a significant
departure from last year, when downstream processing advances ranked as
only the 6th-most important trend to
respondents, behind the likes of biosimi-lars and continuous processing. As such,
the industry appears to be coming to the
conclusion that it’s time for downstream
processing advances to emerge.
INNOVATIONS ARE MOST IN-
Almost all (97.4 percent) of qualified
industry respondents this year said that
they are considering new downstream
purification technologies. Presented with
a wide range of technologies, the following emerged as those most broadly in active consideration to address production
issues or problems: (place graph 2 here)
The results contain some interesting
divergences from last year. For example,
active interest in continuous purification
systems showed a significant rise from
32. 4 percent of respondents last year to
half in this latest report, while fewer respondents this year expressed interest in
membrane technology, one of last year’s
leaders (39 percent vs. 49 percent).
Also of note: More than one-third (37
percent) of respondents this year reported actively considering alternatives to
chromatography, with this representing a
large increase from last year’s 21 percent,
and by far the largest share of respondents signaling an interest this decade.
The uptick in consideration of chroma-
tography alternatives aligns with separate
results from our survey indicating close
attention to chromatography. In fact,
Tellingly, chromatography products
were joined at the top by disposable pu-
rification products (also 36 percent), sup-
porting the industry’s need for advances
in downstream processing. Last year,
these areas ranked 5th and 6th, respec-
tively, in terms of new product develop-
ment areas of interest.
The industry’s renewed attention
to downstream processing advances
appears to be backed by budget increases, too, as almost two-thirds (66
percent) of survey respondents said
they would increase their funding for
new technologies to improve efficien-cies/cost for downstream production.
That led all areas, surpassing the 62
percent planning increases in new
capital equipment spending and the 59
percent expecting to grow their budgets
for process development.
Those latter areas will see more significant budget increases, though, as new
capital equipment spending is tabbed for
an overall spending increase of 6.1 percent, compared to a 5. 3 percent hike for
process development and a 5. 2 percent
estimated increase for new downstream
production technologies. Nevertheless,
the 5. 2 percent growth for downstream
technologies ranks as the largest forecast increase in this area since 2012.
HOW ARE MANUFACTURERS
Interest in novel technologies is
clearly growing, but it’s also important
BioPharma Industry Seeks
Continuous purification systems and chromatography alternatives are in