Ben Locwin, PhD, MBA, MS, is
a contributing editor to Contract
Pharma and the president of
Healthcare Science Advisors. He is an expert
contact for the American Association of Pharmaceutical Scientists (AAPS), a committee member
of the American Statistical Association (ASA),
and has been featured by the CDC, the Associated Press, The Wall Street Journal, Forbes, and
other media outlets. Follow him at @BenLocwin.
Biomanufacturing Trends and
Outlook 2017: Where Is It All Going?
A look at the technological advances permeating (bio)pharma manufacturing
Compared with just two years ago, biomanufacturing continues to advance and evolve. For example,
according to BioPlan Associates’ 2015 annual report, more than 90% of facilities
were using single use/disposable technologies, and planning and future modeling was designed to balance out the
various costs and risks associated with
disposable vs. stainless steel technologies
for the long term.
Is technology the end-all?
Currently, more than 9 out of 10 contract
manufacturing organizations (CMOs) are
using disposables, and they are continuing to see benefits, though they are also
reporting some dissatisfaction with the
offerings and future trajectory of the disposables market.
Oftentimes, technology is erroneously
considered a proxy for the hard work and
activities in the industry. It’s easy to point
to something like wearable tech, social
media platforms, single-use disposables
and hold that as a mental heuristic for
the cause of pharma industry improve-
ments. But as the saying goes, “The map
is not the territory,” and just because
process improvements are happening
concurrently and coincidentally with the
use of disposables and other technology,
doesn’t mean that those are the key driv-
ers of that improvement.
Most organizations continue to report
that they are making improvements to
their processes and practices internally
and methodologically. Lean and Six Sig-
ma process improvement practices con-
tinue to be adopted, refined, and pushed
through organizations, which leads to
greater scrutiny of all business practices,
and opportunities to change how work is
approached. But because internal prac-
tices and methodologies aren’t measur-
able industry-wide in the same way that
total units sold of single-use technolo-
gies are, these work practice evolutions
tend to be minimized and under-report-
ed, when in reality are the unsung heroes
of industry improvement.
Increasing confidence in analytical
testing continues in the industry, and
the thinking tends to go that better
analytics and higher-precision analytical results leads to better performance,
which isn’t necessarily true. In the last
two years, however, there has been extraordinarily more focus and work on
biosimilars in the industry. The current
analytical requirements for biosimilars
are generally not stringent enough, and
according to many industry experts, perhaps not similar enough to the trial rigor
required of the innovator drug to make
biosimilars an area of continued large-scale refinement.