maceutical manufacturing. That was a
significant uptick from two-thirds agreeing that this was a concern last year, and
it was also the first time since 2010 that
L&E concerns affected a larger share of
CMOs than biodevelopers.
Interestingly, an equal share of CMOs
this year (83.3%) said that the high cost of
disposables could restrict their use of disposables, suggesting that cost is perhaps
as big a hindrance as L&E concerns. But,
on closer examination, L&E concerns appear to be top of mind for CMOs.
The L&E issue is also apparent when we
asked respondents to indicate the single
most critical reason for not increasing use
of disposable technologies, one-third of
CMOs (vs 19.2% of biodevelopers) cited
L&E concerns, with another 16.7% pointing
to the lack of clear regulatory guidance on L&E. In other words, L&E concerns – in one
way or another - are the biggest annoyance for half of CMOs. By comparison, 1 in 6 cited
the high cost of disposables to be their single most important reason for not increasing
use of disposable technologies.
Increased concerns for leachables and extractables may be due to increases in the
transition of products produced using disposables moving into later stage clinical development, with regulatory filings looming. Over time, though, these L&E concerns ought
to subside as the industry pressure necessitates a solution, and both CMOs and product
developers/manufacturers will likely integrate disposables into most or all their bioprocesses. This will be dictated by economics, risk reduction and speed.
In addition, as new regions, such as China and India, begin to produce both innovative biopharmaceuticals and biosimilars/biogenerics, even if only for their domestic markets, the need for consistent quality will likely dictate the greater use of
disposables, because they can be implemented more efficiently, rapidly, with fewer
risks of quality problems and with much less required infrastructure. As use of disposable equipment continues to mature, the industry will have CMOs to thank for
leading the charge towards disposable adoption.
The benefits afforded by use of single-use equipment fit very well with the CMO business model; CMO use of single-use systems can save on facility and campaign costs,
which can also reduce operating costs and capital investments. This is consistent
with the adoption process and philosophy for other novel technologies as well. In the
case of disposables, the flexibility and quick turn-around times between process runs
allowed by single-use equipment can also improve efficiency, which can reduce costs.
These savings can be passed on to CMO clients, increasing the cost-benefit calculus,
and, potentially, profits. This is often the result of being able to perform different processes within the same facility more rapidly.
1. 11th Annual Report and Survey of Biopharmaceutical Manufacturing Capacity and
Production, April 2014, Rockville, MD www.bioplanassociates.com/11th
ABOUT THE AUTHOR:
Eric S. Langer is President and Managing Partner at BioPlan Associates, Inc., Rockville,
MD. firstname.lastname@example.org; 301-921-5979. www.bioplanassociates.com
Survey Methodology: The 2014
Eleventh Annual Report and Survey
of Biopharmaceutical Manufacturing
Capacity and Production yields a com-
posite view and trend analysis from
238 responsible individuals at biopharmaceutical manufacturers and contract
manufacturing organizations (CMOs) in 30
countries. The methodology also included
158 direct suppliers of materials, services
and equipment to this industry. This year’s
study covers such issues as: 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 issues, 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.