Equipment
Survey results indicated a slight shift in the type of bioprocessing equipment that is being used this year compared with
2011. Most respondents, 66%, indicated that they used a hybrid system containing both stainless and disposable elements,
which is unchanged from last year's results. However, the numbers indicating that they used stainless-only systems declined
slightly, from 26% in 2011 to 21.8% this year. And the number of all-disposable users inched up proportionally, from 8.4%
last year to 12.2% this year. Of those using an all-stainless system, 31% indicated that they had no plans to change their
equipment, but 25% said they planned to move to a hybrid system. In contrast, most users of all disposable systems (59%)
said they had no plans to change their equipment and only 13.6% said they'd be adding some stainless into the mix and moving
to a hybrid system.
Figure 3: Whether or not you currently use disposables, what in your opinion is (are) the greatest advantage(s) to disposable
equipment (multiple responses allowed)?
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When asked about the relative strengths and weakness of disposable bioprocessing equipment, respondents focused on a few key
attributes. When asked, whether or not they used disposables, to identify the greatest advantages to using single-use components,
the highest-ranking attributes were reducing contamination, time savings, ease of use, and flexibility for multiproduct manufacturing
(see Figure 2). High cost was seen to be the biggest drawback to disposables, followed by high environmental impact, concerns
about leachables, and limitations on size. Those who use only stainless have largely the same opinions as those who use disposables.
The only concern that ranked lower among stainless-only users than the population at large was leachables: 21% of stainless-only
users ranked it as a drawback to the technology, compared with 33% of the group as a whole.
Quality by design and process analytical technology
A solid majority of survey participants, 62%, say that their companies incorporate quality by design (QbD) into their manufacturing
processes; this percentage is similar to last year's response of 65%. Those who identified themselves as working at an innovator
company were somewhat more likely to employ QbD than the sample at large, at 79%. Reasons given for doing so were to gain
greater process understanding (71%), improve product quality (57%), reduce product variability (53%), and to improve manufacturing
efficiency (51%). Of those who do not employ QbD, 34% say that they don't see the process or quality advantages to be gained,
while 27% say they don't understand the initiative, and another 27% responded that they thought it would be too costly to
implement.
Respondents were evenly split on whether they used process analytical technology (PAT), 45.7% did and 54.3% did not, again,
little changed from last year. Sixty-two percent of those who use PAT say they use high-performance liquid chromatography
as one of their analytical technologies, with the second most popular technology being other types of chromatography, at 45%.
Capacity and outsourcing
Fifty-five percent of respondents indicated that their companies increased biomanufacturing capacity over the past year, up
slightly from last year (50.5%). Large companies drove a greater share of the increase, with 69% from companies with revenues
more than $1 billion indicating an increase in capacity. The most common reason for the increase in capacity was increased
production of an existing product (57.5%), followed by the addition of new products (44.7%) and the internal development of
new products (41%). Of those companies that did not increase production, most (71.3%) said that production was holding steady,
rather than decreasing. Rather than a boom, it looks like a steady rate of increase in capacity, with those not increasing
production at least holding their ground.
Only a minority of the survey respondents indicated that they outsourced the manufacture of biologics (30%), with the most
commonly outsourced product being drug substances (APIs, 45%), and clinical trial materials (41%). Finished products (24%)
and formulation (19%) were least likely to be outsourced. When asked about their reasons for doing so, 51% indicated that
it was because their company had limited in-house capabilities, and 41% indicated that outsourcing was more cost-effective
than doing it themselves.
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