With announced layoffs and restructuring, we'd expect increased plans to use outside contract manufacturing and development
services, but there seems to be no appreciable increase over last year. Thirty-three percent (versus 30% last year) say their
companies intend to outsource some aspect of their biotherapeutic manufacturing program, whereas 51% do not (versus 50% last
year). Interestingly, the reasons for outsourcing have changed somewhat.
Figure 6: Process analytical technologies used (multiple answers allowed).
This year, fewer respondents—45%, compared with 59% last year—say their companies lack biomanufacturing capacity, and 41%
versus 45% last year, cite cost effectiveness. More respondents, 30% this year as opposed to 25% last year, say their companies
outsource because they've increased manufacturing output—by increasing the number of products they manufacture, or by increasing
the volume output of existing products. Fewer respondents say their companies lack the expertise in house, with only 13% citing
that as a reason this year compared with 19% last year.
Among those who do outsource, 49% outsource the manufacture of both drug substances and finished products, down 14% from 63%
last year (see Figure 5). Forty-two percent outsource API manufacture, and 31% outsource finished products. Thirty-nine percent
outsource the manufacture of materials for clinical trials, and 34% outsource their full-scale commercial manufacturing. Twenty-six
percent outsource process development activities, and 19% outsource formulation development.
Figure 7: Current technical challenges faced by manufacturers of cells for tissue or cell-based therapies (multiple answers
Quality by design
It's been a few years since FDA rolled out its quality-by-design (QbD) initiative, and we would have anticipated that more
companies would have incorporated QbD principles into their manufacturing paradigm. So it came as something of a surprise
to see a slight decline in respondents reporting the use of QbD in their biopharmaceutical manufacturing operations—67% this
year, versus 70% last year. Nevertheless, 13% more respondents say they understand the initiative this year, bringing the
percentage up to 62%. Furthermore, only 38% say they lack guidance and direction from regulatory agencies, as compared with
46% last year, and 23% more respondents than last year see the process and quality advantages to the QbD program. In spite
of the fact that more respondents understand and appreciate the benefits of QbD, 17% cite cost as an impediment to implementation.
Among those who do incorporate QbD, 71% say it has improved process understanding, 51% say they've seen improvements in product
quality, 49% say they've realized greater manufacturing efficiencies, and 45% say QbD has reduced variability in product quality.
Twenty-eight percent say the initiative has reduced costs, but this is down from 38% who said the same thing last year. Finally,
23% credit QbD with speeding regulatory approvals.
Figure 8: Current technical challenges faced by manufacturers of nucleic-acid based drugs (multiple answers allowed).
Fifty-three percent of respondents incorporate process analytic technologies (PAT) into their manufacturing operations, about
the same as last year. Among those who do use PAT, the most widely used technology is high-performance liquid chromatography
(HPLC) (73%), followed by 46% who use spectroscopy (other than near infrared spectroscopy [NIR] or Fourier transform infrared
spectroscopy [FT-IR]), 43% who use chromatography (other than HPLC or ultra-performance liquid chromatography), 31% who use
NIR, and 28% who use FT-IR (see Figure 6).
This year, as we hopefully recover from the recession, one might expect spending to increase over last year. This year, 31%
of respondents anticipate their companies to increase spending on biopharmaceutical manufacturing activities. But if history
is any predictor, respondents tend to underestimate spend. Last year, 29% anticipated spending increases in 2009, compared
with 41% percent of respondents who report that their companies actually did increase spending.
Figure 9: Purification technologies used by respondents for manufacturing proteins (multiple answers allowed).