Outsourcing
Figure 6: Types of projects outsourced. API is active pharmaceutical ingredient.
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We hear that, in general, pharmaceutical manufacturers are outsourcing more, so we wondered how much biopharmaceutical manufacturing
is outsourced. Among our respondents, 30% outsource biotherapeutic manufacturing, and 50% do not. The remaining 20% do not
know whether their company outsources. But among those who do outsource, 63% outsource both active pharmaceutical ingredient
(API) and finished product manufacture; 18% outsource API manufacture only, and the remaining 19% outsource finished products
only (see Figure 6). Fifty-nine percent of those who outsource say they do so because their companies have no or limited biopharmaceutical
manufacturing capacity, and 45% say it is simply more cost effective to outsource. Nineteen percent say their companies outsource
because they lack the technical expertise to manufacture biopharmaceuticals (see Table V).
Quality by design
Table V: Reasons for outsourcing biotherapeutics manufacturing (multiple responses allowed).
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So much of the focus on quality by design (QbD) has been directed toward small-molecule manufacturing, so we wondered how
QbD initiatives were playing out for biopharmaceutical manufacturers. Fully 70% of biopharmaceutical manufacturers incorporate
QbD principles into their process design. Among those who don't, 48% say they don't see any advantages to be gained by using
QBD; 38% say they don't understand the initiatives; and an equal number—38%—say they lack direction from regulatory authorities.
Seventeen percent say QbD initiatives are too costly.
Figure 7: Process analytical technology techniques used. Total exceeds 100% as multiple responses were allowed.
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Fifty-two percent of respondents use process analytical technology (PAT) in their biopharmaceutical manufacturing operations,
while 26% don't, and 23% don't know. Of those who do incorporate PAT, 81% claimed they gained better process understanding;
67% report increased manufacturing efficiency; 47% say they've achieved better regulatory compliance; and 38% say they've
reduced costs as a result of PAT implementation. Sixty-seven percent incorporate chromatography into their process analytics;
42% use spectroscopy; and 13.5% use other technologies, including various forms of infrared spectrometry (see Figure 7).
Spending
Finally, we asked about past and future plans to spend on equipment for biopharmaceutical manufacturing. Although half of
the respondents did not know how much, as a percentage of sales, their companies spent on biopharmaceutical manufacturing
in 2008, 34% said their companies spent up to 8%. An additional 11% thought their companies devoted more than 10% of sales
revenues to biopharmaceutical manufacturing equipment. Thirty percent of respondents expect their companies to allocate up
to 8% of 2009 sales on the purchase of equipment related to biopharmaceutical manufacturing. Eight percent expect their companies'
2009 spending to exceed 10% of sales; 58% don't know. Twenty-nine percent of respondents think their companies will increase
their spending over 2008 on biopharmaceutical manufacturing in 2009. Who knows? Maybe that investment banker was right after
all.
Respondents profile
The Pharmaceutical Technology Biopharmaceutical Manufacturing Survey targeted individuals who work for companies engaged in biopharmaceutical manufacturing.
Thirty-five percent of respondents work for innovator pharmaceutical companies, 29% work for biotechnology companies; 12%
work for contract manufacturers; and 3% work for generic drug manufacturers. Respondents' companies mean annual sales revenues
are $11.8 billion.
Twenty-six percent of respondents are engaged in research; 24% work in production management; and 19% work in QA/QC analysis.
The total mean biopharmaceutical experience of respondents is 16 years, and their mean age is 46.5 years. Eighty-nine percent
of respondents work in the United States, including Puerto Rico; 4.2% work in Western Europe; and 3.3% work in Canada. The
survey was developed by Pharmaceutical Technology and Advanstar's corporate research department and reflects the responses of 239 participants.
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