Process analytical technology
Figure 6 Does your company incorporate process analytical technology (PAT) into your manufacturing line?
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The survey also examined the importance of PAT in the manufacturing activities of respondents. More than half (56%) said that
their companies do not incorporate PAT into their manufacturing lines, and nearly 44% do (see Figure 6).
Innovator drug companies lead in PAT implementation. Approximately 55% of innovator pharmaceutical firms said they have incorporated
PAT into their manufacturing lines, and roughly 49% of biotechnology companies and 46% of consumer healthcare companies have.
Thirty-two percent of generic-drug companies and 23% of contract manufacturers have implemented PAT.
Among respondents whose companies use PAT in their manufacturing lines, the most common benefits PAT has brought to their
production process are better process understanding (71% said so) and increased efficiency or reduced waste (57%). For those
companies not using PAT, the most common reason why they do not use it is that the benefits do not justify the necessary effort
(49% said so) and that it is expensive (31%).
Stainless steel versus disposables
Figure 7 Does your company use disposables or single-use components in your biopharmaceutical manufacturing?
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The survey also examined the spending and interest in the use of disposables or single-use components in biopharmaceutical
manufacturing compared with stainless-steel systems. More than half (55%) of respondents said their companies used disposables
or single-use components in their biopharmaceutical manufacturing (see Figure 7). The penetration of disposables use was greatest
among biotechnology companies (87% of biotechnology companies use disposables), followed by innovator pharmaceutical companies
(62%), contract manufacturers (46%), consumer healthcare companies (18%), and generic-drug companies (15%).
Figure 8 For future purchases of bioreactors, are you more inclined to purchase
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Although more than a majority of companies use disposables, 44% were undecided whether they would buy a single-use or stainless-
steel bioreactor for future purchases (see Figure 8). Only 6% said that they had a preference for purchasing single-use bioreactors
and nearly 18% had a preference for stainless-steel bioreactors (see Figure 8).
Gauging innovation
Respondents profile
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Disposables or single-use components and equipment for biologic-based APIs were high on the innovation curve. Thirty percent
of respondents rated product innovation high for disposables or single-use components in biopharmaceutical manufacturing,
and 22% ranked innovation in equipment for manufacturing biologic-based APIs as high. Also receiving strong marks for innovation
were laboratory equipment (23% of respondents ranked it as high) and machinery for quality assurance and quality control (17%).
Innovation is significant when making a purchasing decision. Fifty-eight percent of respondents said innovation was "extremely"
or "very" important in influencing their decision to buy equipment and machinery. Respondents also said that they were generally
satisfied with the level of product innovation in 2008. Eighty-two percent of respondents said there were not new product
innovations that they had anticipated for 2008 but were not commercialized. Seventy-two percent said there were not innovations
in existing equipment that they had hoped for, but were not made.
Reference
1. P. Van Arnum, "Pharmaceutical Technology's Equipment and Machinery Trends Survey," Pharm. Technol.
32 (3), 64–70 (2008).
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