PAT and QbD
The survey also examined the degree to which newer technologies, such as those relevant for PAT and QbD, are being applied
and to what extent do they influence purchasing decisions on equipment and machinery. The survey showed that 57.6% of respondents
do not incorporate PAT into their manufacturing activities, and 42.4% do. For those companies that do incorporate PAT, the
leading benefits were better process understanding (64.2% of respondents cited as such) and increased efficiency or reduced
waste (60.4% of respondents) (see Figure 1). For those companies using PAT, half increased their spending on machinery and
equipment related to PAT in 2010, and half did not. For 2011, for those companies using PAT, slightly more (53.7%) will increase
spending on PAT-related applications. For those companies not using PAT, 37.5% said the benefits don't justify the costs,
and 26.4% said they do not use PAT because PAT would require modifications to equipment and procedures.
Figure 1: Benefits of process analytical technology (PAT) cited by survey respondents.
Areas of spend
. Similar to spending trends in 2009, the survey showed that the areas of highest spending for equipment and machinery in
2010 were in solid-dosage manufacturing, parenteral/aseptic/sterile manufacturing, and manufacturing for biologic-based active
pharmaceutical ingredients (APIs), although the distribution of that spending reflected less spending on equipment for manufacturing
solid-dosage forms and more for biologic-based APIs. The survey showed that 24% of respondents spent the most on equipment
and machinery in 2010 for the manufacturing of solid-dosage forms (24.0%), followed by biologic-based APIs (17.5%), and then
parenterals (13.6%)(see Figure 2). In 2009, 31% spent the most for solid-dosage manufacturing equipment, 18.5% spent the
most on parenteral/aseptic/sterile manufacturing, and 15.8% spent the most on biologic-based APIs (1).
Figure 2: Areas of highest expenditures for equipment and machinery in 2010. API is active pharmaceutical ingredient.
The survey further examined spending habits in equipment categories. The results showed the following trends for those that
increased spending or kept spending the same in 2010 compared with 2009:
- 39.6% increased spending on solid-dosage equipment; 48.1% kept it the same
- 35.9% of respondents increased spending on equipment and machinery for quality assurance/quality control; 50.4% kept it the
- 35.5% increased spending for finished product, high-potency/high-containment manufacturing; 69.4% kept it the same
- 33.8% increased spending for biologic API manufacturing; 52.1% kept it the same
- 33.3% increased spending for API, high-potency/high-containment manufacturing; 52.4% kept it the same
- 31.2% increased spending for continuous processing technology, finished product; 54.5% kept it the same
- 30.7% increased spending for parenteral/sterile/aseptic manufacturing; 56.8% kept it the same
- 27.6% increased spending for chemical API manufacturing; 48.7% kept it the same
- 11.9% increased spending for continuous processing technology; API 64.4% kept it the same