The latest results from an ongoing survey on the use of process analytical technologies (PAT) show that pharmaceutical and biopharmaceutical companies are making a greater commitment to PAT, but can do much more to meet the needs of plant professionals. The findings were made public at a recent Pharmaceutical Process Analytics Roundtable meeting hosted by Genentech in San Francisco. The survey asks each participating company about its broad uses of PAT, then narrows its focus to examine PAT in manufacturing and R&D. The number of companies responding this year rose from 9 to 12—not a huge sampling, certainly, but enough to indicate important trends—in staffing and funding, and in applications and obstacles of different technologies.
Broad Results
Most respondents said their companies have dedicated resources specifically to PAT. 75% of respondents, or nine of 12, said they have a specially designated PAT team; 25% do not, relatively unchanged from previous years’ responses. PAT teams seem to be getting larger, however. This year, 44% of respondents said their companies had assigned between 11 and 15 people to PAT projects; 11% had more than 15 working on PAT projects, while 22% said they’d assigned from one to five people, and an equal number, six to 10. In comparison, in 2001, 43% of responding companies had six to 10 people assigned to PAT, while 29% had 11 to 15 and an equal percentage, more than 15.
Almost all of the companies surveyed, 89%, said they had people outside their official PAT group working on PAT projects. Interaction between these official and unofficial PAT groups seems to be on the rise: this year, 88% of respondents said that official PAT-designated employees worked as members of teams involved in specific ongoing PAT projects, up from 75% last year.
PAT projects continue to be most closely aligned with analytics, engineering and technical services. Analytics accounted for 56% of respondents’ PAT efforts this year, engineering for 22%, and tech services, 33%. Last year, corresponding figures were 57%, 29% and 43%.
Although PAT projects are mainly funded on an individual project level, more corporate budgets include provisions for PAT activities. This year, 44% of respondents said the budget provided for PAT efforts, up from 29% last year.
Asked which technologies were most widely used, survey participants selected NIR, pH, and conductivity. 90% of respondents use pH and an equal number use NIR, 80% use conductivity, and 70%, UV-Vis. None said they are using Raman, compared with 43% last year. Mass spectroscopy was cited by 40% of respondents, while one company, or 10%, is using imaging.
For closed-loop control, 80% of respondents are using pH, 50% are using conductivity, and 50% are using UV-Vis.
The number of installations appears to be stabilizing. This year, 30% of respondents said they have over 100 PAT instrumentation installations, down from 57% the year before, while 30% said they have between 10 and 50, down from 43% last year. However, 20% have between 50 and 100, up from 0% last year, and 11% in 2001.
Involvement with external PAT groups varies, and pharmaceutical companies appear to be diversifying their PAT affiliations. One third of respondents were involved in PhRMA’s PAT committee, unchanged from last year. Also, 25% are involved in CPAC, 17% in CPPR and 17% in MCEC. Participation in “other” groups increased from 0% in 2001, to 22% last year and 33% this year.
In Manufacturing
Within manufacturing, 83% of respondents are using PAT, roughly the same as last year. All are using it for “in-process checks,” unchanged from last year. Half are using PAT for quality assurance, while 30% are using it for final product release testing.
When asked about the current status of online analytical technologies in manufacturing, the response was conclusive. 80% felt that we “have barely scratched the surface” of what PAT has to offer, while the remaining 20% said there is still much value to be captured. None of the participants felt that we are where we should be with PAT.
Companies were fairly divided in terms of what the greatest barriers to implementing PAT are. Four of 12 said that PAT technologies are not currently part of their process development efforts. Three cited a lack of robust technology, while three said a lack of long-term support for PAT. Just two of 12 cited FDA regulations as being prohibitive.
Who provides support and maintenance when something goes wrong? Half said that plant operators and engineers handle the duties. Four of 10 said that the designated PAT group does, two said vendors do the work, and two said a site champion does.
For the future of PAT, the greatest needs seem to lie within organizations and technology. Six of 10 said an organizational commitment to PAT is necessary, while five said that technology development is key. Only one respondent said that costs would be prohibitive and that there is a real need for cheaper PAT options.
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